Tag: quality compliance

FDA Medical Device Guidance

Posted on by Brandon Miller

The FDA Center for Devices and Radiological Health (CDRH) recently published new guidance for medical device priorities in 2023. The FDA CDRH guidance looks to evolve away from the COVID-19 pandemic and transition toward digital health, medical device software and regulated software as a medical device (SaMD).

 

Cybersecurity for Medical Devices

 

Among topics the FDA guidance considers “A-List” priorities is cybersecurity for medical devices. Two initial priorities of the FDA guidance will include a deeper study of quality system (QMS) considerations and premarket submission (PMA) content.

 

Additional FDA software guidance was published earlier this year (September 2022) that described how software functions meet the definition of a medical device and risks to the public. The change industry should keep an eye on is FDA product specific guidance that applies to regulating software development that impacts risk to patient safety.

 

Quality Management System

 

Quality management system regulation currently falls under 21 CFR 820, so it will be interesting to see how new updates are developed based on discussion with industry. Every medical device manufacturer is required to have a compliant QMS system that includes the necessary QMS documentation for regulatory approval.

 

As digital healthcare integrates the physician-patient relationship, FDA continues to scrutinize device software functions and healthcare mobile apps. Lastly, these insights may provide additfeedback on software functions not subject to FDA regulatory requirements relevant to a QMS audit.

 

Remanufacturing Medical Devices

 

FDA is taking a deeper look at reusable medical devices and how preventive maintenance increases the life of a medical device. Currently, there are separate regulations for both industry manufacturers and 3rd party service companies. FDA will look to clarify the differences between “servicing” and “remanufacturing”, and the impact on medical device safety for either. This will likely impact the regulatory responsibilities of companies who perform these activities for health care providers.

 

Premarket Authorization (PMA)

 

Software as a medical device continues to grow across the health care industry. Updated premarket authorization guidance will focus on software devices with consideration to how the software is delivered to the end user. This can include factory-installed healthcare software or platforms installed by a third-party vendor.

 

Equally important, new information is anticipated for different types of firmware and software-based control of medical devices. Industry employees should also anticipate greater clarity for stand-alone software applications and general purpose computers. Leadership at FDA has included subtle hints that accessories to medical devices that include software may also be included in future FDA guidance for industry.

 

COVID-19 Emergency Use Authorization (EUA)

 

There has been discussion around the 180-day timeline proposed for notice of ending a medical device EUA due to COVID-19. Final guidance should be available in 2023 that provides more detail about on the appropriate transition period. FDA is considering industry recommendations that avoid disruptions to product shortage and supply chain.

 

Further, consideration is also being given to medical device manufacturer and healthcare providers to adjust from policies adopted during the public health emergency (PHE). For example, an EUA issued under section 564 of the FD&C Act will remain in effect. Primary changes will be based on if FDA chooses to revoke the EUA because the criteria for issuance is no longer met. 

 

Voluntary Improvement Program

 

FDA and the Medical Device Innovation Consortium (MDIC) continue to advance their pilot program launched in 2018. Select medical device manufacturing sites were chosen to review key business processes using a series of integrated best practices. The Capability Maturity Model Integration (CMMI) Institute certified select team to conduct and review quality system maturity of these sites.

 

Additionally, 2023 will likely bring even more data surrounding the MDIC program. This could include public info for industry about continuous improvement through quarterly check-in progress with participating medical device companies. The program is designed to report industry baseline metrics after the check-in and monitor operational excellence.

 

Breakthrough Devices Program

 

New information from FDA will arrive in 2023 for updates to the Breakthrough Devices Program. Early updates suggest the guidance will clarify how the program may be more applicable to certain devices than others. FDA breakthrough designation often benefits populations that are more likely to be impacted by health care disparities. New clarity may include breakthrough therapy designations and how medical device companies can educatee sponsors to submit for proposed indications of use. 

 

Finally, an important facet of the breakthrough devices program is the type of evidence needed for FDA approval. Clarity should help to determine whether a device is reasonably expected to increase the treatment or diagnosis efficacy. Moreover, early indications suggest that the intended use of the device, technology and features, and the available standard of care alternatives will all play a role.

 

About RCA’s Medical Device Consulting Services

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

 

  • SaMD Consulting
  • Threat Modeling
  • Proof of Concept
  • Quality Assurance Services
  • TIR 57 & TIR 97
  • ISO 62304
  • ISO 27001

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

 

Remediation Services

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

 

medical device consultingRegulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Audit & Internal Control

Posted on by Brandon Miller

While audits are not being conducted in the same way they were before the global pandemic, they continue to take place. New procedures adopted to deal with the coronavirus outbreak may have the unintended consequence of creating compliance gaps. An audit will identify these gaps so that you can address the issue. Understanding how the audit process has changed and what you may need to do differently can help your company navigate more smoothly.

 

Internal Control: What Processes Will Change?

 

Advance planning and proactive execution of your plan will put your company on track to conduct and complete internal, supplier and due diligence audits. Many of the processes you’re used to will change. Here’s how to prepare.

 

Auditboard: Did you Complete Advance Work?

 

You can complete some tasks off-site and in advance, such as reviewing standard operating procedures and the auditboard. You can also conduct teleconferences in advance to discuss any questions that will come up, or email ahead of time to find answers.

 

Certified Internal Auditor: Did you Hire an Expert?

 

Apply social distancing to the audit process by using video to substitute for certified internal auditor in-person visits when you can. Live streaming allows the certified internal auditor to view a facility instead of going there and possibly introducing new germs into the environment. Whenever possible, avoid walking around your employees during this process.

 

Acknowledge that the situation is not ideal. Giving auditors firsthand experience in your plant is preferable, but for the time being, it’s not always practical. Discuss what will happen to the tapes after the audit is over too so that your management team stays on the same page regarding disposal or preservation.

 

Audit Office: Are you Prepared for Virtual Interviews?

 

Interviews play a critical role in the audit process, and they will continue to serve auditors’ interests. Migrate audit office interviews to a virtual platform, and use teleconferencing apps to schedule and conduct them.

 

Audit Report: Increase the Transparency

 

The world has changed in a very short time due to the pandemic. This has led companies like yours to adopt new policies to curb the potential spread of COVID-19 or other infectious conditions. An audit offers the perfect opportunity to reexamine the audit report and increase the transparency of results. More departments and individuals should receive leeway to report deviations they see in the production process. Clarify your expectations for reporting in all aspects of production, including:

 

  • Manufacturing operations
  • Quality control
  • Compliance assurance
  • Supplier quality

 

Internal Control: Are you Building Trust?

 

Building trust with employees within a new internal control structure will put you on the path toward solving any audit issues uncovered. The goal of giving the public a reliable supply of needed products will become an achievable aim as a result. Continuing the audit process and running it smoothly is critical to public health. Companies must continue to uphold the supply chain for essential resources so that people receive the provisions they need.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

auditRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Biocompatibility Testing

Posted on by Brandon Miller

 

In this soundbite from RCA Radio, Dr. Helin Raagel and Dr. Matthew Jorgensen from Nelson Labs explain biocompatibility testing. This includes the risk-based biocompatibility evaluation that medical devices go through before they receive regulatory approval.

 

This biocompatibility risk-based approach evaluates the risk of the device through consideration of the device’s cytotoxicity, irritation, and sensitization. 

  • Cytotoxicity – Will the device kill or harm the cells it comes in contact with?
  • Irritation – Will the device make contact with the patient and cause skin irritation? (Redness and/or Swelling)
  • Sensitization – Will the device cause an allergic reaction?

 

Listen to the full episode “Intro to Pre-Clinical Testing and Biocompatibility” now!

 

About RCA’s Medical Device Consulting Services

 

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

 

  • SaMD Consulting
  • Threat Modeling
  • Proof of Concept
  • Quality Assurance Services
  • TIR 57 & TIR 97
  • ISO 62304
  • ISO 27001

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

 

Remediation Services

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

 

biocompatibility testingRegulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Data Integrity

Posted on by Brandon Miller

Data integrity is the reliability, consistency, and accuracy of data at rest and in transit. Quality data adheres to several standards, beginning with integrity, confidentiality and availability.

 

Data integrity is a process to ensure consistent and accurate data over its life cycle. Requirements specify that data records need to be attributable, legible, contemporaneous, original, and accurate (ALCOA). In addition to the ALCOA, there is ALCOA+ which also requires data to be complete, consistent, enduring, and available.

 

Good Practices for Data Management and Integrity

 

Compromised data can lead to poor business decisions. Any decisions based on inaccurate data are suspect during inspections. To ensure the integrity of your company’s data:

 

  • Implement access controls. Locking and securing sensitive records and restricting unauthorized users from accessing data can reduce loss and corruption. 
  • Make backups. Once lost, raw data is irreplaceable. Backups must include original, raw data creates a duplicate in an alternate location. 
  • Validate the data. Automate digital validation by organizing and filtering data using scripts. Validation checks the quality of the data to be secure, meaningful and correct. 
  • Have a quality system in place. Having a quality system in place and ensuring procedures can be completed on- or off-site will help solve any issues. 
  • Think through changes. If you’re going to change processes to adapt to a more virtual environment where employees work from home, think about all necessary steps or procedures.
  • Organize files and systems. Systemically arranging your files helps you easily pass off or explain data to others such as auditors and inspectors.
  • Validate input. You can use input validation to block cyberattacks, such as structured query language (SQL) injection prevention. Checking input at the time it is recorded is crucial.

 

Does your team need help with Data Integrity? Talk to our Experts→

 

New Guidance From the Food and Drug Administration (FDA)

 

The best way to maintain a supply of safe and effective products and prevent a drug shortage is to comply with data integrity concepts to prevent batch rejection/recall and monitor sites and stay up to date on FDA guidelines. You can do this by: 

 

  • Reviewing the staff manual guide. This guide covers FDA internal procedures for requesting records in advance of or in place of a drug inspection. 
  • Ensuring your company has a quality culture. Complications during the COVID-19 pandemic have only made processes more complicated, so establishing procedures around quality culture can help deter issues. 
  • Building quality into your operations: make sure you have a strong training program and it’s importance to the organization and the product.
  • Having a solid risk management plan. A solid risk management strategy can save you money, time, and unnecessary manufacturing disruptions and establish a process to deal with potential risks that may arise.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

FDA Harmonization

Posted on by Brandon Miller

The FDA harmonization team has recently announced it is no longer going to be a member of the Global Harmonization Working Party (GHWP). This comes as an eye-opener for many life science industry employees since FDA harmonization has been a visible priority since the agency joined GHWP in 2021.

 

The FDA stated that it will continue to work with global regulatory experts on international harmonization, with the primary partner being the International Medical Device Regulators Forum (IMDRF).

 

Food and Drug Administration

 

Some industry executives have asked the question why take this type of action now? One primary reason many life science industry experts believe the time is right is based on the Center for Devices and Radiological Health (CDRH) strategic plan launched in late 2023. Inside the details of the document, the Food and Drug authority laid out a four-year example timeline for working towards greater international harmonization.

 

These are a few of the initiatives listed to be achieved by FY 2027:

 

FDA Timeline

 

Each fiscal year, CDRH will now evaluate different types of opportunities to increase engagement across international harmonization programs. Further, it is anticipated that CDRH will receive additional funding and resources to help accelerate this engagement. These additional resources will be designed to allow the FDA to expand international harmonization and convergence programs already in progress. 

 

Best Practices

 

The second phase of the strategic plan is designed to increase discussions about the implementation of harmonized policies. Further, this new mechanism may require FDA to develop additional confidentiality agreements to increase the efficiency of research analysis & discussion under confidentiality commitments. CDRH will review the current list of approved regulatory partners and confidentiality protocols in place to align regulatory strategies across international agencies. 

 

Medical Research

 

Per the strategic plan, FDA will identify and begin engaging with regulatory authorities by the end of 2023. The primary objective is to create a database of regulatory bodies with whom sharing medical research could be most helpful toward the global harmonization of standards. Finally, CDRH has committed to creating this information-sharing mechanism to communicate best practices in medical device evaluation by the end of 2024. 

 

Technical Documents

 

The strategic plan goes on to elaborate on how CDRH’s regulatory policy compares to widely accepted IMDRF policies. Furthermore, technical specifications of IMDRF documents that include policies and practices approved by all regulatory authorities in the IMDRF Management Committee will be assessed and evaluated by FDA.

 

One goal of this regulatory process is to increase the understanding of technical description and technical report writing of international regulatory agencies. This will directly help CDRH with their internal assessment of international harmonization efforts, and how FDA’s process may differ in comparison to regulators around the world.

 

FDA Analysis

 

Based on the technical specification data listed in the strategic plan, these are the proposed timelines for CDRH to make advances toward global harmonization:

 

  • CDRH will publish an assessment of at least nine IMDRF technical documents by the end of 2025.
  • CDRH will publish an assessment of at least 18 IMDRF technical documents by the end of FY 2026.
  • CDRH will publish an assessment of all remaining IMDRF technical documents by the end of FY 2027

 

Regulatory Authority

 

The strategic plan continues to elaborate on the life science community and the impact non-FDA employees can have on future regulatory approval. These specific stakeholders may have a unique perspective based on their current occupation or the types of therapy a patient receives. Finally, the following audiences are specifically mentioned for providing first-hand experiences that FDA can leverage based on another regulatory authority’s approach to medical therapy. 

 

  • Healthcare patients
  • Life science manufacturers
  • Conformity assessment bodies
  • Standards development organizations

 

Patient Engagement

 

Finally, an annual communication plan is proposed to begin in 2024 that includes developing a forum to assess and report on harmonization program efforts in progress. This forum will be designed to connect with each of the audiences mentioned above to help FDA identify opportunities for learning. Furthermore, this forum would be dependent on the level of interest and considerations of other stakeholders, including the life sciences industry specifically. 

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

fda harmonizationRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Quality Assurance Services

Posted on by Brandon Miller

About RCA’s Quality Assurance Services

In the life science industry, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device or drug is sent to market. At Regulatory Compliance Associates (RCA), we offer you the quality assurance services you need to monitor these quality processes and ensure quality compliance every step of the way.

 

RCA’s quality assurance services include quality system assessments, strategy, implementations, and identification of quality metrics. Our quality consultant projects are designed to ensure continuous improvement and align with your business needs & goals. Our quality consultants are quality experts with experience spanning major corporations and start-ups. Our quality management consultant team knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

Follow the links below to learn more about our quality assurance services in Pharmaceuticals and Medical Devices. 

 

Pharmaceuticals

Medical Device

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].