Tag: ISO 13485

FDA ISO13485 Harmonization

Posted on by Brandon Miller

Click now to hear from Jordan Elder, RCA’s Director of Regulatory Affairs, regarding the latest info on Quality System Regulation (QSR) regulations and FDA harmonization efforts:

 

 

When developing a quality management system (QMS), it is important to understand any pitfalls that could arise as well as understand what each notified body looks for in a compliant quality system. Recently, one of the US Food and Drug Administration’s (FDA’s) top medical device regulators said harmonizing the agency’s current Quality System Regulation with the International Organization for Standardization (ISO) 13485:2016 is a “high priority”.

 

Click to learn about the latest updates to the QMSR File Rule.

 

QMS Harmonization

 

Currently, the US Food and Drug Administration (FDA) does not enforce ISO’s 13458:2016 standards set in place for Quality Management Systems, but uses its own Quality System Regulation (QSR) guidelines that do include parts of the 13458 standards. But this is set to change for the better. The FDA has recently proposed plans to align its quality system requirements with ISO 13485:2016, creating a new regulation dubbed the Quality Management System Regulation (QMRS). This shift came four years after the agency first proposed the regulatory alignment.

 

Quality Management System

 

Manufacturers who already conform to the ISO standard should not see much change and this move should help create efficiencies for them in the long run. The FDA proposed the alinement by incorporating the 2016 edition of the international standard specific for medical device quality management systems ISO13485. Through this rulemaking, the FDA is also proposing additional requirements that help connect and align ISO13485 with existing requirements in the FD&C Act and its implementing regulations. This will include making conforming edits to 21 CFR Part 4 to clarify the device CGMP requirements for combination products as well.

 

Risk Management

 

The most noticeable difference between the current quality systems regulation and ISO13485 is that the risk management requirements are integrated throughout the aspects of the quality management system in ISO13485. This differs from 21 CFR 820, in that the only risk-specific requirement in the QS regulation is listed in §820.30(g), as it relates to risk analysis as a part of design validation.

 

These revisions are intended to supplant the existing ISO13485 requirements with the specifications of an international consensus standard for medical device manufacturers. The revisions are expected to reduce device manufacturers’ burdens, specifically aspects of compliance and recordkeeping through the harmonization of domestic and international requirements.

 

ISO Standard

 

With a membership of 168 national standards bodies, ISO is an independent, non-governmental international organization that brings together experts from around the world to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges.

 

Although the standers set by ISO are recognized by organizations around the world, ISO compliance itself isn’t a legal requirement, the standards naturally align with different regulations across the industries. ISO compliance means using ISO standards as guidelines for aligning your policies, processes, and operating procedures to adhere to the standard.

 

ISO 13485:2016

 

ISO 13485:2016 specifies requirements for medical device quality management systems where an organization needs to demonstrate its ability to consistently meet customer and applicable regulatory requirements. This includes one or more stages of the product life cycle, including:

 

  • Design controls and development
  • Production and manufacturing
  • Storage and distribution
  • Installation
  • Servicing a medical device
  • Technical support

 

ISO13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.

 

 

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. 

 

Medical Device cGMP & QMSR

Posted on by Brandon Miller

The FDA recently issued the Final Rule for the Quality Management System Regulation (QMSR) that amends the current medical device cGMP requirements of the Quality System (QS) regulation (21 CFR 820).

 

The FDA over the last few years has been looking to harmonize its medical device CGMP regulatory compliance and this action continues its efforts to align with other regulatory authorities to promote consistency in the regulation of devices and provide a timelier introduction of safe, effective, high-quality devices for patients.

 

Effective February 2, 2026, two years after the publication of the final rule, FDA will begin to enforce the QMSR requirements upon the effective date. Until then, manufacturers are required to comply with the QS regulation.

 

What is Changing?

Title: The new rule amends the title of the regulation. The revised part 820 will be referred to as the Quality Management System Regulation (QMSR).

 

Requirements: 21 CFR 820 has been amended by incorporating the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. The FDA implemented this final ruling to promote consistency in the regulation of medical devices.

 

Additionally, the rule establishes more requirements that clarify certain expectations and certain concepts used in ISO 13485 to mitigate inconsistencies with other applicable FDA requirements. FDA has also made conforming edits to part 4 (21 CFR part 4) to clarify the device Quality Management System (QMS) requirements for combination products.  These edits do not impact the CGMP requirements for combination products.

FDA’s FAQ’s

 

 

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Impact of QMS on Quality Maturity

Posted on by Brandon Miller

In an interview with Pharmaceutical Technology®, Susan Schniepp, distinguished fellow, Regulatory Compliance Associates®, and co-chair of board of directors, Parenteral Drug Association, expands on the importance of maintaining a robust quality management system (QMS) in bio/pharmaceutical manufacturing. 

 

For advanced therapy medicinal products (ATMPs) in particular, Schniepp emphasizes how fast-moving this sector is. “The regulations don’t keep up with the ATMPs. That technology, and their way of thinking, is turning over quicker than the regulatory standards,” she says.

 

Follow the link to watch the free video here

 

“The changes in the regulations that are going to come are going to be around quality culture and maintaining a robust quality management system,” she adds. Ensuring documentation and keeping equipment calibrated are important practices to apply to these new fast-moving ATMPs, she states. Schniepp does not necessarily expect to see many changes in the regulations around ATMP development and manufacturing but thinks that there will likely be more guidance documents issued in the future, with one of FDA’s focuses being its quality management maturity model.

 

“There are some regulations out there that call out quality culture. In particular, the World Health Organization has one on data integrity. It has a definition and standard[s] on what quality culture is,” Schniepp says. She points out that a new aspect of her presentation at INTERPHEX this year is its interactive component, in which she sets up a scenario involving an internal audit where an incident occurs. She gives the audience three potential responses to discuss, but rather than simply asking them which response do they pick or which response is correct, she instead asks what does the chosen response say about that person or that company’s QMS and the maturity of that system?

 

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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].