Whether it’s a corporate needs analysis, corporate growth/transformation initiative or due diligence/acquisition, Regulatory Compliance Associates (RCA®) worldwide experience can help ensure a successful mix of top-notch advice and people so your strategy is on time, and on budget — and you’re never embroiled in a costly mistake.
Follow the links below to learn more about our strategic consulting services in Pharmaceuticals and Medical Devices.
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Regulatory Compliance Associates has significant quality and regulatory compliance consulting experience and a proven regulatory framework for managing FDA 483’s, Warning Letters, and Consent Decrees. Our pharmaceutical consultants know how to partner with executive, legal, and communication teams at all levels of a life science company. RCA’s remediation consulting experts can assist your management with a remediation strategy that is accepted by the regulatory agency and realistic to execute internally. Finally, RCA can partner with your leadership team to develop a long-term risk management plan to help your team stay in compliance going forward.
Regulatory Compliance Associates can assist with answering FDA 483 observations, FDA Warning Letters and developing strategies to help your organization maintain regulatory compliance through continuous improvement.
RCA can help with remediation activities in both manufacturing operations & quality management systems. RCA’s regulatory consultants have completed many projects assisting our clients to evaluate what is needed, collaboratively determine action plans & help execute. We have also performed post-implementation audits to ensure regulatory compliance.
Follow the links below to learn more about our remediation services in Pharmaceuticals and Medical Devices.
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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 or developing a response to an FDA finding, Regulatory Compliance Associates® team of compliance consultants can help. Our business consultant Experts are internationally known in the regulatory compliance consulting industry.
The regulations process surrounding life science companies can be tricky for even the most experienced compliance veteran. If you’re consistently unable to comply with regulations, any notified body can deliver devastating consequences for your business. At RCA®, we offer the management consulting resources necessary to guide you in regulatory compliance.
Follow the links below to learn more about our compliance assurance services in Pharmaceuticals and Medical Devices.
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The FDA recently released a final guidance on regulating AI-enabled medical devices that focuses on how manufacturers can modify these devices after they are authorized. The agency introduced a new regulatory framework called pre-determined change control plans (PCCPs), which allows certain post-market changes to devices using AI or machine learning. PCCPs were first mentioned in a 2019 discussion paper, and the FDA has since issued draft and final guidance on them.
This final guidance outlines the required information for PCCPs, which includes;
Manufacturers can propose updates to AI models, such as re-training to improve accuracy, without needing new submissions, as long as the changes stay within the device’s intended use. However, significant modifications outside the scope of the PCCP, like altering a device’s function or user base, would require new FDA submissions.
Premarket authorization for AI-enabled devices with a PCCP must be established through the PMA pathway, 510(k) pathway, or De Novo pathway as a PCCP must be reviewed and established as part of a marketing authorization.
Follow the link to learn more about RCA’s Medical Device Product Approval Support and Submission Services.
Join Regulatory Compliance Associates (RCA) at the annual Utah Life Science Summit in Salt Lake City November 14th. Anita Michaels, RCA’s Executive Pharma Compliance Expert & Principal Consultant, and Jordan Elder, RCA’s Director of Regulatory Affairs, will be presenting with Thor Rollins, VP, Global Segment Leader of Medical Devices at Nelson Labs, on Navigating the FDA’s Medical Device Presubmission Process.
This presentation provides a comprehensive overview of the FDA’s medical device presubmission process, a critical step for manufacturers seeking to efficiently bring safe and effective devices to market. This session will examine the strategic advantages of utilizing the presubmission program (Q-Sub), outlining key components and benefits.
This presentation is essential for medical device manufacturers, regulatory professionals, researchers, and anyone involved in developing and commercializing medical devices in the United States. Attendees will better understand how to leverage the presubmission process to their advantage, ultimately accelerating their product’s journey to market.
Immerse yourself in a dynamic environment where industry leaders and professionals come together to network, exchange ideas, and gain valuable insights into the latest trends shaping the future of life sciences in Utah. Explore a diverse range of exhibitors showcasing cutting-edge technologies and innovations, participate in engaging panel discussions on key industry issues and business development strategies, and hear from top-notch speakers offering in-depth analysis and expert perspectives on the current state of the life sciences sector in the region. Don’t miss this unparalleled opportunity to connect with like-minded colleagues, learn from industry experts, and stay ahead of the curve in the ever-evolving world of life sciences. Click here for the full agenda.
Join Regulatory Compliance Associates (RCA) along with our colleagues from Nelson Labs and Sterigenics as we will be exhibiting at this year’s BIOMEDevice Silicon Valley expo in Santa Clara, California. Visit us in booth # 1042 to connect with experts from each of our teams to learn how we can provide you with a complete solution for any of your projects. Together we understand your business and are prepared to discuss solutions to your regulatory, quality, compliance, sterilization, and lab testing needs to help ensure the safety of your product and process.
From digital health to surgical robotics, BIOMEDevice is the starting point for the discovery of progressive solutions to challenges and impactful products. We bring together engineers, business leaders, disruptive companies and innovative thinkers from the top start-ups and medical device OEMs together to inspire and collaborate on the next lifechanging medical device. Our community comes together in Silicon Valley the #1 MedTech hub in the country to share new innovations, educate each other on what’s new in the industry, collaborate on new ideas, and partner to move the industry forward.
