Aligning Your QMS with the FDA's QMSR Updates

In February 2026, the FDA new Quality Management System Regulation (QMSR) will become effective. This represents the most significant change since the implementation of design controls in 1996 and is aimed at aligning the U.S. regulations more closely with global standards, particularly ISO 13485.

What does this mean for manufacturers and why is it vital to get ahead of it?

Join us for an insightful 45-minute webinar (including Q&A) where RQM+ Vice President of Intelligence & Innovation, Nancy Morrison, RAC will dive into the upcoming changes. Understand the critical updates, from design controls and risk management to traceability and record-keeping requirements. Discover how these changes aim to streamline processes, enhance device safety and performance, and foster a more global alignment in quality management practices.

Whether your organization is currently ISO 13485 compliant or facing a significant overhaul of your quality management system (QMS), our session is designed to provide you with the knowledge and strategies to assess the impact, plan effectively, and implement the necessary changes efficiently. We'll also explore the unchanged elements of the regulations to give you a comprehensive understanding of the landscape post-2026.

By attending, you'll gain:

• A clear understanding of the new QMSR requirements and their implications for your business.
• Insight into how to compare your current QMS with the revised requirements and identify key areas for action.
• Strategies for quality planning, executing updates, and ensuring compliance through practical examples and expert guidance.
• Opportunities to ask your questions and interact with industry peers facing similar challenges in the webinar chat.

Don't miss out on this opportunity to prepare your team for a smooth transition to the new regulatory environment, ensuring continued compliance, and maintaining the highest standards of quality and safety for your medical devices.

Please complete the form to watch the recording and download the slides.

Presenter

Nancy Morrison, RAC
Vice President, Intelligence & Innovation

Nancy has over 30 years of quality and regulatory experience in the medical industry with US and global regulatory submission experience. The last eleven years have been with RQM+ working with start-up, mid-size, and multi-national medical device and combination product companies. Nancy has a Bachelor of Science in Mathematics and an Advanced Certificate in Regulatory Affairs along with RAC certifications for the US and EU. Nancy has been providing FDA, EU MDR, and IVDR leadership in developing solutions and implementing the regulations at small and large organizations.

Melissa DeHass
Principal Consultant

Melissa holds a BSc in Biology, a certificate in Regulatory Compliance, and an MBA. She has worked for over 20 years in medical devices and pharmaceuticals. Melissa has worked across the product life cycle, from development to post-market. She has proven cross-functional experience and uses this skillset to support new product development and assess design changes from regulatory and quality perspectives. She has written regulatory strategies, 510(k)s, a PMA supplement, NDA supplements, a breakthrough designation and technical files. She has experience with QMS development and improvement, and with supporting a company through ISO certification. Melissa is a certified internal lead auditor and has conducted internal and supplier audits as well as hosted FDA and Notified Body audits. Through her experiences working for small medical device manufacturers, Melissa takes a business-balanced approach to regulatory and quality.