Author: Anne Holland, CEO and Founder
Navigating the New Quality Management System Regulation: Insights from Our Latest White Paper
We are excited to announce the release of our comprehensive white paper that delves into the FDA’s newly finalized Quality Management System Regulation (QMSR), effective February 2, 2026. This pivotal regulation, which integrates ISO 13485 standards, aims to simplify and harmonize quality management for medical device manufacturers. Our latest white paper breaks down the significant changes introduced by the QMSR, including enhanced transparency in FDA inspections, a streamlined approach to risk management, and a shift towards terminology that aligns with international standards.
Download the QMSR white paper now.
As the medical device landscape evolves, so too must the strategies for compliance. The QMSR not only presents opportunities for improved efficiency but also challenges that manufacturers need to address. Our white paper offers actionable insights on preparing for the transition, including conducting gap analyses and embedding a robust risk management framework. By equipping yourself with the knowledge in our white paper, you can better navigate these regulatory changes and position your organization for success in a global market. Don’t miss out—read our white paper and schedule a discovery call with us to stay ahead of the curve!
