On January 31st, 2024, the medical device industry achieved a significant milestone when the FDA updated the Quality System (QS) Regulation to the Quality Management System Regulation (QMSR). This amendment, integrating the ISO 13485:2016 standards, represents an important move towards global regulatory harmonization. By aligning U.S. regulations with international standards, we are advancing towards a unified framework that enhances the safety, effectiveness, and compliance of medical devices globally.
This harmonization opens up opportunities for streamlined international operations and provides an easier path for European companies to access the U.S. market. It also underscores the importance of meticulous preparation and transition to the new requirements.
With the rule set to become effective on February 2nd, 2026, medical device manufacturers have a crucial window of opportunity to align their systems, processes, and training with these new standards. Although FDA inspections before the effective date will still adhere to the QSR, we strongly encourage our clients to optimally use this time to prepare for the transition.
Our recommendation is to start evaluating your current quality management systems for alignment with ISO 13485:2016 now. With our support, you can achieve a quality management system that not only meets all requirements but also adds value to your company by leveraging the benefits of global regulatory harmonization.
Having a clear roadmap to navigate the EU Medical Device Regulations or the FDA’s requirements ensures your certification journey will be smooth and successful. Our expertise is proven, having successfully developed and optimized QMS for manufacturers worldwide.
