On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy for Low Risk Devices (the General Wellness Guidance) and Clinical Decision ...

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.

Economic Competitiveness and U.S. Policy compiles all eight Progress Reports and Scorecards from CFR’s Renewing America ...

The U.S. Food and Drug Administration may soon convert an entire generation of U.S. children, especially children in foster ...

The U.S. FDA’s Jan. 14 webinar for the new Quality Management System Regulation included some fairly predictable content, but one member of the FDA staff mentioned that the agency now expects ...

The EU MDCG 2025-10 Guidance on Post-Market Surveillance of Medical Devices and In Vitro Diagnostic Medical Devices (Dec 2025) provides manufacturers with detailed interpretations of MDR and IVDR PMS ...

With over 50 years of direct experience with the FDA, RQM+ provides regulatory affairs and quality assurance solutions for MedTech that assist innovators in achieving and sustaining global compliance.

The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation (MDR) and the FDA’s Quality Management System Regulation (QMSR) setting new ...

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 ...

The Food and Drug Administration issued a warning letter to Philips citing significant violations at three of its medical device facilities. The inspections took place between January and March 2025 ...

AI-powered gap analysis, continuous compliance monitoring, real-time visibility, and pre-built life sciences frameworks help organizations reduce audit preparation from months to days, accelerate ...