New EU Implementing Regulation Introduces Greater Predictability for Conformity Assessment
The European Commission has adopted Implementing Regulation (EU) 2026/977, introducing new conformity assessment requirements for notified bodies under the MDR and IVDR.
Swissmedic Updates CAPA Plan Content Requirements for Medical Devices
Swissmedic publishes updated CAPA plan requirements for medical devices, effective April 2026. Key impacts for manufacturers and compliance strategies explained.
FDA Draft Guidance Aligns QMS Requirements with ISO 13485: What It Means for Medical Device Manufacturers
The FDA has released a draft guidance aligning U.S. Quality Management System (QMS) requirements with ISO 13485:2016. This change simplifies compliance for medical device and IVD manufacturers and distributors, ensuring global harmonization and streamlined FDA premarket submissions effective February 2026.