FDA goes 13485 – say hello to QMSR!

Finally! On January 31, 2024, the FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference, ISO 13485:2016. Medical devices – Quality management systems The final decision was presented four years after […]

2024 To-Do list for legacy devices transitioning to MDR

The European Commission published Regulation (EU) 2023/607 in early 2023 which specifies conditions for extending the deadlines for medical device manufacturers transitioning from MDD to MDR and removing the “sell off” period. The regulation was published to minimize impact on healthcare services caused by device shortage, to prevent unnecessary disposal of safe devices and to […]

Navigating Medical Device Regulations – Insights from Our Danish Consultants

Cecilie Bengtsen, Mia Trustrup Larsen, and Nadia Ragnvald Caspersen Key2Compliance has in the past two years expanded its Nordic presence with a dedicated team of regulatory compliance consultants in Denmark. The expansion is timely, given the increasingly stringent compliance requirements for medical devices introduced by the Medical Device Regulation (MDR) and the In Vitro Diagnostic […]

IEC 60601 – Meeting the Electrical Safety Standards of Medical Devices

IEC 60601 Electrical safety regulatory compliance

Read and learn more about IEC 60601 and IEC 61010, and the factors you should consider when developing a regulatory-compliant medical device.  Electrical devices are part of our everyday lives, and they are undoubtedly cornerstones of our society and technology – this applies to the industries of life sciences and medical technology as well. However, […]