Use of International Standards in Medical Device Regulation

This training program “Use of International Standards in Medical Device Regulation” offered a concise overview of how international standards can enhance regulatory frameworks and support efficient, risk-based oversight.

 The separate presentations built on key concepts from recent IMDRF trainings, explained practical approaches to using standards—including IMDRF N51—and highlighted examples. The session also introduced how standards contribute to regulatory reliance and featured real-world applications of widely used standards such as ISO 13485. 

These materials summarize the key insights shared with participants and are made available here for broader reference. 

The lectures were delivered by major regulatory authorities and experiences industry representatives.