Standards are a key priority for The International Medical Device Regulators Forum (IMDRF).
Its forthcoming guidance, “Optimizing Standards for Regulatory Use," encourages the development of ‘regulatory ready’ standards, including direction to Standards Development Organizations (SDOs) to consider medical device ‘essential principles’ when writing standards.
This webinar will introduce viewers to IMDRF, review this upcoming guidance, and discuss the role IMDRF and its priorities play in relation to international medical electrical equipment standards in IEC 60601-1 series, proposed IEC 60601 series updates, and significant changes planned for the draft IEC 60601-1 Ed3.2.
Finally, it will summarize why standards conformity assessment is critical to ensure success of global harmonization.
Medical Device Industry Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
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