Regulatory Open Forum

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 the IEC 60601 series (IEC 60601-X-YY / IEC/ISO 80601-2-YY), 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 <g class="gr_ gr_41 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins replaceWithoutSep" id="41" data-gr-id="41">success</g> of global harmonization.
This webinar is being co-presented by me, Leo Eisner, the "IEC 60601 Guy", founder and principal regulatory & product safety consultant at Eisner Safety Consultants, along with Captain Scott Colburn and Gail Rodriguez of the FDA, and moderated by Jon Speer of Greenlight Guru.

See Eisner Safety Consultants Blog post for further details

• Overview of IMDRF
• IMDRF's forthcoming guidance "Optimizing Standards for Regulatory Use"
• <g class="gr_ gr_44 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins doubleReplace replaceWithoutSep" id="44" data-gr-id="44">Key</g> concept of the Essential Principles of Safety & Performance
• <g class="gr_ gr_45 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins replaceWithoutSep" id="45" data-gr-id="45">Concept</g> of Essential Performance in IEC 60601 standards for medical electrical equipment and how it relates to the Essential Principles
• Upcoming major changes and revisions to the IEC 60601 series

• Medical Device Industry Executives
• Regulatory Affairs Professionals and Management
• Quality Professionals and Management
• Clinical Affairs Professionals and Management
• R&D Engineers and Management
• Regulators
• Standards Development Organizations and Standards Developers
• Test Labs
• Accreditors