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Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

Why Your Regulatory Strategy Can't Ignore Medical Electrical Standards & Guidances

Leo Eisner (Principal Product Safety and Regulatory Consultant , Eisner Safety Consultants)

Location: 210D

Date: Wednesday, February 6

Time: 3:15pm - 5:30pm

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

Regulatory requirements drive the use of certain standards & regulatory guidances in circuits and systems design for medical devices. In this session, you’ll get the resources you need to keep track of recent changes and those in development for medical electrical standards and regulatory guidances, for the United States, Canada, and EU.

Topics covered include:
  • The IEC 60601 series structure - why do all those dashes matter?
  • An analysis of the medical electrical and related standards that have been recently updated or are in development, and how these standards interact with each other
  • IEC 60601-1 and its collaterals (IEC 60601-1-XX standards) are going thru another set of changes - what are some of the impacts?
  • What are the plans for aligning the particular standards (IEC 60601-2-XX & IEC/ISO 80601-2-XX) with the general (IEC 60601-1) and collateral standards in the 60601 series?
  • Related standards that are in the process of change: ISO 14971, IEC 62366-1, and IEC 62304
  • Standards and guidances inputs to your regulatory strategy (and product development plans) that need to be relayed to your regulatory, design and product development team members

Presentation File

Why_Your_Regulatory_Strategy_Cant_Ignore_Medical_Electrical_Standards__Guidances.pptx