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Medical Device Needs and Requirements

Presentation gave at the INCOSE RWG October 15 Monthly meeting by Lou Wheatcraft. The presentation's purpose is to map the underlying product development process described in the US FDA Title 21, Part 820 and ISO 13485 Quality Management to the concepts and activities in the INCOSE RWG Needs and Requirements Manual (NRM) to be published by Wiley in November 2024. This presentation is a precursor to the development of a Guide to Medical Device Needs and Requirement to be developed by the Requirements WG and Medical Device WG.