Module 14: Design Development and Certification of Medical Devices

22/11/2023

MDR Technical Documentation Submissions Common Issues – Design & Development Data

James Newman, Global Training Manager BSI Regulatory Services

The Organisation for Professionals in Regulatory Affairs

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The most common reasons for delays in technical documentation reviews are:

● Incomplete Submissions - all the information needed for the review not provided

● Poor Structuring of Documentation – information present but difficult to locate.

The Organisation for Professionals in Regulatory Affairs

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