Technical Documentation and MDR Audits: How to Prevent Critical Non-Conformities
1. OVERVIEW
This Whitepaper is a practical guide designed to support medical device manufacturers in the proper preparation of Technical Documentation (TD) in accordance with Regulation (EU) 2017/745 (MDR). Through an operational and compliance-oriented approach, the whitepaper provides guidance on how to structure, organize, and maintain robust, consistent, and compliant Technical Documentation. […]
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