IMDRF · International guidance
IMDRF/PMD WG/N74:2023
Personalized Medical Devices - Production Verification and Validation
International Medical Device Regulators ForumIMDRFTechnical guidance
International guidance
This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.
Source identity
- Issuing body
- IMDRF
- Reference
- IMDRF/PMD WG/N74:2023
- Published (source metadata)
- April 11, 2023
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About this guidance
Personalized Medical Devices - Production Verification and Validation
Production verification and validation requirements for personalized medical devices. Addresses unique V&V challenges for custom and patient-matched devices.