Template Updates Q4-2024 #49
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14971:2019 changed from ALARP to ALAP -> therefore, remove any yellow fields (not green)
Rationale why RMP may be updated sooner than end of PMCF cycle.
Annex C provides examples that should be considered for a first-time risk analysis of a device documentation.
TÜV Rheinland finding from TD review
- Updated harmonized norms - Added guidance papers - Added references to TD records
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