TÜV Rheinland — Risk Management for Medical Devices: ISO 14971:2019
Summary
TÜV Rheinland guidance on applying ISO 14971:2019 risk management in the context of EU MDR requirements. Covers risk analysis, risk evaluation, risk control, and benefit-risk assessment methodologies for medical device manufacturers.
Document Details
Document IDTUVR-RISK-MGMT
TypeWhite Paper
AuthorityTÜV Rheinland (NB 0197)
Publication Date2023-04-01