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5 Key Changes in ISO 14971:2019

5 Key Changes in ISO 14971:2019

The third edition of ISO 14971, just published, aims to clarify requirements and improve effectiveness of medical device risk management.

Regulatory ComplianceNaveen AgarwalJanuary 14, 2020ISO 14971, ISO 14971:2019, Medical Device Risk Management, Understanding ISO 14971:2019, FDA Risk Requirements, Quality Management System, risk management planComment