The Medical Devices Introductory Course 2020

BS EN ISO 14971: Overview of structure and contents

ALL risks to be reduced as far as possible

The Organisation for Professionals in Regulatory Affairs

BS EN ISO 14971: Overview of structure and contents

Risk control option analysis (Clause 7.1)

Implementation of risk control measures (Clause 7.2)

Residual risk evaluation (Clause 7.3)

Benefit-risk analysis (Clause 7.4)

Risk Management File

Risks arising from risk control measures (Clause 7.5)

Completeness of risk control (Clause 7.6)

The Organisation for Professionals in Regulatory Affairs