2 docs tagged with "risk-management"

A detailed examination of the six general Essential Requirements in Section I of Schedule 1 of the UK Medical Devices Regulations 2002 — the safety, performance, risk management, and design principles that apply to every medical device placed on the GB market.

How to apply ISO 14971 risk management to satisfy Essential Requirement 2 of the UK MDR 2002 — the risk management plan, hazard identification, risk estimation, risk controls, residual risk evaluation, and the lifecycle requirement to keep the risk file updated.