Posts tagged risk management plan

Clause 4.2 of ISO 14971:2019 requires the top management to define and document a policy for establishing criteria for risk acceptability. This policy must provide a framework to ensure that criteria are based on applicable national or regional regulations and relevant International Standards, stakeholder concerns and generally acknowledged state of the art.

Risk ManagementNaveen AgarwalAugust 26, 2020ISO 14971 Basic Concepts, ISO 14971:2019, ISO 14971, Understanding ISO 14971:2019, understanding risk management, risk management plan, risk management policy, policy, risk management, risk management videoComment

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.