Posts tagged understanding risk management

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.

Understanding Risk Management Requirements in ISO 13485:2016

The current revision of ISO 13485:2016 has new requirements for risk management. Here are some questions to consider and guidance for implementation.