The 3rd Edition of the Medical Device Risk Management standard, ISO 14971:2019, was approved May 2019 and replaces the second edition (ISO 14971:2007).
Key Changes Include:
- Additional requirements of the Risk Management Plan.
- Clarification to reasonably foreseeable misuse considerations.
- Addition of a requirement for hazardous situations to be considered and documented.
- Addition of a requirement for disclosure of residual risks.
- Clarification to information collection requirements in production and post-production
For discussion on each of the changes, check out our full article.