The new ISO/TR 24971, “Medical devices – Guidance on the application of ISO 14971,” has been released. The ISO/TR 24971 was written to address the difficulties that some folks have in implementing particular clauses of the ISO 14971. It supplements the guidance already found in the ISO 14971, so if you’re using that ISO standard you may want to get a copy of this new Technical Report.
Guidance on the following particular areas are addressed in the new Technical Report:
- The role of international product safety and process standards in risk management,
- Policy development for risk acceptability criteria,
- Integrating production and post-production feedback loops into risk management,
- How to differentiate information for safety as a risk control measure vs. the disclosure of residual risk, and
- Evaluation of overall residual risk.
ISO/TR 24971 also suggests some alternative approaches for implementing and maintaining a risk management system for ISO 14971.
All this stems from the fact that the use of ISO 14971 sets a acceptable risk threshold for hazards and hazardous situations unless there is objective evidence to the contrary. This means a medical device company has to document how they identified those hazards/hazardous situations and also monitor potential “evidence to the contrary.”
ISO/TR 24971 provides the user with 12 pages of detailed questions to review, decision flow charts, and discussions of the factors listed above. It will surely assist medical device manufacturers meet the issues recently identified in the informational annexes of the European adoptions of ISO 14971.
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If you’re in the Medical Device business, you need to know about the changes to the standards you use. But you also need to know about new releases like the ISO/TR 24971. That’s why you should be using Document Center — We’re Your Standards Experts!
