Regulatory affairs strategy consultant at SQR Consulting
< 1 min reading time
The DIS (Draft International Standard) of the review of ISO 14971 – Health Product Risk Management – should be circulated to national committees soon. The ballot will remain open until mid-October.
It is extremely important for those involved to review and comment on the text, as this is the last chance for technical modifications to the project – if draft is accepted, technical requirements can no longer be modified until publication.
For each country, the availability of the document (which is copyrighted and not for open circulation) and means to comment depends on how the country deals with mirror groups to ISO TC 210 or ISO TC 210 JWG 1. Usually, there’s a national mirror group that deals with the international work. Please inquiry at your National Committee organization.
In Brazil, the document is handled by WG 2 – Risk Management – from EC 26: 150.01 of ABNT CB 26. WG 2 members will receive and review the document.
The WG will also hold an open meeting for those interested to take note of the text and assist in creating the Brazilian comments. This meeting will be scheduled shortly.
Marked as spam
Meet your next client here. Join our medical devices group community.
Please log in to post questions.