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Informational ISO 13485:2016 under systematic review

#1
As can be seen in the ISO 13485:2016 page on the ISO website – the standard is under systematic review.

Systematic review is required for each standard and deliverable from ISO. It helps in keeping the documents up-to-date. Usually, the systematic review is performed every 5 years, but due to some concerns, the systematic review of ISO 13485:2016 was agreed to be in 3 years.

To understand the systematic review process, ISO created a guide – Guidance on the Systematic Review process in ISO.

To participate in the systematic review process, you need to go to your National Committee and verify how they are participating in the process.

Posted at Marcelo's Medicaldevice.expert website...

You may comment and discuss in this discussion thread.
 
#3
A lot, in fact! On the other hand, there are dozens of statements from NCs and related organizations to not use the HLS because of the regulatory use of ISO 13485 (for example, as a basis for the MDSAp program).
 
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