A year after the publication of ISO 11607-1/2 revisions, seeking further harmony with 2020’s EU MDR, new changes are in the works.
It’s not news that review of ISO standards for medical device development is perpetual. Not only does this keep the folks at ISO busy, it keeps those of us adhering to the standards on our toes, too. For the last year, there has been plenty of discussion of changes to ISO 11607 Parts 1 and 2.
Full Article on ISO 11607-2 Risk Management