Activity

  • thuytienlecao replied to the topic FDA Considering Updating Quality System Requirements in the forum Quality Systems Management 6 years, 12 months ago

    Thanks for the article and info @alexandrabuga. I agree that it is logical. And it would make things simpler. Other than the points from @kak33 comment, in comparison with ISO 13485, FDA 21 CFR Part 820 QSR is the law for medical device companies manufacturing and selling products for the US market. So I don’t think QSR would be replaced completely. And I think the article mentioned that QSR will (possibly) include parts of ISO 13485, not the other way around to replace QSR standards.