Harmonizing Quality Systems: FDA ISO 13485

Event Time

Originally Aired - Thursday, November 4 10:15 AM - 11:00 AM

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Event Location

Location: MedTech Central Theater (Booth 2049)

Event Information

Title: Harmonizing Quality Systems: FDA ISO 13485

Event Type: Session

Badge Type: 2-Day Pass,1-Day Pass,Expo Pass


21CFR820 was already well behind ISO 13485:2016 with regards to including risk based assessment throughout quality. With the update to ISO 14971 in 2019 and the release of ISO/TR 24971 in 2020, this gap has grown ever more apparent. This presentation will go over the best ways to integrate a risk management approach not just in projects, but over the whole quality system including management review, supplier management, training effectiveness, document control and in-process monitoring. Special emphasis will be placed on usability, post-market surveillance and resisudal risk as those are new areas of emphasis in ISO 14971:2019.