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Tech Talk Panel: FDA’s Shift from 21 CFR 820 Toward ISO 13485: How It Will Impact You

Wil Vargas  (Director, Standards, AAMI)

Kim Trautman  (Executive Vice President, Medical Device International Services, NSF International)

Mark Swanson  (Principal Consultant, H&M Consulting Group, LLC)

Lena Cordie-Bancroft  (Owner/Principal Consultant, Qualitas Professional Services, LLC)

Matt Graf  (Director, Quality Assurance & Global Quality Systems , Cook Medical)

Location: 210D

Date: Wednesday, February 12

Time: 8:30 am - 9:30 am

Track: MD&M Conference: Understanding the Impact of Recent Changes to Quality Standards (in partnership with AAMI)

Vault Recording: TBD

FDA has formally announced its intention to revise the Quality Systems Regulation in 21 CFR 820 to converge closer to ISO 13485:2016. This will affect the regulatory requirements in the US as well as affect how FDA performs their inspections of medical device manufacturers. The resulting shift would align the US market pathway more closely to other major international device markets.

Topics covered include:

  • How this effort will make compliance more efficient for manufacturers commercializing in multiple markets
  • Understanding changes to the Quality System Inspection Technique (QSIT) inspection model and how it may move closer to the Medical Device Single Audit Program (MDSAP) Audit Model utilized by the International Regulatory Consortium of Australia, Brazil, Canada, Japan, and US with even the European Union discussing utilization of MDSAP audits
  • A look at the transition time frame and impacts for the agency and medical device manufacturers