Is 21 CFR Part 820 a Thing of the Past? Are You Ready for ISO 13485:2016?

On-Demand Webinar

As a Medical Device business, conforming to ISO-13485:2016 may no longer be an option.

Do you know if your quality management system meets applicable requirements for ISO 13485:2016?

The discussion will include:

  • FDA Plans to Modernize Medical Device Regulation and Replace Part 820
  • QS Harmonization under the EU Directives for Medical Devices (MDR)
  • The Impact on Medical Device Single Audit Program (MDSAP) participation
  • The Differences Between Part 820 and ISO 13485:2016
  • Business Advantages to Conforming to ISO 13485:2016
  • Live Q & A Session

About the Presenter:

Brian McCole 85x105 rightBrian McCole is the Director of the Enterprise Quality Management Services and Solutions at USDM Life Sciences. Brian is a highly experienced professional with a 20-year IT implementation track record. His experience includes 15 years of developing and supporting Quality Management System programs and 10 years of managing Enterprise Resource Planning system programs.




  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials