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:
Vice President of Quality Initiatives Brian is a highly experienced professional with a 25-year track record of assisting quality-regulated companies define, develop, and achieve their compliance goals. His experience includes 15 years of developing and supporting Quality Management System programs and 10 years of managing Enterprise Resource Planning system programs.