November 29 – 30, 2023
This two-day instructor-led course covers important requirements for medical device and IVD design controls, providing an understanding of design control principles and the design and development regulatory requirements relative to U.S. 21 CFR Part 820, ISO 13485:2016, and EU MDR, as well as practical examples. This course also provides guidance for all phases of medical device design and development projects, as well as a retrospective gap analysis of design history files to help develop new technical files under the EU MDR and IVDR.
Who Should Attend
This class is vital for any medical device research and development professional, regulatory scientist, and/or clinician involved in developing and manufacturing medical devices. This course provides critical knowledge for both regulatory affairs and quality assurance professionals.