Michael Chellson has over 30 years of experience in the field of medical devices as a laboratory scientist, an operational quality assurance leader and a global quality and regulatory leader. He has focused on assisting organizations with EU MDR compliance since publication of the first EC draft.
Through practical executions of operations, regulatory affairs and quality systems, he has developed and implemented risk-based solutions to integrate business functions and improve operational and quality performance. He’s led technically-oriented projects focusing on design controls, verification and validation, process improvement, regulatory market clearance, risk management and implementation of corrective actions.
In earlier roles, he served as Global Director RA with Sunrise Medical and VP RA/QA with ConMed Corporation. He also served on several U.S. FDA working groups, both as an industry partner in development of published FDA product safety guidance (SHBWG) and as a member of initial U.S. FDA “case for quality” initiatives.
Mr. Chellson began his career working with QA, microbiological and sterility testing for processed food. He then held increasingly senior positions in QA/RA leadership and consulting at small and large medical device manufacturers.