sitem-insel AG

Dr. Jürgen Berndt

Independent Consultant



Modules

Medical Device Regulatory Affairs and Quality Assurance:


Biography

Jürgen Berndt has more than 30 years of experience in regulated industries including 18 years with 3M, where he was the European lead of the Quality and Regulatory functions for 8 years. In 2009 he joined Synthes and subsequently DePuySynthes, Johnson & Johnson`s orthopedic business, working in various Regulatory Affairs leadership roles.

Juergen closely followed the European regulatory landscape transformation from individual national registration schemes to a uniform EU device legislation (MDD) and contributed to further improvement of a harmonized EU medical device legislation working for more than 20 years in various trade associations in Germany, Switzerland and at European level. He also worked with a number of Notified Bodies and Health Authorities successfully creating trustful and constructive relationships.

Since 2011 he has contributed to the development of the new EU medical device legislation (MDR) through internal company working groups, supporting trade association working groups and in depth discussions with various Notified Bodies.

His experience covers all activities related to regulatory and quality processes to support product development, manufacturing and third company suppliers, classification and conformity routes, EU and international registrations, post market surveillance activities, due diligence support of acquisitions, leveraging external resources and management consultants as well as working with trade associations developing position papers and feedback to new regulations and guidelines.

Jürgen received a Diploma of Biology and a PhD of Natural Sciences from the University of Cologne, Germany.

He retired from Johnson & Johnson in May 2020 and now shares his knowledge and experience as a lecturer of the Medical Device Regulatory Affairs and Quality Assurance study program at the University of Bern.