- >20 years experience as pharmaceutical and medical device regulator in the Dutch government, successively in Medicines Evaluation Board, Ministry of Health and CCMO (governmental organization for clinical investigations) - Lead for European Regulation in Philips (global medtech company), co-leading Philips’ EU MDR/IVDR Implementation Program - Currently Regulatory Strategy Principal in Notified Body TÜV SÜD - Chair of NB-MED (formal EU Commission’s working group of Notified Bodies and Vice-President of Team-NB (association of EU Notified Bodies) - Long track record in global professional organizations DIA and RAPS - Regular speaker and faculty member in educational conferences on regulatory topics - Holding PharmD of Leiden Univer

Joris Bannenberg is a medical doctor with a PhD in surgical techniques. He has over 24 years of experience with medical devices in experimental and clinical trials, surgical procedures and implantation techniques and clinical research for medical devices. He has trained over 2500 surgeons in many minimal invasive surgery courses. As medical director/consultant/regulatory affairs he was responsible for many medical device studies for various medical device companies, from small ones to multi-nationals, in several medical specialty fields.

Gert is an expert in European regulations based on 15 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, head of notified body. He led the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level.

Jos Kraus, Pharm. D., is a former Senior Inspector of the Medical Technology of the Inspectorate of Health Care in the Netherlands. He is as a hospital pharmacist specialized in (validation of aseptic) production. Mr. Kraus worked for a Notified Body before joining the Inspectorate of Health Care. Onwards he was actively involved in the development of the Directives and MEDDEVS. As a member of the EU Medical Device Expert Group, he participated in the major European working and experts groups, like Classification, IVD, NBOG, MSOG, Borderlines and Classification and MRA’s. He works at the Academic Medical Centre of the University of Amsterdam, as a consultant of the board.