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.

- >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

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.

Niels van Tienen has a background in sports and education with a master in Health Sciences. After an extensive training program at Medtronic both in the Netherlands and Minneapolis, US he joined forces with Factory-CRO in the Netherlands almost 10 years ago. As a project manager he is leading the clinical operations team. The team is responsible for setting-up and supervising clinical investigations in Europe and the US, including a variety of medical writing activities, for various medical devices companies.

Graduated in Physics (PhD), initial research area thin film technologies, then neurostimulation. As leader of the implant team developed innovative cochlear implants including conformity assessment of the CI-system, This device was the first medical device in AT to be CE-marked. Achieved market approvals in most markets. From 2004 to 2019 with the Austrian Authority (BASG, Federal Office for Safety in Healthcare) as Senior Expert, member of various MDEG Was and MDCG. Since 2020 active as consultant and trainer.