Principal Consultant
Medical Device Project B.V., Netherlands
Robert van Boxtel is Principal Consultant and management team member at Medical Device Project B.V. in the Netherlands. For almost 15 years, he supports the medical device industry with QA and RA related consultancy, focusing on the EU and USA. Additionally, he provides training to the industry, Notified Bodies and Competent Authorities on EU MDR, ISO 13485, Risk Management, auditing etc. He is hired by the Dutch Standards Institute (Royal NEN), as SME for training on ISO 13485 and MDD/MDR. Furthermore, he participates in TC210 discussions on quality management systems, risk management, PMS and is member of the Dutch horizontal standards committee.
Robert is Vice Chair of the RAPS European Council and Board Member of the RAPS Netherlands Chapter. He is member of the RAPS EU Convergence program committee and the newly established October conference in the EU.
Before joining Medical Device Project B.V., he worked at KEMA Quality Notified Body (now Dekra Certification) and in the medical device industry in several roles in design and production, both in the EU and the USA. As a result he has almost 30 years of experience in the medical device industry.
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Preconference Workshop: Effective Risk Management at the Core of MDR and IVDR
Tuesday, October 22, 2024
9:00 AM - 5:00 PM CEST
Opening Plenary Session: Evolving Regulatory Frameworks: Access to Innovation and Patient Safety
Wednesday, October 23, 2024
8:30 AM - 10:00 AM CEST
Closing Plenary: The Holy Trinity of the MDR – Risk management, Clinical Evaluation and PMS
Thursday, October 24, 2024
3:15 PM - 4:15 PM CEST