Robert van Boxtel

Principal Consultant at Medical Device Project B.V., The Netherlands

Speaker, Advisor

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.
As volunteer, Robert is Vice Chair of the RAPS European Council and per January 1, 2025 the Chair. Additionally, he is Board Member of the RAPS Netherlands Chapter. He contributes to two RAPS conferences and the Medtech Summit in Europe.
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 30 years of experience in the medical device industry.