Robert van BoxtelPrincipal Consultant at Medical Device Project B.V., The Netherlands
Robert van Boxtel is Principal Consultant and management team member at Medical Device Project B.V. in the Netherlands. For more than 10 years, he supports the medical device industry with QA and RA related consultancy. 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.
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 over 25 years of experience in the medical device industry.