Robert van Boxtel

Principal Consultant at Medical Device Project B.V

Advisor

Robert van Boxtel is Principal Consultant and management team member atMedical Device Project B.V. in the Netherlands. For almost 15 years, hesupports the medical device industry with QA and RA related consultancy, focusing on the EUand USA. Additionally, he provides training to the industry, Notified Bodies and CompetentAuthorities on EU MDR, ISO 13485, Risk Management, auditing etc. He is hired by the DutchStandards Institute (Royal NEN), as SME for training on ISO 13485 and MDD/MDR.Furthermore, he participates in TC210 discussions on quality management systems, riskmanagement, PMS and is member of the Dutch horizontal standards committee.Robert is Vice Chair of the RAPS European Council and Board Member of the RAPSNetherlands Chapter.Before joining Medical Device Project B.V., he worked at KEMA Quality Notified Body (nowDekra Certification) and in the medical device industry in several roles in design andproduction, both in the EU and the USA. As a result he has 30 years of experience in themedical device industry.His expertise’s are: EU medical device regulations (MDR/IVDR), ISO 13485:2016, Riskmanagement (including animal tissue); Clinical evaluation; PMS; QMS development /improvement; Troubleshooting; Product-, equipment- and process validation; Participating in/ leading development projects; Building Regulatory submission files (EU and USA); LeadAuditor.