Ronald Boumans

Ronald
Boumans

Senior Consultant, Regulatory Affairs


Ronald Boumans brings with him 25+ years of experience in the medical device sector. He began in industry as a product designer; participated in research into quality of patients’ lives in relation to the use of medical devices; and worked 10+ years as an Inspector for the Dutch Healthcare Inspectorate, the Competent Authority for The Netherlands. As Senior Inspector, Ronald led a team responsible for the southern half of the country. He was further an incident analyst, a root cause analyst specialist, a trainer at the Dutch Inspection Academy, and a representative of The Netherlands in several working groups at the European Commission, such as the Compliance and Enforcement (COEN) group and the Medical Device Expert Group (MDEG) for borderline devices and classification. Ronald was also involved in the first impact assessments of the MDR/IVDR. Since joining Emergo by UL in 2013, Ronald has worked on 100+ projects, including Technical Files, Clinical Evaluation Reports, helping “orphaned” manufacturers maintain CE marking after their Notified Bodies left the market, and gap assessments between the MDD and MDR. On behalf of Emergo by UL, he sits on the Executive Board of the European Association of Authorized Representatives (EAAR). Ronald represents the EAAR in several groups at the European Commission, including the new EUDAMED Steering Committee and several of its working groups, such as post-market surveillance, vigilance, and data exchange. Ronald developed the two-day "MDR Skills Training" and is now developing training on UDI, PMS, and more.