Ronald Boumans brings with him 30+ years of experience in the medical device sector. He began in industry as a product designer of medical devices; started a company importing medical devices into The Netherlands from Asia; participated in research into quality of patients’ lives in relation to the use of medical devices; worked 10+ years as an Inspector for the Dutch Healthcare Inspectorate, the Competent Authority for The Netherlands; and worked for nine years as a senior regulatory consultant for Emergo Europe Consulting B.V..
As Senior Inspector, Ronald led a team responsible for manufacturers, importers and distributors of medical devices and IVD’s in 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 represented 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.
For Emergo by UL (2013-2019) Ronald has worked on 200+ 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. He also developed several MDR related trainings, which he provides globally. In uncertain situations, like Brexit or the Swiss relations to the EU, he used his extensive network to help Emergo and its clients navigate unclear waters.
On behalf of Emergo by UL, he sat on the Executive Board of the European Association of Authorized Representatives (EAAR). Ronald represented 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, data exchange, as well as the MDCG working group on UDI. He also took part in stakeholders meetings with the European Commission. He also was board member on behalf of Emergo UK in the UK Responsible Person Association (UKRPA) where he frequently took part in meetings with the MHRA.
He has developed a deep understanding of the role of the Person Responsible for Regulatory Compliance (PRRC). He is also board member of TEAM-PRRC, where he helps shaping this new profession. He is involved in further developing the industry level of understanding of this role via his network and by developing guidance and training.