Ronald Boumans has seen the medical devices field from almost every corner thinkable (R&D, distribution, research, certification, standard development, market surveillance, policy making, stakeholders representation and consulting), so he can approach most challenges from mulitple angles.

This helps the organizations he works with to adapt their approach to their challenges and keep full control over their processes. The ability of thinking out of the box is a precious added value in the field of regulatory compliance.

Graduated as an engineer in industrial design at the Technical University of Delft in 1986, Ronald started his career in R&D for medical devices (including package design). He then moved to importing and distributing devices in The Netherlands, followed by quality research and rearch into the relation between medical devices and quality of life.

This brought him to work for the Dutch competent authority as a senior inspector for medical technology. In 2013 he became a senior regulatory consultant at Emergo. In 2022 he started his own consulting company.

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Curriculum Vitae

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.

  • Senior Regulatory Consultant and PRRD for Emergo by UL
  • Senior Inspector for medical technology at the Dutch Healthcare Inspectorate
  • Senior Project Manager at TNO Quality of Life, managing research projects into the use of medical device and quality of life
  • Project coordinator at KBOH, coordinating projects into usability of medical devices
Including, but not limited to Products:
  • Cardiac catheters
  • Heart valves
  • Surgical equipment, including robotics
  • Contraceptives
  • Radio diagnostics
  • Disposable devices
  • Non-active implants, including vascular implants
  • Mobility aids
  • Pen injectors
  • Syringes
  • Wound healing
  • IVD self-tests
Disciplines:
  • European Union CE-Marking (AIMDD/MDD/IVDD and MDR/IVDR)
  • CER compilation
  • Incident analysis in healthcare organizations
  • Communication with competent authorities
  • Borderline and classification for medical devices in Europe
  • Notified Body searches
  • EUDAMED and UDI
  • Economic operator networks, both MDR and IVDR
  • Master of Science, Industrial Design, Technical University of Delft, Netherlands

Sampling of experience, not comprehensive

Clinical Evaluation Report compilation for a wide range of devices, including but not limited to:

  • X-ray equipment accessories
  • Cardiac catheters
  • Heart valves
  • Anti-fogging for endoscopes
  • Dental braces
  • Dental lasers
  • Orthopedic implants
  • Pen needle devices
  • Software for alarm systems

A wide range of borderline and classification questions, including but not limited to:

  • Devices containing a medicinal substance
  • Substances used diagnostically
  • Substances used therapeutically
  • Software
  • Bio-active markers

Urgent ad hoc projects, including but not limited to:

  • Serious incidents that unexpectedly raise in occurrence
  • “Orphaned” Manufacturers losing certification because their notified body became de-notified or reduced its scope
  • MDR ‘Article 59 procedures’, where a manufacturer seeks derogation from the CE-marking requirement

EU MDR transition gap analysis and gap closure

  • Native level Dutch and English fluency
  • Executive Board Member of the European Association of Authorized Representatives (EAAR) to the European Commission
  • Executive Board Member of the UK Responsible Person Association (UKRPA)
  • Executive Board Member of TEAM-PRRC
    • TEAM-PRRC delegate for Eudamed
    • TEAM-PRRC delegate for market surveillance
  • Member of the former EUDAMED Steering Committee, now MDCG Eudamed Working Group
  • Member of the EUDAMED Working Groups: post-market surveillance, vigilance and data exchange
  • Author of numerous White Papers on behalf of Emergo, including:
    • Understanding Europe’s New Medical Device Regulation – MDR 2017/745
    • Post-Market Clinical Follow-up (PMCF) Studies
    • European MDR 2017/745 Transition Timeline and Strategies
  • Developer of several RAMS modules for classification, especially involved in creating the basic structure and modules for MDR and IVDR.
  • Developed a two days’ MDR training and provided that globally.

 

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