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About

The person you
would actually
be working with.

No account manager, no junior doing the file after a senior sold it. You get me, and where a project needs more hands I bring specialists I have worked with for years and tell you exactly who is doing what.

Portrait of Bjorn Delbeecke
Bjorn Delbeecke — Ghent, Belgium

I have been in this field long enough that the experience is best measured in dog years. It started in Brussels, lobbying on the MDR while it was still being argued over — for a trade federation, and then for a manufacturer at MedTech Europe. Next came the receiving end: leading that same regulation into a multinational's portfolio. Then the operating end, building two start-ups from an empty room to a certified quality system and a product on the market.

Since 2023 I have done that work for other people's companies. About twenty at any time, most in Belgium, the rest across France, the Netherlands, the UK and Taiwan. My training is in law and business rather than engineering, which is why the advice tends to arrive as a decision you can take rather than a rule you must obey.

What clients seem to value is the unglamorous part. Reading the guidance rather than the summary of it. Writing documents that hold up. Saying when the ambitious route is not worth it, and when it is.

  • PracticeMarket entry strategy, product development, company creation and audits
  • RolesPRRC and EU authorised representative for client companies
  • DomainsImaging, ionizing radiation, software and AI, disinfection and reprocessing, diagnostics, remote monitoring — and whatever the next product turns out to be
  • CertifiedISO 13485 lead auditor (BSI) · ISO 27001 lead auditor · ISO 20916 clinical performance studies
  • EducationMBA (Vlerick) and a master's in international and European law, alongside degrees in economics and political science

Career

Where the experience comes from.

  • 2023 →
    Founder and ownerMedea Consul

    Market entry strategy, product development, company creation and audits for start-ups and scale-ups. PRRC and authorised representative services. Around twenty companies at any time.

  • 2024 →
    Chief Operating OfficerZaparay

    UV-C high-level disinfection equipment. Responsible for strategy, quality, regulatory, legal and supply chain, and for a small team across R&D, clinical and production. Involved in fundraising and board preparation.

  • 2020 – 2024
    Head of Quality, Regulatory, Legal and OperationsXEOS Medical

    An intraoperative PET/CT scanner, built from nothing to CE mark and FDA 510(k), then to the UK, Switzerland and beyond. Set up manufacturing, installation and servicing across six contract manufacturers and around sixty suppliers.

  • 2018 – 2020
    MDR Programme Manager and QARA ManagerAgfa

    Led a multinational from the Medical Device Directive to MDR 2017/745 across radiology and software. Portfolio analysis that cut regulatory cost, manufacturing requirements rolled out from Brazil to China, and a clinical department built from scratch.

  • 2016 – 2017
    LobbyistCOCIR · MedTech Europe for Agfa · Siemens · EUROPEN

    Argued the MDR while it was still being written, from a trade federation and then on behalf of a manufacturer. Coordinated four European task forces and two global working groups; sat in Commission expert groups and on IEC/TC 62 and ISO/TC 215.

University

Teaching keeps the advice current.

A consultancy can coast on what it learned five years ago. A lecture hall does not let you. Since 2024 I teach medical device legislation at Ghent University and research how the law is actually implemented across member states — which is where most of the surprises in this field come from.

  • TeachingIntroduction to Medical Device Legislation, MSc Biomedical Engineering, Ghent University
  • ResearchNational implementation of EU medical device law across member states
  • ConveningMDR Day, QMS Day, the SME MedTech conference and the MedTech Winter School
  • AdvisoryIndustrial Research Fund, Ghent University — assessing life sciences spin-off potential
  • EcosystemFounding member of MeDTeG, Ghent University's medtech network
  • ReviewPeer reviewer, Journal of Clinical Monitoring and Computing

Recent publication: Delbeecke, B., & Verdonck, P. (2024). Legal duties of the anesthetists for reprocessing of single-use devices in the EU. Best Practice & Research Clinical Anaesthesiology, 38(4).

Next

Two ways to keep going.

If you have a device and a deadline, book a call. If you would rather see how I think before spending money on it, the reading list is a fair sample.

Book an intake call → Suggested readings