12+ years at the intersection of MedTech innovation and clinical evidence — from the PhD lab to the Inspectorate, from deep-tech startups to CE-marked devices. I bring that full journey to your next regulatory challenge.
Dr. Abel Swaan is an independent MedTech consultant with over twelve years of hands-on experience spanning clinical research, regulatory inspection, and C-level product leadership. Trained as a Technical Physician at the University of Twente and holding a PhD from the University of Amsterdam's Faculty of Medicine, he combines rare depth across three domains that most consultants cover only one of: clinical science, regulatory strategy, and medical device development.
Under DRSWN he offers two distinct services: Clinical Evaluations for regulatory approval — producing Clinical Evaluation Reports (CERs), clinical development plans, and supporting EU MDR and FDA submissions for medical device companies across Europe and beyond — and C-Level MedTech interim leadership, stepping in as CTO, CMO, or interim director when companies need experienced hands at the helm during pivotal moments. His inspector background at the Dutch Health & Youth Care Inspectorate (IGJ) means he has sat on both sides of the regulatory table, giving clients a practical edge that purely academic or purely industry consultants cannot replicate.
Registered in the Dutch BIG-register as a Technical Physician under Article 36a — one of the Netherlands' most demanding clinical-technical credentials — Dr. Swaan's six years of doctoral research at Amsterdam UMC produced 10+ peer-reviewed publications in journals including Journal of Biophotonics, Lasers in Surgery and Medicine, and Technology in Cancer Research & Treatment. As Senior Inspector at the Dutch Health & Youth Care Inspectorate (IGJ) from 2020 to 2022, he led MDR compliance audits, market-introduction monitoring, and post-market surveillance oversight — giving him a perspective that is exceptionally rare among independent MedTech consultants.
Leveraging extensive clinical research, regulatory inspection expertise, and C-level startup experience, I am ready to contribute wherever you need the most impact.
Rigorous, literature-based clinical evaluation reports (CER), PMCF plans, and post-market surveillance documentation aligned with EU MDR and FDA requirements.
Experienced interim CMO / CTO / Chief Clinical Officer / Clinical & Regulatory embedded directly in your team. I've built a MedTech startup from concept to clinical trials — from prototypes to sales-ready, so interim leadership here means real hands-on ownership, not advisory distance. I can guide the team to real products and approval.
Fast FDA predicate chains on your phone.
Search across 99,000+ FDA clearances and instantly map how any device traces back through its predicate history. Built for regulatory professionals who need answers fast — not another browser tab full of PDFs.
Having audited as an IGJ Senior Inspector and conducted hard research as a PhD candidate, I know exactly what reviewers are looking for — and write CERs that anticipate those questions before they're asked.
Real clinical research credentials. My OCT and spectroscopy work at Amsterdam UMC wasn't desk research — it was in-vivo, first-in-human, multicenter trial execution.
Having built SpineGuide and led Bilihome as CTO, I understand the pressure of limited runway. I deliver regulatory quality at startup pace — without cutting corners that come back to bite.
BIG-registered Technical Physician in the Netherlands, with regulatory expertise across EU MDR and FDA — fluent in English and Dutch at academic level.
A clear, four-step engagement — with a transparent scope.
I assess your device, regulatory status, timeline, and define the right scope of engagement.
A tailored clinical and regulatory roadmap with clear milestones, deliverables, and responsibilities.
CER writing, technical file support, or embedded interim leadership — delivered on time, to standard.
Regulatory approval in hand, with continued PMS and PMCF support as your device evolves.
10+ publications in biophotonics, optical coherence tomography, and cancer diagnostics — the scientific foundation behind every clinical evaluation I deliver.
Short explainers on what I do, who I work with, and what makes my background unusual in MedTech consultancy.
Let's talk about your regulatory pathway and how I can accelerate it.
Start the Conversation →Whether you need a clinical evaluation authored by a technical physician, interim C-level leadership from someone who has designed devices, or targeted expert support on a tight deadline — reach out and let's find out if I'm the right fit.