Dr. Abel Swaan — Technical Physician · BIG registered

Where Clinical
Science Meets
Regulatory Reality

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.

12.5+
Years MedTech
Experience
PhD
University of
Amsterdam
Hands-on
Clinical &
Surgical Experience
3D print
MedTech
Founder
The expertise I bring

Built on 12 years
of real-world MedTech

Dr. Abel Swaan
BIG Registered Technical Physician Art. 36a
PhD Faculty of Medicine, University of Amsterdam
MSc Technical Medicine, University of Twente
MedTech Startup Award 2014 winner

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.

Clinical Consultant — DRSWN

2026 — Present
Clinical Evaluation for Regulatory Approval and C-Level MedTech Interim Leadership.
💼

Clinical Consultant — MD squared

2023 — 2025
Clinical evaluations, CER authorship & review, clinical development plan, strategy, CE & FDA guidance.
🚀

CTO — Bilihome

2022 — 2023
Wearable phototherapy for newborn jaundice. Led product development, regulatory & IP strategy, team of 12.
🔍

Senior Inspector — IGJ (Dutch Health & Youth Care Inspectorate)

2020 — 2022
MDR, compliance audits, market-introduction monitoring, post-market surveillance oversight, and clinic audits.
🔬

PhD Researcher — Amsterdam UMC / University of Amsterdam

2014 — 2020
Optical coherence tomography for prostate cancer diagnosis. In-vivo human & animal trials, catheter prototyping.
💡

Founder — SpineGuide

2013 — 2017
3D-printed patient-specific orthopedic drill guides. MedTech Startup Award 2014 winner.
Services

Two offerings.
One expert.

Leveraging extensive clinical research, regulatory inspection expertise, and C-level startup experience, I am ready to contribute wherever you need the most impact.

🔬

Clinical Evaluations for Regulatory Approval

Rigorous, literature-based clinical evaluation reports (CER), PMCF plans, and post-market surveillance documentation aligned with EU MDR and FDA requirements.

CER / SSCP PMCF Plans EU MDR FDA 510(k) PMS Reporting Clinical Investigation Design
👔

C-Level MedTech Interim Leadership

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.

Interim CMO / CTO Clinical Strategy Regulatory Affairs Product Development Team Leadership
Also by DRSWN

Fast app for a quick scout.

Fast FDA predicate chains on your phone.

510(k)
Explorer
510(k) Explorer
Search · Graph · Timeline

510(k) Explorer

Fast FDA 510(k) Predicate Chains

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.

Graph View — explore predicate relationships as an interactive network; drag nodes, pinch to zoom, tap for full clearance details.
Timeline View — see the full predicate lineage plotted on a proportional time axis, spanning decades of device history at a glance.
Device Details — K-number, applicant, indications for use, full predicate list, and one tap to the official FDA 510(k) summary PDF.
Always current — refresh directly from the FDA database to pull in the latest clearances as they are issued.
Download on the App Store
What Sets DRSWN Apart

Not just a consultant.
I'll provide advice from different perspectives.

How It Works

From first call to approved device

A clear, four-step engagement — with a transparent scope.

01

Discovery Call

I assess your device, regulatory status, timeline, and define the right scope of engagement.

02

Strategy & Plan

A tailored clinical and regulatory roadmap with clear milestones, deliverables, and responsibilities.

03

Execution

CER writing, technical file support, or embedded interim leadership — delivered on time, to standard.

04

Cleared & Beyond

Regulatory approval in hand, with continued PMS and PMCF support as your device evolves.

Scientific Background

Peer-reviewed research

10+ publications in biophotonics, optical coherence tomography, and cancer diagnostics — the scientific foundation behind every clinical evaluation I deliver.

2022
Image-guided In Vivo Needle-Based Confocal Laser Endomicroscopy in the Prostate: Safety and Feasibility Study in 2 Patients
van Riel LAMJG*, Swaan A* et al.  ·  *equal contribution
Technology in Cancer Research & Treatment, Vol 21, 2022  ·  DOI: 10.1177/15330338221093149  ·  PMID 35790459
2021
The Analysis of Prostate Tissue by Optical Coherence Tomography
Swaan A.
PhD Thesis, Faculty of Medicine, University of Amsterdam (AMC-UvA)  ·  ISBN 978-94-6402-311-4
2020
En-face Optical Coherence Tomography for the Detection of Cancer in Prostatectomy Specimens: Quantitative Analysis in 20 Patients
Swaan A, Muller BG, Wilk LS, Almasian M, Zwartkruis ECH, Rozendaal LR, de Bruin DM, Faber DJ, van Leeuwen TG, van Herk MB
Journal of Biophotonics, 13(6):e201960105, 2020  ·  DOI: 10.1002/jbio.201960105  ·  PMID 32049426
2019
The First In Vivo Needle-Based Optical Coherence Tomography in Human Prostate: A Safety and Feasibility Study
Swaan A, Mannaerts CK, Muller BG, van Kollenburg RAA, Lucas M, Savci-Heijink CD, van Leeuwen TG, de Reijke TM, de Bruin DM
Lasers in Surgery and Medicine, 51(5):390–398, 2019  ·  DOI: 10.1002/lsm.23093  ·  PMID 31090088
2019
One-to-one Registration of En-face Optical Coherence Tomography Attenuation Coefficients with Histology of a Prostatectomy Specimen
Swaan A, Muller BG, Wilk LS, Almasian M, van Kollenburg RAA, Zwartkruis E, Rozendaal LR, de Bruin DM, Faber DJ, van Leeuwen TG, van Herk MB
Journal of Biophotonics, 12(4):e201800274, 2019  ·  DOI: 10.1002/jbio.201800274  ·  PMID 30565879
2018
Confocal Laser Endomicroscopy and Optical Coherence Tomography for the Diagnosis of Prostate Cancer: A Needle-Based, In Vivo Feasibility Study Protocol (IDEAL Phase 2A)
Swaan A, Mannaerts CK, Scheltema MJV, Nieuwenhuijzen JA, Savci-Heijink CD, de la Rosette JJ, van Moorselaar RJA, van Leeuwen TG, de Reijke TM, de Bruin DM
JMIR Research Protocols, 7(5):e132, 2018  ·  DOI: 10.2196/resprot.9813  ·  PMID 29784633
2017
Customized Tool for the Validation of Optical Coherence Tomography in Differentiation of Prostate Cancer
Muller BG, Swaan A, de Bruin DM, van den Bos W, Schreurs AW, Faber DJ, Zwartkruis ECH, Rozendaal L, Vis AN, Nieuwenhuijzen JA, van Moorselaar RJA, van Leeuwen TG, de la Rosette JJMCH
Technology in Cancer Research & Treatment, 16:57–65, 2017  ·  DOI: 10.1177/1533034615626614  ·  PMID 26818025
2016
Percutaneous Needle-Based Optical Coherence Tomography for the Differentiation of Renal Masses: A Pilot Cohort
Wagstaff PGK, Swaan A, Ingels A, de Bruin DM, van Dijk MCRF, Vergunst H, van Leeuwen TG, de la Rosette JJMCH, de Reijke TM
Journal of Urology, 195(5):1578–1585, 2016  ·  DOI: 10.1016/j.juro.2015.12.072  ·  PMID 26719027
Common Questions

Quick answers

Short explainers on what I do, who I work with, and what makes my background unusual in MedTech consultancy.

A Technical Physician (Technisch Geneeskundige) is a Dutch clinical specialist trained at the University of Twente in both engineering and medicine — uniquely positioned to bridge the gap between clinical practice and medical device development. Registered under Article 36a of the Dutch BIG Act, Technical Physicians are authorised to perform clinical procedures independently. In the MedTech context this means Dr. Swaan can evaluate a device from a clinician's perspective, understand the engineering trade-offs, and translate both into the regulatory language required by EU MDR or FDA — a combination most consultants must assemble across a team.
Any medical device manufacturer seeking a CE mark under EU MDR (EU 2017/745) must produce a Clinical Evaluation Report demonstrating that their device is safe and achieves its intended clinical performance. The CER is a systematic review of clinical data — from literature, post-market surveillance, and clinical investigations — structured according to MEDDEV 2.7/1 rev.4 and MDR Annex XIV. It must be updated continuously throughout the device lifecycle. Dr. Swaan authors and reviews CERs, Clinical Development Plans (CDPs), Post-Market Clinical Follow-up (PMCF) plans, and Summary of Safety and Clinical Performance (SSCP) documents. He also supports FDA 510(k) and PMA submissions requiring clinical evidence packages.
DRSWN — Dr. Abel Swaan — is an independent clinical and regulatory consultant based in the Netherlands specialising in MDR clinical evaluation for medical device companies. Unlike large consultancy firms, DRSWN offers direct access to a senior expert who has written CERs, held a regulatory inspector role at the Dutch IGJ, and conducted clinical research on novel medical devices. This combination of authorship, inspection, and clinical research experience in a single consultant is rare. DRSWN works with startups preparing their first CE mark, established manufacturers transitioning legacy devices to MDR, and international companies entering the European market.
When a MedTech company loses a CTO, CMO, or regulatory director — or needs to scale rapidly without the runway to hire permanently — an interim C-Level leader fills the gap immediately. Dr. Swaan has served as CTO at Bilihome, leading a team of 12 through product development, regulatory strategy, and IP management for a wearable phototherapy device. As an interim leader he can own a technical roadmap, represent the company to investors and Notified Bodies, manage cross-functional development teams, and drive regulatory submissions in parallel. Engagements typically run from three months to over a year, at a commitment level agreed upfront.
Dr. Swaan's clinical research background centres on optical coherence tomography (OCT) for cancer diagnostics used in the prostate. His CTO role at Bilihome involved a wearable phototherapy device for neonatal jaundice (Class IIa). His regulatory inspection work at IGJ covered the full range of medical device classes. Through DRSWN he now advises on devices across Class I through Class III, with particular strength in urology, cardiology, and orthopedic devices requiring clinical evaluation for EU MDR or FDA approval.

Ready to move your device forward?

Let's talk about your regulatory pathway and how I can accelerate it.

Start the Conversation →
Contact

Let's work together

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.

🌐
www.drswn.com
📍
Netherlands
🏅
BIG Registered