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.

See What I Do Let's Talk
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
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Clinical Consultant — DRSWN

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

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

2022 — 2023
Wearable phototherapy for newborn jaundice. Led product development, regulatory & IP strategy, team of 12.
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Senior Inspector — IGJ (Dutch Health & Youth Care Inspectorate)

2020 — 2022
MDR, compliance audits, market-introduction monitoring, post-market surveillance oversight, and clinic audits.
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PhD Researcher — Amsterdam UMC / University of Amsterdam

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

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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
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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
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
van Riel LAMJG*, Swaan A* et al. Image-guided in-vivo Needle-Based Confocal Laser Endomicroscopy in the Prostate: Safety and Feasibility Study in 2 Patients. Technology in Cancer Research & Treatment. (*Equally contributed)
2021
Swaan A. The analysis of prostate tissue by optical coherence tomography. PhD Thesis, Faculty of Medicine (AMC-UvA). ISBN 9789464023114
2020
Swaan A, Muller BG, Wilk LS et al. En-face optical coherence tomography for the detection of cancer in prostatectomy specimens: Quantitative analysis in 20 patients. J Biophotonics.
2019
Swaan A, Mannaerts CK, Muller BG et al. The First In Vivo Needle-Based Optical Coherence Tomography in Human Prostate: A Safety and Feasibility Study. Lasers in Surgery and Medicine.
2018
Swaan A, Muller BG, Wilk LS et al. One-to-one registration of en-face OCT attenuation coefficients with histology of a prostatectomy specimen. J Biophotonics.
2018
Swaan A, Mannaerts CK, Scheltema MJV et al. Confocal laser endomicroscopy and OCT for the diagnosis of prostate cancer: needle-based in-vivo feasibility study protocol (IDEAL phase 2A). J Med Internet Res.
2016
Muller BG, Swaan A, de Bruin DM et al. Customized Tool for Validation of OCT in Differentiation of Prostate Cancer. Technology in Cancer Research & Treatment.
2015
Wagstaff PG, Swaan A et al. In vivo, percutaneous, needle-based OCT of renal masses. Journal of Visualized Experiments.

Ready to move your device forward?

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

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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.

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abelswaan@proton.me
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www.drswn.com
📍
Netherlands
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linkedin.com/in/abelswaan
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BIG Registered