Clinical Evaluations for Class IIa/IIb/III Medical Devices — Audit-Ready for Your Notified Body.
I help small and medium-sized manufacturers with MDR-compliant documentation — focused on practicality and audit readiness.
Book a Free ConsultationWhat I do for you
Specialised MDR consulting for manufacturers of Class IIa, IIb and III medical devices.
Clinical Evaluation & PMS
Clinical evaluations per MDR Article 61 — from literature search to the complete CER. Including PMS plans and evaluation reports. Study designs if needed.
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MDR Consulting Class IIa/IIb/III
Post-market surveillance, technical documentation, risk management, and audit preparation. Documents that hold up under review by your Notified Body.
Learn moreWhy manufacturers work with me
Specialised, not general
Focus on clinical evaluations and PMS for Class IIa, IIb and III. Deep expertise where it counts.
Experience with Notified Bodies
I know the typical queries and most common deficiencies. My documentation anticipates them.
Direct and personal
You work directly with me — short lines of communication, clear updates, no agency structure.
Actionable, not theoretical
Finished, audit-ready documents — not concept papers. Ready to submit to your Notified Body.
Does this sound familiar?
Your Notified Body has raised questions about your clinical evaluation. The deadline is approaching. Internally, you lack the capacity to address the issue properly.
Or: you’re preparing for initial certification and aren’t sure whether your documentation will withstand the scrutiny of your Notified Body under the MDR.
These are exactly the situations where I support manufacturers.
Who I work with
I support small and medium-sized medical device manufacturers in Classes IIa, IIb and III:
- Preparing for initial certification under the MDR
- Going through re-certification with updated requirements
- Responding to specific Notified Body queries on the clinical evaluation
- Strategic design of the PMCF plan, including study designs
- Building or updating the PMS system and technical documentation
- Audit preparation when the clinical evaluation is in focus
How we work together
Initial consultation
20 minutes, free. You describe your situation — I'll tell you honestly whether and how I can help.
Proposal
Clear proposal with defined scope, timeline, and fixed price.
Execution
Independent work, regular coordination. You receive audit-ready documents.
Frequently Asked Questions
Typically I need your existing technical documentation, the intended purpose of the device, and — if available — previous clinical evaluations or PMS reports. In the free initial consultation we clarify together what is specifically needed. Getting started is straightforward.
That depends on the complexity of the device and the available data. A typical clinical evaluation takes between 2 and 4 months. In the proposal you receive a concrete timeline — and I stick to it.
My experience covers Class IIa, IIb and III medical devices in ophthalmology, dermatology, orthopaedics, gynaecology, and cardiology — including IOLs, viscoelastic gels, lasers, implants, and electromedical devices. If your device falls into a different area, we clarify in the initial consultation whether my expertise is a good fit.
Every project receives a clear proposal with defined scope and fixed price — no open-ended hourly billing, no surprises. Costs depend on scope: a PMS plan is different from a complete clinical evaluation. In the initial consultation we discuss your situation, after which you receive a concrete proposal.
Then I support you with those. My documentation is structured to anticipate typical queries. Should your Notified Body still have questions, I address them together with you — that's part of my commitment to audit-ready results.
Facing a regulatory challenge? Let's talk.
In 20 minutes we'll clarify where you stand and how I can support you. Free and without obligation.
Book a Free Consultation