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Senior MedTech Advisory

Getting a medical device to the market is hard.
Getting expert advice shouldn't be.

Qualinq is a senior medtech advisory boutique. We help startups, scale-ups and SMEs navigate clinical strategy, regulatory requirements, and supplier selection — with hands-on experience that larger firms can't offer and solo specialists can't cover.

◆  Senior-only: work with the founders
◆  Pragmatic, business based approach
◆  Europe / MDR focus
◆  Class I & IIa low-risk devices

foto HOW WE HELP
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How we can help you

Does this sound familiar?

DEVELOPING OR MANUFACTURING DEVICES

◆  The good advisors are either too expensive or too narrow.

◆  You're moving from 510(k) or MDD to MDR and want a lean route.

◆  Your regulatory path is unclear and your clinical evidence may not hold up.

◆  You're raising money and your regulatory story has to be solid.

SELLING REUSABLE INSTRUMENTS IN EUROPE

◆  You need to find or qualify suppliers, but the landscape is opaque.

◆  Your reusable instruments are still on an MDD self-declaration, and nobody can tell you what it takes to survive the 2028 MDR deadline.

◆  You put your own brand on instruments made in Asia — which makes you the manufacturer under the MDR, whether you planned to be or not.

Senior advisory. At a level that's rarely available to startups.

Qualinq was founded by Ralf Heijkants and Huibert Tjabbes, two professionals with deep roots in the European medtech industry. Huibert has co-founded multiple medical device companies and brings clinical and entrepreneurial experience. Ralf has spent over a decade as an independent consultant in regulatory affairs, quality management, and medical device development.

We built Qualinq because we kept seeing the same gap: startups that needed senior, integrated advice but couldn't easily access it.

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A way through the complicated European landscape

We don't offer a fixed package. We start with a conversation about your needs — then work as a direct, senior partnership across the disciplines that matter.

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Medtech Advisory

Clinical strategy, regulatory pathway, QMS, supplier selection, investor readiness — from people who have built and launched medical devices themselves. One engagement, no gaps between disciplines.

Supplier intelligence

Finding and qualifying the right ISO 13485 certified supplier is harder than it should be. We help you navigate it — using our database of [10,000]+ certified European suppliers and our knowledge of the market.

Clinical validation and market (re) authorization

Every device needs a clinical evaluation demonstrating conformity with the relevant General Safety and Performance Requirements (GSPRs, Annex I). This is often seen a important barrier for obtaining  market authorization. We offer pragmatic advise based hands-on experience. 

Reusable surgical instruments: class Ir

By the end of 2028 every reusable instrument in Europe needs a notified body. In the European register only a few dozen suppliers have one, and many never will. That shelf space comes free. We map where you stand and help you solve the EU manufacturer problem.

Pooled auditing: share the cost of supplier audits.

A model where multiple medtech companies share the cost of auditing the same supplier — instead of everyone paying separately for the same check. Early interest welcome.

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An unique supplier databaseS

◆10,000+

◆ISO 13485 certified suppliers across Europe.

A database of certified suppliers and contract manufacturers — covering certification scope, product and technology focus, company size, location and more. Cross-referenced with EUDAMED, so you can see not just who claims certification, but who actually holds it. One of the tools we use to help you find and qualify the right partners.

◆Company name, location and contact details

◆ISO 13485 certification status and scope

◆Product and technology categories

◆Contract vs. own-brand manufacturer classification

◆Continuously updated and improved

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About us

We've been where you are.

Qualinq was founded by Ralf Heijkants and Huibert Tjabbes — two professionals with deep roots in the European medtech industry. We built Qualinq because we kept seeing the same gap: startups that needed senior, integrated advice but couldn't easily access it.

Ralf Heijkants

Ralf Heijkants

Co-founder — Regulatory & QMS

An independent medical device consultant with over a decade of experience in regulatory affairs, quality assurance and medical device development. His background at organisations including Dekra, TNO and UMC Utrecht gives him a grounded, practical perspective on getting a device to market in Europe.

LinkedIn →

Huibert Tjabbes

Huibert Tjabbes

Co-founder — Clinical & entrepreneurial

An experienced medtech entrepreneur with a background as an MD. He has co-founded several medical device companies, including Novioscan and Envision Medical, guided early-stage projects and academic spin-outs to market, organized international clinical trials, and is an active Horizon Europe Expert Evaluator.

LinkedIn →

 

Why Qualinq?

The European medtech advisory market has no shortage of firms. But senior, integrated, pragmatic advisory that combines clinical, regulatory and supply-chain expertise is not easy to find — especially for startups and smaller companies. That's the gap we're filling. The proprietary supplier database we've built is one concrete expression of that: knowledge that took years to assemble, now made useful.

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Contact

Triggered? Interested in talking to us?

Tell us where your project stands. We'll have an honest conversation about whether — and how — we can help.

Ralf Heijkants
heijkants@qualinq.com  ·  +31 6 38229175

Huibert Tjabbes
tjabbes@qualinq.com  ·  +31 6 29056631

General: info@qualinq.com

Foto Utrecht voor ABOUT US