Book 3 · Domain extension
MDR
The Subtract to Ship method, applied to EU MDR certification.
MDR is not your enemy. It is the rulebook for the game you chose to play. After certification it becomes your moat.
What you’ll take away
The MedTech founder's regulatory playbook.
01
How to compress a Technical Documentation file (Annex II) without losing GSPR coverage or traceability.
02
How to sequence the Notified Body submission so the audit cycle reads cleaner the first time, with fewer NCs.
03
Templates for the artifacts that move the needle (CER scoping, risk file pruning, SSCP), and a frank list of the ones that do not.
A different number
The gap is the whole book.
- 3–6 months
- Typical time to certification across Tibor's projects
- 13–18 months
- Industry average, post-submission
- 50+
- Certification projects behind the method
Figures from Tibor Zechmeister’s own project record across fifty-plus MDR certifications. Your timeline depends on device class, evidence position, and Notified Body capacity.
Why this book exists
The startup that did everything and still failed.
In 2011 an Austrian startup called Tremitas started building the Tremipen, a device that quantifies tremor. Solid idea. Motivated team. EUR 2 million in funding over the company’s lifetime.
Ten years later Tremitas filed for bankruptcy. The product had achieved MDD certification. It had never been commercially sold.
Not because the technology failed, but because the founders made eleven regulatory mistakes that compounded. Tibor published the postmortem at the EMBEC 2024 conference. Every one of those errors was preventable — not with a bigger budget or a fifty-person regulatory team, but with the right decision at the right time.
“If you can say it in half a page, don’t write twenty pages.”One line from the auditor’s chair. It does most of the work in this book.
In this book
Twenty chapters. Twenty expert insights.
Every chapter is followed by an Expert Insight: a working practitioner — founders, RA/QA leads, auditors and Notified Body reviewers — on what that stage actually costs them.
- 01Why MDR Doesn't Have to Kill Your Startup
- 02Product-Market-Fit for MedTech
- 03Business Model Analysis (Does the Math Work?)
- 04Who Buys Your Device? The Decision-Making Unit
- 05Understanding the Landscape (What Actually Applies to You)
- 06Classification (Getting Your Product Class Right)
- 07Team and Competences (Who Do You Actually Need?)
- 08Building a QMS from Scratch
- 09Technical Documentation (What Good Looks Like)
- 10Clinical Evidence Strategy (Where Startups Waste Money)
- 11Choosing a Notified Body (Timing, Fit, and Capacity)
- 12The Two-Phase Approach (Staying Agile in a Rigid World)
- 13Pre-Marketing (What You Can and Cannot Do Before CE)
- 14Post-Market Surveillance, Your Free Feedback Machine
- 15Health Insurance, Reimbursement & International Expansion
- 16Product Modifications (Plan for Change Before You Ship)
- 17The AI Advantage (What It Can and Cannot Do)
- 18Budget, Timeline & Resource Planning for Real Startups
- 19Saving Resources with the Right Measures
- 20The MDR Survival Checklist for Your Next 90 Days
Who it is for
People who own the file.
- MedTech founders pursuing first-time MDR certification or recertification under the new framework.
- RA/QA leads and quality managers who have to make the submission hold together.
- Article 15 PRRCs and QMRs who carry personal responsibility for the file.
- Notified Body auditors who would rather have a cleaner submission in front of them.
Written with
Tibor Zechmeister
Founder & EU MDR expert · Zechmeister Solutions →
Biomedical engineer with fifteen years in European MedTech. Accredited Notified Body Lead Auditor for both QMS and Technical Documentation. Founder of four medical device companies. Has advised more than fifty international MedTech operators and startups and chairs the Austrian Regulatory Affairs Professional Society LNG.
The full book page
Chapter detail, the story behind the book, and the rest of the catalogue live on the imprint site.
Launch Pads
The AI Launch Pads for this book are not live yet. Leave your email and we will tell you the day they are.