Build MDR

Who Tibor is, and why this book exists

Build MDR came out of months of work between Felix and Tibor. Tibor brings the regulatory backbone — the file structures, the audit cycles, the specific Notified Body language, the harmonised standards (EN ISO 13485, EN ISO 14971, EN 62304, EN ISO 14155, EN ISO 10993-1) and the MDCG guidance that auditors actually cite. Felix brings the methodology: find the few things blocking the launch, remove them, defend the removal, ship.

The book is the joint output. Neither half works without the other.

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. The company was dead.

Not because the technology failed. Because the founders made eleven regulatory mistakes that compounded like interest on a loan they didn’t know they’d taken out. Tibor published the postmortem at the EMBEC 2024 conference. They built on the Iceberg Approach to regulatory knowledge, seeing the obvious requirements and assuming that was most of it. They burned months arguing whether the device was wellness or medical. They ran two expensive clinical investigations that proved what existing literature already showed. They picked the wrong conformity assessment procedure. They used 3D-printed materials certified for food safety but not biocompatibility, and had to redesign the whole product when the Notified Body flagged it. They waited four years to contact a Notified Body, only for that one to shut down in 2016 and force a restart.

EUR 2 million. Ten years. Eleven errors. Bankruptcy.

Read that list and the easy lesson is MDR is impossible for startups. That is the wrong lesson. Tremitas didn’t fail because MDR is broken. They failed because they didn’t understand the game they were playing. Every one of those eleven errors was preventable, not with millions in extra budget, not with a fifty-person regulatory team, but with knowledge, planning, and the right guidance at the right time.

That is what this book is.

A different number

Across his fifty-plus certification projects, Tibor’s clients consistently reach certification roughly seventy-five percent faster and at seventy percent lower cost than the industry average. Average post-submission certification timelines run thirteen to eighteen months; Tibor’s projects typically reach certification in three to six months. That is not a marginal improvement. That is a different economic model. The difference between a startup that runs out of money at month thirty and one that ships at month fourteen.

What Tibor does differently is in the regulation itself. Get the intended purpose right on day one. Engage the Notified Body early. Pick the right conformity assessment procedure from the start instead of reversing course after eighteen months. Set up the QMS before product development starts, not after. None of this is secret knowledge. It is all traceable to specific MDR articles. The problem is most founders don’t read those articles until something goes wrong.

What this book covers

• Documentation discipline. How to scope the Technical Documentation file under Annex II so the GSPR mapping stays clean and the audit trail stays short. With references to MDCG 2019-16 and MDCG 2022-14.
• CER scoping. What belongs in the Clinical Evaluation Report and what doesn’t. How to pre-empt the most common Article 61 NC patterns.
• Audit sequencing. How to set up the Notified Body review so the first cycle is a one-pass approval rather than a four-pass loop. What to send when, and why.
• Templates. The small set of regulatory artifacts that consistently move the needle (risk file structure, SSCP, PMS plan), and a frank list of the ones that look important but don’t.

Who it is for

MedTech founders, RA/QA leads, and quality managers in companies pursuing first-time MDR certification or recertification under the new framework. Article 15 PRRCs and QMRs who own the file. Notified Body auditors who want a cleaner submission in front of them.

One line from the auditor’s chair

If you can say it in half a page, don’t write twenty pages.

That sentence does most of the work in this book.

Background

The methodology side comes from the four-volume Subtract to Ship series and twenty years of innovation work. The regulatory side is Tibor’s, with fifteen years of audits, four founded companies, and 50+ certifications guided behind it. The cost of additive thinking in this domain is measured in years lost to the audit cycle, and the cost of disciplined removal is measured in launch windows kept.