Strategic Solutions for MedTech zechmeister-solutions.com

Subtract to Ship · Launching September 2026

Subtract to Ship: MDR

The MedTech Founder's Regulatory Playbook

The regulation does not kill MedTech startups. The approach does. 20 chapters and 20 ready-to-use templates covering the complete EU MDR path, written from both sides of the audit table.

Felix Lenhard × Tibor Zechmeister

Subtract to Ship: MDR book cover

Why this book exists

The startup that did everything and still failed

In 2011, an Austrian startup began building a tremor-quantification device. Solid idea. Motivated team. EUR 2 million in funding.

Ten years later the company was bankrupt. Its device certified, but never commercially sold. Eleven regulatory mistakes, compounding like interest on a loan the founders never knew they had taken out. Every single one preventable.

One of those founders co-wrote this book, so yours does not become the next case study. Tibor published the full postmortem in a peer-reviewed paper. This book is the playbook he wishes the team had owned in year one.

The method

The core method is subtraction

Narrower intended purpose. Fewer features at the first CE mark. Lean but defensible evidence. MDR is a system with rules: learn the rules, subtract everything the rules and your customers do not need, then ship. After certification, the regulation becomes your moat.

Find

Identify the few regulatory decisions that actually block your launch: qualification, classification, evidence strategy.

Cut

Remove premature documentation, oversized scope, and consultant work that does not move the certificate.

Ship

Sequence the Notified Body submission so the audit cycle reads clean the first time, then reach the market.

Inside the 20 chapters

Read a chapter. Open the template. Keep working.

  • 01The full path. From "is this even a medical device?" through classification, QMS, technical documentation, clinical evidence, Notified Body selection, and post-market surveillance.
  • 0220 ready-to-use templates, one per chapter. A rolling start, not a reading assignment: you keep working the moment you finish reading.
  • 03The Two-Phase Approach. Separate R&D from regulatory development and stop paying for premature documentation.
  • 04The Double-It Rule. Honest cost ranges for Class I through Class III: total costs, not consultant fees.
  • 05The 600-to-1 Notified Body problem. A five-variable framework for choosing yours.
  • 06Real case studies with real numbers. The EUR 1.8 million product that never met a user, the classification argument that saved a year, the template QMS that failed its audit.
  • 07The operating system. A 52-week action plan, the complete MDR decision tree, the 20 questions every founder asks (and gets wrong), plus insights from 20 regulatory practitioners across Europe.
Preview of the 20 playbook templates included in the book
20
Chapters, one template each
52
Week action plan inside
11
Preventable mistakes, dissected in the case study
481
Pages, verified by a Lead Auditor

Written from both sides of the table

One knows founders. One knows audits.

The Builder

Felix Lenhard

  • Creator of the Subtract to Ship methodology
  • 12 physical products shipped to 50+ countries, zero returns
  • 15+ years in innovation strategy, 100+ startups coached to market
  • Client teams include Magna, voestalpine, Porsche, RHI Magnesita, and Wirtschaftsagentur Burgenland
Felix Lenhard Felix runs Vulpine GmbH and builds and ships products from Austria to the world. felixlenhard.com

The Auditor

Tibor Zechmeister

  • Accredited Notified Body Lead Auditor for QMS and Technical Documentation
  • 50+ companies guided through MDR certification
  • Founder of four MedTech companies, Austrian State Prize winner
  • Chairs the Austrian Regulatory Affairs Professional Society, #2 of 100 in the MLVX100 2026
Tibor Zechmeister Tibor runs Strategic Solutions for MedTech in Graz, Austria.

You get both.

Is this book for you?

Written for

  • Founders, CTOs, and regulatory leads at early-stage MedTech companies
  • Teams planning their first CE mark under EU MDR
  • Investors, advisors, and incubators who back MedTech startups
  • Anyone who wants to know if their regulatory consultant is competent, before writing the first check

Not for

  • Readers who want a legal commentary on the regulation
  • Anyone looking for a promise that certification takes six months. This book does not tell those lies.

Pre-launch

Be there when it ships

The book launches September 2026 on Amazon. The eBook opens at a reduced launch-week price before moving to its regular professional price. Join the list and we will send you the launch date and that price. That is the whole deal.