Felix Lenhard and Tibor Zechmeister · September 2026
Subtract to Ship: MDR
The MedTech Founder's Regulatory Playbook
For founders bringing a medical device to market under the EU MDR, written with a Notified Body Lead Auditor. Twenty chapters, from “is this even a medical device?” to post-market surveillance, with a ready-to-use template for each chapter.
“I haven’t seen another MDR book written this directly for startup founders.”
“The “do less at the first CE mark” idea really stuck with me.”
“Practical, direct, and refreshingly free of legal jargon.”