Build MDR

EU MDR certification fails most often not because the documentation is wrong, but because there is too much of it. Files balloon to four-figure page counts. Notified Body reviews cycle three or four times. Companies miss launch windows by a year or more.

Build MDR is a working manual for medical-device companies pursuing EU MDR certification — written with Tibor Zechmeister, lead auditor and MedTech regulatory specialist with fifteen years inside the certification path. It applies the same removing discipline as the four-volume Subtract to Ship series, this time to the regulatory file.

What this book covers

• A documentation-removal pass: how to compress an MDR file by thirty to sixty percent without losing compliance.
• Audit sequencing: how to set up the Notified Body review as a one-pass approval, not a four-pass cycle.
• Templates for the regulatory artifacts that move the needle, and a frank list of the ones that do not.

Who it is for

MedTech founders, regulatory leads, and quality managers in companies pursuing first-time MDR certification or recertification under the new framework. Notified Body auditors who want a cleaner file in front of them.

Background

Build MDR extends the Subtract to Ship method into a domain where the cost of additive thinking is measured in years lost to the audit cycle. It is co-authored with Tibor Zechmeister of Zechmeister Solutions, whose fifteen years in the certification path provide the regulatory backbone.