For MedTech Founders & Regulatory Affairs Directors
Certify in months, not years.
EU MDR certification in three to six months instead of three years. Build MDR applies the Subtract to Ship method to medical device regulation.
The Problem
Three-year audit cycles are not a law of nature.
Additive thinking in regulatory
Every new requirement gets added to the technical file. Nothing gets removed. The submission scope grows until the audit timeline stretches past three years.
The cost of delay
Every month a device sits in the certification queue is a month of zero revenue, continued burn, and competitive ground lost. Most of that time is spent on documentation that never gets read.
Over-scoped submissions
Teams add scope because removing scope feels risky. But auditors do not reward completeness. They reward clarity. A smaller, tighter technical file passes faster.
Co-author
Written with Tibor Zechmeister.
The Method, Applied to MDR
Subtract to Ship for medical devices.
- 01
Subtraction Audit for technical files
Inventory every element in the technical file. Identify what the auditor will actually review, what is redundant, and what is scope bloat that slows the process without improving the outcome.
- 02
Kill List for regulatory scope
A prioritized list of what to remove from the submission. Not guesswork — a structured decision framework built on twenty years of audit experience. Each removal is documented and defensible.
- 03
Defend the removal
The hardest part is not knowing what to cut. It is defending the cut in front of the auditor. The book covers exactly how to frame, document, and present a reduced scope so it passes on the first review.
The Book
Build MDR
EU MDR certification through subtraction. Written by Felix Lenhard and Tibor Zechmeister. Releasing September 15, 2026.
Frequently Asked Questions
Common questions about Build MDR.
- Is this for Class I, II, or III devices?
- The method applies to all risk classes. The regulatory scope reduction works regardless of classification, though the examples focus on Class IIa and IIb.
- Who is Tibor Zechmeister?
- Notified Body Lead Auditor, founder of four MedTech companies, and founder of Zechmeister Solutions. He brings twenty years of regulatory experience to the Subtract to Ship framework.
- We are already mid-audit. Is it too late?
- No. The Subtraction Audit can be applied to an existing technical file at any stage. Chapter four covers mid-process intervention.
- Does this replace a regulatory consultant?
- No. It gives your team (and your consultant) a structured method for deciding what to remove from the submission scope. Most delays come from over-scoping, not under-preparation.
- When does Build MDR release?
- Build MDR releases alongside the Subtract to Ship series on September 15, 2026.
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Early excerpts and regulatory insights before the September 2026 release.