Subtract to Ship: MDR
The MedTech Founder's Regulatory Playbook
All 20 worksheets from the book, exactly as printed. Free PDFs, direct downloads, no email required.
Or pick a single worksheet below.
Most medical devices don't fail in the lab. They fail in regulation.
The money runs out, the timeline quietly doubles, and a product that works perfectly sits on a shelf without CE marking. The pattern is always the same. And it is entirely preventable.
The founders who survive MDR don't outspend the regulation. They subtract. They cut the documentation they don't need, the consultants who slow them down, and the features that complicate classification without improving patient outcomes. They get the business model right before the first euro goes to regulatory work. That is the methodology behind this book.
Twenty chapters. Twenty playbook templates. The complete path from "Is this even a medical device?" to post-market surveillance, built on 50+ real certifications from both sides of the audit table.
You will walk away knowing whether any regulatory consultant you hire is competent. Before you write the first check.
Innovation Strategist and Product Builder. 100+ startups coached to market, 12 products shipped to 50+ countries with zero returns.
felixlenhard.comNotified Body Lead Auditor with 50+ MDR certifications, #2 MLVX100 Top Voice and Austrian State Prize Winner.
About TiborThe Device Decision
Before you regulate: is this a medical device, and does the business work?
Is Your Product a Medical Device?
Determine whether your product falls under MDR scope before you commit resources to certification. Complete it honestly: ambiguity here costs years downstream.
MedTech Product-Market Fit
Test whether real customers will pay for your device before you spend a single euro on regulatory work. Every field asks for answers grounded in real conversations, not assumptions.
The MedTech Napkin Test
The one-page business model test for MedTech startups, filled with real numbers from your Chapter 2 research. If the math does not fit on a napkin, you are overcomplicating it.
Decision-Making Unit (DMU) Diagnostic
Map every person involved in buying your device before you spend a euro on sales. Complete one DMU map per target customer type, filled from real conversations, not assumptions.
Landscape & Classification
The two decisions that set your entire regulatory path.
Intended Purpose & Regulatory Landscape Map
Draft the intended purpose statement that drives your classification, conformity assessment procedure, clinical evidence strategy, budget, and timeline. Two weeks of careful work here saves two years of regulatory rework.
Device Classification & Conformity Assessment Procedure
Walk through every classification rule in MDR Annex VIII systematically, with your intended purpose from Chapter 5 in hand. Do not skip rules that seem irrelevant: the strictest applicable rule wins.
Build the System
Team, quality management, and documentation that auditors can navigate.
Team Competence Gap Analysis
Map your team against MDR-required roles and assess actual competence, not CVs or job titles. If you cannot verify competence through specific questions and evidence, mark the gap.
QMS Setup from Scratch
Set up your quality management system from day one with a six-month build timeline. Start with the five core elements, then expand: a lean QMS that describes your real company beats a 500-page template with your name pasted on it.
Technical Documentation Architecture & Traceability Matrix
Build the skeleton first, then fill it. This template gives you the Annex II folder structure, the document ID system, and the traceability matrix format your auditor expects.
Evidence & Certification
Clinical strategy, the right Notified Body, and staying agile on the way.
Clinical Evidence Strategy Decision Tree
Walk through this decision tree before committing budget to clinical evidence. The difference between the cheapest pathway and the most expensive is a single strategic decision, so exhaust every alternative before defaulting to clinical investigations.
Notified Body Selection Framework
Treat Notified Body selection as a strategic decision, not an administrative checkbox. This five-variable framework separates the right partner from an 18-month detour.
Two-Phase Approach: Phase Assessment & Transition
Determine whether you are in Phase 1 (research: does this work?) or Phase 2 (medical device development: can we certify this?) and plan the transition. Starting Phase 2 too early wastes years on premature documentation.
To Market and Beyond
What you may say before CE, and what you must run after launch.
Pre-Marketing Compliance Audit
Audit every piece of customer-facing content your company has produced. Your Notified Body will look up your company during the audit, and any claim that exceeds your technical documentation is a nonconformity finding.
Post-Market Surveillance System Setup
Design your post-market surveillance system during development, not after launch. This template covers the five components of a lean PMS setup, the one regulatory obligation that doubles as free market research.
Reimbursement & International Expansion Planner
CE marking does not equal reimbursement, and it does not equal global market access. Separate the three tracks and build a realistic expansion sequence before telling investors about your international plans.
Product Modification Assessment & Change Control
Every product change is a regulatory event. Assess whether a modification is significant (requiring Notified Body involvement) or non-significant (internal change control), and plan for change at the development stage.
Ship Lean
AI, budget, partners, and the 90-day plan that pulls it all together.
AI Usage Safety Protocol for Regulatory Work
AI saves serious time on structured regulatory tasks, but it hallucinates in ways that look perfectly credible. This protocol makes sure AI output is verified before it enters your regulatory documentation: AI flags, the expert adjudicates.
MDR Budget, Timeline & Resource Planner
Plan with real numbers from real conversations with regulatory consultants, Notified Bodies, and test labs. Apply the Double-It Rule to every estimate; this may become the most referenced page in your regulatory planning.
Regulatory Partner Evaluation Scorecard
Score potential regulatory partners against five criteria. All five must pass: a partner with perfect qualifications who does not understand startup constraints will give you advice you cannot afford to follow.
The MDR Survival Checklist: Your Next 90 Days
The master execution checklist. It compresses the book's 52-week roadmap into your immediate next 90 days, the foundation phase that determines everything, with each item traced to a specific chapter.
The playbook is hosted by Zechmeister Strategic Solutions, the MedTech regulatory consultancy of co-author Tibor Zechmeister.