Subtract to Ship: MDR Playbook · Chapter 1 Worksheet
Is Your Product a Medical Device?
From Chapter 1: Why MDR Doesn't Have to Kill Your Startup
Free PDF. Direct download, no email required.
What this worksheet does
Determine whether your product falls under MDR scope before you commit resources to certification. Complete it honestly: ambiguity here costs years downstream.
Time to complete: 60 to 90 minutes, worked through with your founding team
Want all 20 worksheets in one download?
Download the Complete Pack (ZIP)The playbook is hosted by Zechmeister Strategic Solutions, the MedTech regulatory consultancy of co-author Tibor Zechmeister.