Subtract to Ship: MDR Playbook · Chapter 16 Template
Product Modification Assessment & Change Control
From Chapter 16: Product Modifications (Plan for Change Before You Ship)
Free PDF. Direct download, no email required.
What this template does
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.
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.