Subtract to Ship: MDR Playbook · Chapter 13 Checklist

Pre-Marketing Compliance Audit

From Chapter 13: Pre-Marketing (What You Can and Cannot Do Before CE)

Free PDF. Direct download, no email required.

What this checklist does

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.

Time to complete: 1 to 2 hours, done today rather than next week

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The playbook is hosted by Zechmeister Strategic Solutions, the MedTech regulatory consultancy of co-author Tibor Zechmeister.

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