Medical Device Adverse Event Reporting Template – QMSR Compatible

QMSR Compatible Adverse Event Reporting Procedure Template

When a serious injury or device malfunction occurs, your team needs to act fast — and your documentation needs to be airtight. This Adverse Event Reporting template gives medical device manufacturers a structured, audit-ready procedure compatible with QMSR (21 CFR Part 820) and FDA Medical Device Reporting (MDR) requirements under 21 CFR Part 803.

What's Included

• Complete Adverse Event Reporting procedure compatible with QMSR and 21 CFR Part 803
• MDR decision tree for determining reportability
• Complaint and event intake form templates
• Roles and responsibilities matrix
• Editable in Microsoft Word and Google Docs

Who This Is For

• Medical device manufacturers subject to FDA MDR requirements
• Quality and regulatory affairs teams managing post-market surveillance
• Startups preparing for FDA registration and first inspections

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