Medical Device Design Control Procedure Template – QMSR Compatible

QMSR Compatible Design Control Procedure Template

Design Controls are among the most complex and most cited FDA requirements. This template walks your team through every phase of the design process — from planning through transfer — with a structured, audit-ready procedure compatible with QMSR (21 CFR Part 820) and ISO 13485:2016.

What's Included

• Complete Design Control procedure compatible with QMSR and ISO 13485
• Design planning, input, output, review, verification, and validation templates
• Design History File (DHF) structure guidance
• Design transfer and change control integration
• Editable in Microsoft Word and Google Docs

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