Design Control and DHF Management templates for FDA QMSR compliance.
Preview before you buy: Download a watermarked sample PDF showing the cover, table of contents, and sample sections.
This editable Microsoft Word template set is fully aligned to FDA QMSR (21 CFR Part 820) §820.30 Design Controls and ISO 13485:2016 §7.3 Design and development.
What’s Included (DHF Management + Design Control bundle)
Policies
- 📄 DHF_Management_Policy_QMSR.docx
- 📄 Design_Control_Policy.docx
SOPs
- 📄 DHF_Management_SOP_QMSR.docx
- 📄 Design_Control_SOP.docx
- 📄 MD-QMS-S404_Design_Transfer_Procedure.docx
Forms (DR & DHF, ~20 files)
- 📄 F401 DR Meeting Minutes (DHF + standard versions)
- 📄 F402 DR Follow-up
- 📄 F403 DR Certification
- 📊 F405 Traceability Matrix (.docx + .xlsx)
- 📄 F406 Design Verification Approval
- 📄 F410 Design Input Approval
- 📄 F415 Basic Design Output Approval
- 📄 F416 Production/Mass Production Design Output Approval
- 📄 F420 Design Transfer Record
- 📄 F432 Design Transfer Checklist
Other
- 📄 MD-QMS-F430_DHF_Index_Table_of_Contents.docx
Table of Contents (Policy Document)
- 1. Purpose
- 2. Scope
- 3. Normative References
- 4. Definitions
- 5. DHF Management
- 6. DHF Creation
- 7. DHF Approval
- 8. DHF Storage Location
- 9. Documents and Records to be Included in DHF
- 9.1 Planning and Requirements Definition Stage
- 9.2 Design Planning Stage
- 9.3 Conceptual Design Stage
- 9.4 Detailed Design Stage
- 9.5 Design Verification Stage
- 9.6 Design Validation Stage
- 9.7 Design Transfer Stage
- 9.8 Additional Records Throughout All Stages
- 10. Design Change Control
- 10.1 Major Changes
- 10.2 Minor Changes
- 11. Residual Risk Acceptance Criteria
- 12. References
- 13. Supplementary Provisions
Aligned to 21 CFR Part 820 (QMSR) and ISO 13485:2016.
📄 Preview the Document Before You Buy
Confident purchase decisions start with knowing what’s inside. Download a watermarked sample showing the cover page, table of contents, and the first sections — so you can verify scope, structure, and language fit your QMS before adding to cart.
Table of Contents — FDA QMSR Design Control Policy, SOP & Forms
- Purpose
- Scope
- Definitions
- Roles and Responsibilities
- Procedure
- References
- Supplementary Provisions
4-page sample preview
Cover · TOC · Sample sections
Watermarked PDF
The sample is provided for evaluation only. Full editable Microsoft Word files (without watermark) are delivered immediately upon purchase. © eCompliance Ltd. — All rights reserved.
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