FDA QMSR Design Control Policy, SOP & Forms

¥319,500

FDA QMSR Design Control Policy, SOP & Forms

FDA QMSR Design Control Policy, SOP & Forms

¥319,500

Design Control and DHF Management templates for FDA QMSR compliance.

Quantity

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✅ Common Features Across All QMS Templates

🇺🇸 FDA QMSR (21 CFR Part 820)
·
🌐 ISO 13485:2016 §7.3
·
📝 MS Word (.docx)
·
🔄 Immediate Use
·
🎬 Video Guidance on YouTube

Overview

A comprehensive design control template set for FDA QMSR compliance. Covers the complete design lifecycle—from planning and inputs through verification, validation, transfer, and DHF management—ensuring your medical devices meet all safety and regulatory requirements.

Regulatory Reference: ISO 13485:2016 §7.3 — Design and Development

Why You Need This

ISO 13485:2016 §7.3 mandates rigorous design and development controls. Design control deficiencies are a leading cause of FDA warning letters and product failures. This complete template set provides end-to-end coverage.

What’s Included

Document Type Description
📄 Policy Document 1 file — Organizational policy & management framework
📋 SOP / Procedure Design Control SOP
📋 SOP / Procedure DHF Management Policy QMSR
📋 SOP / Procedure DHF Management SOP QMSR
📋 SOP / Procedure MD-QMS-S404 Design Transfer Procedure
📝 Form / Template MD-QMS-F401 DHF DR Meeting Minutes
📝 Form / Template MD-QMS-F401 DR Meeting Minutes
📝 Form / Template MD-QMS-F402 DHF DR Follow-up Table
📝 Form / Template MD-QMS-F402 DR Follow-up Form
📝 Form / Template MD-QMS-F403 DHF DR Certification
📝 Form / Template MD-QMS-F403 DR Certification
📝 Form / Template MD-QMS-F405 Traceability Matrix
📝 Form / Template MD-QMS-F406 DHF Design Verification Approval
📝 Form / Template MD-QMS-F406 Design Verification Approval
📝 Form / Template MD-QMS-F410 DHF Design Input Approval
📝 Form / Template MD-QMS-F410 Design Input Approval
📝 Form / Template MD-QMS-F415 Basic Design Output Approval
📝 Form / Template MD-QMS-F415 DHF Design Output Approval Basic Design
📝 Form / Template MD-QMS-F416 DHF Design Output Approval Mass Production
📝 Form / Template MD-QMS-F416 Production Design Output Approval 1
📝 Form / Template MD-QMS-F420 DHF Design Transfer Record
📝 Form / Template MD-QMS-F420 Design Transfer Record
📝 Form / Template MD-QMS-F430 DHF Index Table of Contents
📝 Form / Template MD-QMS-F432 DHF Design Transfer Checklist

📋 Policy — Table of Contents

1. Purpose
2. Scope
3. Normative References
4. Definitions
5. Design Review Meetings
5.1 Design Review Process
5.2 Design Review Stages
5.3 Design Review Participants
5.4 Design Review Records
6. Medical Device Product Lifecycle
7. Design and Development File (DDF)
7.1 DDF Management
7.2 DDF Creation
7.3 DDF Approval
7.4 DDF Storage Location
7.5 DDF Required Contents
8. Deliverable Approvers
9. Record Retention
10. Corrective and Preventive Action (CAPA)
11. References
12. Supplementary Provisions

📋 Design Control SOP — Table of Contents

1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Basic Policy
6. Procedure
6.1 Business Planning Stage
6.1.1 New Product Concept Creation
6.1.2 Product Development Planning
6.2 Design and Development Planning Stage
6.2.1 Product Development Plan Creation
6.2.2 Risk Management Planning
6.2.3 New Product Development Planning Review (DR0)
6.3 Design Input Stage
6.3.1 Specification of User Requirements
6.3.2 Specification of Product Requirements
6.3.3 Risk Analysis Implementation
6.3.4 Usability Engineering Evaluation Implementation
6.3.5 Design Input Creation and Team Review
6.3.6 Traceability Matrix Initiation
6.3.7 Design Input Review (DR1)
6.4 Design Output Stage
6.4.1 Basic Design Step
6.4.2 Design Output Review (DR2-1)
6.4.3 Production Design Step
6.4.4 Design Output Review (DR2-2)
6.5 Design Verification
6.6 Process Design and Production Transfer Preparation
6.7 Design Validation
6.8 Design Transfer
6.8.1 Design Transfer Activities
6.8.2 Design Transfer Review (DR3)
6.8.3 Design Transfer Approval
6.9 Design Changes
7. Design and Development File (DDF)
7.1 DDF Creation
8. Record Retention
8.1 DDF Retention
8.2 MDF Retention
8.3 Retention Period
9. Corrective and Preventive Action
10. Forms
11. References
12. Supplementary Provisions

📋 DHF Management Policy QMSR — Table of Contents

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

📋 DHF Management SOP QMSR — Table of Contents

1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. Procedure 1: Design and Development
6. Procedure 2: DHF Creation
7. Procedure 3: Design Transfer
8. Procedure 4: DHF Approval
9. Forms
10. References
Supplementary Provisions

📋 MD-QMS-S404 Design Transfer Procedure — Table of Contents

1. Purpose
2. Scope
3. Definitions
4. Roles and Responsibilities
5. General Principles and Basic Rules
6. Procedure
6.1 Design Transfer Preparation (Process Design)
6.2 Design Validation
6.3 Design Transfer
6.4 Design Transfer Review (DR3 – Design Transfer Review Meeting)
6.5 Design Transfer Approval
7. Forms
8. References
9. Supplementary Provisions

Key Features

  • Fully aligned with ISO 13485:2016 §7.3 (Design and Development)
  • Written for immediate use — minimal customization required
  • Structured for FDA QMSR (21 CFR Part 820) compliance
  • Microsoft Word format (.docx) — easy to edit and adapt
  • Professional quality suitable for FDA inspection review
  • Includes all required procedural elements and record templates
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