ISO 13485 (Clause 7.3) - Design History Record Approvals Form Template
ISO 13485 (Clause 7.3) - Design History Record Approvals Form Template
Template Overview
Template Overview
Maintain compliance with ISO 13485:2016 Clause 7.3 – Design & Development by implementing a structured approach to Design History Records (DHR) approval. Our DHR Approval Form Template provides a standardized format for documenting, reviewing, and approving design changes, ensuring full traceability and regulatory readiness for medical device development.
Key Features
Key Features
✔ Pre-Formatted DHR Approval Form – Covers key ISO 13485:2016 Clause 7.3 and FDA 21 CFR Part 820.30 requirements.
✔ Design Change Documentation Section – Clearly record updates and modifications.
✔ Approval Workflow & Sign-Off Fields – Define roles for design, quality, and regulatory review.
✔ Verification & Validation (V&V) Section – Ensure proper assessment before implementation.
✔ Traceability & Record-Keeping Requirements – Maintain a compliant Design History File (DHF).
✔ Regulatory Compliance Checklist – Align with EU MDR, IVDR, and FDA requirements.
✔ Editable Digital Format – Fully customizable for different device classifications and design processes.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use approval form is essential for R&D teams, quality managers, and regulatory professionals, ensuring design changes are well-documented, approved, and audit-ready.
Download the ISO 13485:2016 DHR Approval Form Template today and strengthen your design control process!
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QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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