ISO 13485 (Clause 7.3) - Design Change Record Template
ISO 13485 (Clause 7.3) - Design Change Record Template
Template Overview
Template Overview
Maintain compliance with ISO 13485:2016 Clause 7.3 – Design & Development by implementing a structured Design Change Record process. Our Design Change Record Template ensures that all modifications to a medical device’s design are properly documented, reviewed, and approved, providing full traceability for regulatory and quality compliance.
Key Features
Key Features
✔ Pre-Formatted Design Change Record – Covers key ISO 13485:2016 Clause 7.3 and FDA 21 CFR Part 820.30 requirements.
✔ Change Description & Justification Section – Clearly document what is changing and why.
✔ Risk Assessment & Impact Analysis – Evaluate effects on safety, performance, and compliance.
✔ Verification & Validation (V&V) Requirements – Define necessary testing and documentation updates.
✔ Approval Workflow & Sign-Off Sections – Ensure formal design, quality, and regulatory review.
✔ Traceability & Record-Keeping Requirements – Maintain compliance with Design History File (DHF) and Technical Documentation.
✔ Editable Digital Format – Fully customizable for different device classifications and regulatory needs.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use template is ideal for R&D teams, quality managers, and regulatory professionals, ensuring efficient, compliant, and well-documented design change management.
Download the ISO 13485:2016 Design Change Record Template today and simplify your design control process!
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About Patient Guard
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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