ISO 13485 (Clause 7.3) - Design Change Master Sheet Template
ISO 13485 (Clause 7.3) - Design Change Master Sheet Template
Template Overview
Template Overview
Maintain complete control over medical device design changes with our ISO 13485:2016 Clause 7.3 Design Change Master Sheet Template. This centralized tracking tool ensures that all design modifications are properly documented, reviewed, and approved, providing full traceability for regulatory compliance and quality management.
Key Features
Key Features
✔ Pre-Formatted Design Change Master Sheet – Covers key ISO 13485:2016 Clause 7.3 and FDA 21 CFR Part 820.30 requirements.
✔ Comprehensive Design Change Log – Track all design modifications, justifications, and approvals in one place.
✔ Risk Assessment & Impact Analysis Columns – Evaluate safety, performance, and compliance effects.
✔ Verification & Validation (V&V) Tracking – Document testing requirements and results.
✔ Regulatory Impact & Approval Workflow – Ensure compliance with MDR, IVDR, and FDA requirements.
✔ Traceability & Documentation Control – Link changes to the Design History File (DHF).
✔ Editable Spreadsheet Format – Fully customizable for different device classifications and company processes.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use master sheet template is essential for R&D teams, quality managers, and regulatory professionals, providing an efficient, structured, and compliant way to manage design changes.
Download the ISO 13485:2016 Design Change Master Sheet Template today and ensure seamless design change tracking!
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Additional information
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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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For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.