ISO 13485 (Clause 7.3) - Design Verification Test Result Master Sheet
ISO 13485 (Clause 7.3) - Design Verification Test Result Master Sheet
Template Overview
Template Overview
Streamline your design verification process with our ISO 13485:2016 Clause 7.3 Design Verification Test Result Master Sheet Template. Design verification ensures that your medical device meets specified design inputs before moving to validation and production. This comprehensive master sheet helps manufacturers document and track verification tests efficiently, ensuring full regulatory compliance with ISO 13485:2016, FDA 21 CFR Part 820.30, MDR, and IVDR.
Key Features
Key Features
✔ Pre-Formatted Verification Test Result Master Sheet – Covers key ISO 13485:2016 Clause 7.3 requirements.
✔ Test Plan & Objective Tracking – Clearly define test purposes and design input references.
✔ Test Methods & Criteria Section – Standardize verification testing procedures.
✔ Pass/Fail Status & Non-Conformance Logging – Track all test outcomes with justifications.
✔ Risk Management & Failure Analysis Columns – Integrate with ISO 14971 risk management processes.
✔ Regulatory Compliance Section – Align verification activities with MDR, IVDR, and FDA standards.
✔ Approval & Sign-Off Workflow – Ensure verification activities are properly reviewed and authorized.
✔ Editable Spreadsheet Format – Fully customizable for different medical device classifications and testing needs.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use master sheet is ideal for R&D teams, quality managers, and regulatory professionals, ensuring a structured, compliant, and efficient design verification process.
Download the ISO 13485:2016 Design Verification Test Result Master Sheet Template today and simplify verification tracking!
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Additional information
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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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