ISO 13485 (Clause 7.3) - Design Validation Test Report Template

Validate your medical device design efficiently with our ISO 13485:2016 Clause 7.3 Design Validation Test Report Template. Design validation is a critical step in ensuring that the final product meets user needs, intended purpose, and regulatory requirements before market release. This structured template helps manufacturers document and manage the design validation process, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820.30, MDR, and IVDR.

✔ Pre-Formatted Design Validation Test Report – Covers key ISO 13485:2016 Clause 7.3 requirements.

✔ Test Objectives & Scope Section – Define the purpose of validation activities.

✔ Test Methods & Acceptance Criteria – Ensure structured and reproducible validation testing.

✔ Test Execution & Results Documentation – Record outcomes with pass/fail status.

✔ Risk Management & Failure Analysis – Align with ISO 14971 risk management principles.

✔ Regulatory Compliance Verification – Confirm validation meets MDR, IVDR, and FDA standards.

✔ Approval & Sign-Off Section – Ensure traceability with proper documentation.

✔ Editable Digital Format – Fully customizable for different device classifications and validation needs.

This ready-to-use validation report template is ideal for R&D teams, quality managers, and regulatory professionals, ensuring efficient, structured, and audit-ready validation testing.

Download the ISO 13485:2016 Design Validation Test Report Template today and ensure compliant, risk-free product validation!