ISO 13485 (Clause 7.3) - Design Verification Plan Template

Ensure a structured and regulatory-compliant approach to design verification with our ISO 13485:2016 Clause 7.3 Design Verification Plan Template. Design verification is a critical step in confirming that medical device design outputs meet specified design inputs, ensuring safety, performance, and compliance with ISO 13485:2016, FDA 21 CFR Part 820.30, MDR, and IVDR.

✔ Pre-Formatted Design Verification Plan – Aligned with ISO 13485:2016 Clause 7.3 requirements.

✔ Verification Objectives & Scope Section – Define the purpose and extent of the verification process.

✔ Test Methods & Acceptance Criteria – Establish clear requirements for evaluating compliance.

✔ Risk Management & Traceability Links – Integrate with ISO 14971 risk management and Design History File (DHF).

✔ Verification Responsibilities & Workflow – Assign roles to design, quality, and regulatory teams.

✔ Regulatory Compliance Checklist – Ensure alignment with MDR, IVDR, and FDA standards.

✔ Approval & Sign-Off Section – Maintain full documentation and traceability for audits.

✔ Editable Digital Format – Fully customizable for different medical device classifications and testing strategies.

This ready-to-use verification plan template is ideal for R&D teams, quality managers, and regulatory professionals, ensuring an efficient, compliant, and structured design verification process.

Download the ISO 13485:2016 Design Verification Plan Template today and ensure seamless, audit-ready verification!