ISO 13485 (Clause 7.3) - Design Review Form Template

Ensure a systematic and compliant design review process with our ISO 13485:2016 Clause 7.3 Design Review Form Template. Design reviews are a crucial part of medical device development, allowing manufacturers to assess progress, identify risks, and verify compliance at each stage of the design process. This structured template ensures all design inputs, outputs, risk management, and regulatory requirements are properly reviewed and documented in alignment with ISO 13485:2016, FDA 21 CFR Part 820.30, MDR, and IVDR.

✔ Pre-Formatted Design Review Form – Covers key ISO 13485:2016 Clause 7.3 requirements.

✔ Review Stage & Meeting Details – Document critical design phases and review dates.

✔ Design Inputs & Outputs Assessment – Ensure compliance with requirements and specifications.

✔ Risk Management & Regulatory Considerations – Integrate with ISO 14971 and MDR/IVDR compliance.

✔ Action Items & Corrective Actions Log – Track follow-ups and resolutions.

✔ Approval & Sign-Off Section – Assign responsibilities and maintain traceability.

✔ Editable Digital Format – Fully customizable for different medical device classifications and development phases.

This ready-to-use design review form is ideal for R&D teams, quality managers, and regulatory professionals, ensuring structured, compliant, and audit-ready design evaluations.

Download the ISO 13485:2016 Design Review Form Template today and strengthen your design control process!