ISO 13485 (Clause 7.3) - Design Transfer Checklist Template

Ensure a structured and regulatory-compliant transition from design to manufacturing with our ISO 13485:2016 Clause 7.3 Design Transfer Checklist Template. The design transfer process is critical in ensuring that the final medical device meets regulatory, quality, and performance requirements before full-scale production. This comprehensive checklist helps manufacturers effectively manage and document the transfer process while ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA requirements.

✔ Pre-Formatted Design Transfer Checklist – Aligned with ISO 13485:2016 Clause 7.3 and FDA 21 CFR Part 820.30.

✔ Design Output Verification Section – Ensure all drawings, specifications, and materials are finalized.

✔ Manufacturing Process Readiness Assessment – Verify that processes, equipment, and controls are in place.

✔ Risk Management & Validation Steps – Ensure integration with ISO 14971 risk management.

✔ Regulatory & Compliance Verification – Confirm alignment with MDR, IVDR, and FDA standards.

✔ Documentation & Record-Keeping Requirements – Maintain a fully audit-ready process.

✔ Editable Digital Format – Fully customizable for different medical device classifications and company workflows.

This ready-to-use checklist is essential for R&D teams, quality managers, and regulatory professionals, ensuring an efficient, structured, and compliant design transfer process.

Download the ISO 13485:2016 Design Transfer Checklist Template today and ensure seamless, risk-free production readiness!