ISO 13485 (Clause 7.3) - Design Change Plan Template

Comply with ISO 13485:2016 Clause 7.3 – Design & Development by implementing a structured Design Change Plan for medical device modifications. Our Design Change Plan Template provides a standardized framework for planning, evaluating, and implementing design changes while ensuring full regulatory compliance and risk management.

✔ Pre-Formatted Design Change Plan – Covers key ISO 13485:2016 Clause 7.3 and FDA 21 CFR Part 820.30 requirements.

✔ Scope & Objectives Section – Define the purpose and extent of the design change.

✔ Impact Assessment & Risk Analysis – Evaluate effects on safety, performance, and compliance.

✔ Verification & Validation (V&V) Strategy – Plan testing and documentation updates.

✔ Regulatory Impact Evaluation – Ensure compliance with MDR, IVDR, and FDA guidelines.

✔ Roles & Responsibilities Section – Assign key tasks to design, quality, and regulatory teams.

✔ Traceability & Documentation Control – Maintain full compliance with the Design History File (DHF).

✔ Editable Digital Format – Fully customizable to align with different device classifications and company processes.

This ready-to-use template is essential for R&D teams, quality managers, and regulatory professionals, ensuring a well-planned, compliant, and efficient design change process.

Download the ISO 13485:2016 Design Change Plan Template today and ensure structured design modifications!