Design and Development Procedure - ISO 13485

Ensure a structured, traceable, and regulatory-compliant approach to medical device design and development with our ISO 13485:2016 Clause 7.3 Design & Development Procedure Template. A well-documented design and development process is critical for ensuring safety, effectiveness, and regulatory compliance in medical device manufacturing. This structured procedure template provides a step-by-step framework for planning, executing, and documenting design activities, ensuring compliance with ISO 13485:2016, MDR, IVDR, FDA 21 CFR Part 820, and ISO 14971.

✔ Pre-Formatted Design & Development Procedure – Covers key ISO 13485:2016 Clause 7.3 requirements.

✔ Design Planning & Risk Management Integration – Align development with ISO 14971 risk management principles.

✔ Design Input & Output Documentation – Define product requirements and expected performance criteria.

✔ Design Verification & Validation Processes – Ensure products meet specifications through testing and evaluation.

✔ Design Review & Approval Workflow – Assign responsibilities for milestone reviews and regulatory compliance.

✔ Change Management & Design History Tracking – Maintain full traceability of design modifications and decisions.

✔ Audit-Ready Documentation – Ensure structured records for regulatory inspections and QMS compliance.

✔ Editable Digital Format – Fully customizable for various medical device classifications and development models.

This ready-to-use design and development procedure template is ideal for R&D teams, quality managers, and regulatory professionals, ensuring a structured, compliant, and effective product development process.

Download the ISO 13485:2016 Design & Development Procedure Template today and enhance your innovation and compliance strategy!