Design Control Procedure | ISO 13485 | FDA QMSR

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Design Control Procedure Overview

The Design Control Procedure identifies design tasks by phase, overall design considerations, action items and required testing (by phase). The Design Control Procedure outlines specific departmental tasks and responsibilities throughout product development. The Design Control Procedure provides instruction on the structure and content of Design History Files (DHF's). The Design Control Procedure provides the critical foundation to help design team manage all medical device design and development projects.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.