Design Control Procedure Bundle | ISO 13485 | FDA QMSR
The ISO 13485:2016 Design Control Procedure Bundle includes design control and related procedures that adhere to the design control requirements of ISO 13485:2016 and FDA QMSR.
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ISO 13485:2016 Design Control Procedure Bundle
The Design Control Procedure Bundle includes four (4) commonly purchased design control standard operating procedures drafted in accordance with ISO 13485:2016 and FDA 21 CFR Part 820.
ISO 13485:2016 Design Control Procedure Bundle Contents
The ISO 13485:2016 Design Control Procedure Bundle includes:
Design Control Procedure - The Design Control Procedure defines a systematic approach to product design to support compliance with applicable standards and regulations.
Design Review Procedure -The Design Review Procedure is centered on the systematic review of new product design, extensions to existing lines, and design modifications requiring design control. Includes Design Review Forms.
Design Transfer Procedure -The Design Transfer Procedure provides instruction on the transfer of medical devices from design and development to manufacturing.
Design Verification and Validation Procedure -The Design Verification and Validation Procedure addresses the design verification and validation elements of the design and development cycle.
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.
