Design Control Procedure Bundle | ISO 13485 | FDA QMSR
Coordinate medical device design and development with four editable procedures: Design Control, Design Review, Design Transfer, and Design Verification and Validation. The set supports phase planning and DHF records, independent reviews, documented verification and validation, and a controlled handoff to manufacturing.
Included procedures
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.
Four connected procedures
The bundle pairs Design Control with Design Review, Design Transfer, and Design Verification and Validation. Together they cover project phases, independent milestone reviews, the controlled handoff to manufacturing, and objective evidence that the design meets both specifications and intended-use needs.
What teams can implement
The Design Control document includes phase tasks and DHF structure; Design Review records decisions and open actions; Design Transfer provides a master transfer protocol and stage gates; and Verification and Validation establishes planned tests, acceptance criteria, results and deviations. Each document should be adapted to the device, organization and applicable market before approval.
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.
Supplied as editable Microsoft Word documents with related forms in a digital download.
Browse the individual documents in this bundle
Bundle value: The 4 included procedures total $596 when purchased individually at current prices. This bundle is $499, saving $97 (16%). Related forms are included as described above.
