Design Control Procedure | ISO 13485 | FDA QMSR
The Design Control Procedure provides a phase-by-phase framework for medical device development, from concept and feasibility through verification, validation and launch. It assigns design tasks, review points and records, including the Design History File (DHF).
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Supplied as one editable Microsoft Word document in a digital download.
Project life cycle and starting point
The 33-page Design Control Procedure sets out a project life cycle from concept and feasibility through design inputs, design verification, design validation, launch and product maintenance. A project may enter at different points depending on whether it is a new device, a line extension or a change to an existing product. Its life-cycle table also distinguishes when the engineering-change route is appropriate.
Phase-by-phase work
Concept work can include customer needs, early models, exploratory prototypes and a preliminary plan. Feasibility develops the product and regulatory strategy, initial risk analysis, preliminary specifications and the development plan. The design-input phase turns these into approved, reviewable requirements. Verification then compares outputs with inputs; validation evaluates the finished design against intended use and user needs before launch.
Project controls and included guides
The document assigns departmental tasks and review gates, describes creation and maintenance of the Design History File (DHF), and provides phase task checklists for concept, feasibility, inputs, verification, validation and launch. Later attachments include a DHF content guide, usability-engineering file guidance, product approval and DHF closure forms. A separate flow chart illustrates project decisions and records.
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.
For the related stage records, see the Design Review Procedure, Design Verification and Validation Procedure, and Design Transfer Procedure.
See the DESIGN PLUS Quality Management System
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Design Controls: Requirements, Reviews and Transfer for workflow guidance, a checklist and common mistakes.
Part of a procedure bundle
This document is also included in Design Control Procedure Bundle. Explore the bundle for the related documents.
