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).

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.

Supplied as an editable Microsoft Word document as a digital download.

See the DESIGN PLUS Quality Management System

Part of a procedure bundle

This document is also included in Design Control Procedure Bundle. Explore the bundle for the related documents.