Design Control is an approach to systems development that supports systematic assessment of design as an integral part of development. It is a fundamental concept of the US Federal Food and Drug Administration (FDA) guidance for medical device manufacturers and is compatible with the requirements from other regulatory bodies. The FDA’s approach is documented in its Quality System Requirements, which are harmonized with ISO 13485:1996 (The FDA is updating this to the current version of the ISO 13485 standard, but we have no information on when this might be available). Design Control can be applied to any development approach or life cycle.

FDA Statements

The specific statements in the FDA Guidance are:

(a)General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

(2) The following class I devices are subject to design controls: (i) Devices automated with computer software; and (ii) The devices listed in the following chart.

Activities and Artifacts

Design Control consists of a number of activities and artifact types.

Activities: Design and Development Planning Review Design Verify Design Validate Design Transfer Design Manage Change

Artifact types: Design Input Design Output Design History File

Notice that many processes, for example those involved in creating Design Output, are not specified. Design Control leaves those up to the manufacturer to define. Design Control is concerned with ensuring that outcomes are appropriate, not with how they are produced. This is why it is independent of development life cycle.

The following figure shows how these fit together. The waterfall lifecycle is used merely as an exemplar:

The Design Process would generally have multiple levels (the highlighted blue box is recursive), the Design Output from one level is the Design Input to the next, until it is sufficiently refined to allow production of the device (or component of the device). Reviews potentially occur in all stages, for all artifacts (though the FDA Guidance only mandates one review. Validation is used to show that the delivered device satisfies the requirements and Verification shows that the Design Output satisfies the Design Input. This is shown at one level in the following figure:

See related material for details of the work products and tasks.

References

• FDA Design Control Guidance for Medical Device Manufacturers:
  • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm
  • http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf
• Section 820.30(a) of FDA Quality System Regulation
• ISO 9001:1994
• ISE/DIS 13485 Section 4.4.1 General