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The FDA views the purpose of design controls as stated in the following reference from the Design Control Guidance document:

“Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances. Design controls make systematic assessment of the design an integral part of development. As a result, deficiencies in design input requirements, and discrepancies between the proposed designs and requirements, are made evident and corrected earlier in the development process. Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.

In practice, design controls provide managers and designers with improved visibility of the design process. With improved visibility, managers are empowered to more effectively direct the design process-that is, to recognize problems earlier, make corrections, and adjust resource allocations. Designers benefit both by enhanced understanding of the degree of conformance of a design to user and patient needs, and by improved communications and coordination among all participants in the process.

The medical device industry encompasses a wide range of technologies and applications, ranging from simple hand tools to complex computer-controlled surgical machines, from implantable screws to artificial organs, from blood-glucose test strips to diagnostic imaging systems and laboratory test equipment. These devices are manufactured by companies varying in size and structure, methods of design and development, and methods of management. These factors significantly influence how design controls are actually applied. Given this diversity, this guidance does not suggest particular methods of implementation, and therefore, must not be used to assess compliance with the quality system requirements. Rather, the intent is to expand upon the distilled language of the quality system requirements with practical explanations and examples of design control principles. Armed with this basic knowledge, manufacturers can and should seek out technology-specific guidance on applying design controls to their particular situation.

When using this guidance, there could be a tendency to focus only on the time and effort required in developing and incorporating the controls into the design process. However, readers should keep in mind the intrinsic value of design controls as well. It is a well-established fact that the cost to correct design errors is lower when errors are detected early in the design and development process. Large and small companies that have achieved quality systems certification under ISO 9001 cite improvements in productivity, product quality, customer satisfaction, and company competitiveness. Additional benefits are described in comments received from a quality assurance manager of a medical device firm regarding the value of a properly documented design control system:

 "...there are benefits to an organization and the quality improvement of an organization by having a written design control system. By defining this system on paper, a corporation allows all its employees to understand the requirements, the process, and expectations of design and how the quality of design is assured and perceived by the system. It also provides a baseline to review the system periodically for further improvements based on history, problems, and failures of the system (not the product)."

 (FDA D.C. Guidance, 2015)

The Quality Systems Regulation Preamble states:

Subpart C

“With respect to the new regulation, FDA believes that it is reasonable to expect manufacturers who design medical devices to develop the designs in conformance with design control requirements and that adhering to such requirements is necessary to adequately protect the public from potentially harmful devices. The design control requirements are basic controls needed to ensure that the device being designed will perform as intended when produced for commercial distribution.” (FDA Preamble, 2015)

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