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World J Pediatr Congenit Heart Surg. 2012 Jan 1;3(1):77-81. doi: 10.1177/2150135111422720.

Design control requirements for medical device development.

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Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, USA.


Medical devices used in the United States must comply with federal regulations established to ensure that specified requirements have been met. The article will focus on 1 of 14 elements of the Quality System Regulation (QSR)-Design Controls. A high-level overview of these design control requirements is provided to increase awareness of the device development process and provide a basis for mutual understanding for continued dialogue with end users. Design control requirements were established by the US Food and Drug Administration (FDA) as an element of the QSR in 1996. Device manufacturers are required to have a quality management system (QMS) to ensure their devices are safe and effective. The QMS is established by writing operating procedures to achieve consistent application of the methods used to control quality and comply with regulatory requirements. The FDA has the responsibility to audit device manufacturers for compliance with the regulation. The requirements of the QSR and the resulting device design control procedures lend themselves to what is commonly known as the waterfall development process. This iterative process results in documented evidence that is defined in the QSR as the Design History File. This record of development is essential for managing the product life cycle. The elements and purpose of the design control process will be presented to illuminate today's development environment.


Collaboration between device developers and the practitioner is essential for improving clinical outcomes and reducing time to market of innovative devices.


collaboration; device; regulations; requirements

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