Implementing the new quality system requirements: design controls.

To effectively implement the design controls required by Quality System regulation, medical device manufacturers need to structure and streamline their design and development process and integrate specific design controls at appropriate stages of the process. Procedures should be written and understood by all levels of the organization to ensure the adequate control of the design and development activities. These procedures should ensure that the following elements are part of the product development process: crossfunctional participation and coordination; precise and accurate user requirements; comprehensive and controlled design specifications; a plan to direct and control the product development activities; methods established to verify and validate the design; predetermined acceptance criteria and rationale; risk analysis and human factors engineering; formal change control and approval; documented traceability of design output to input requirements; qualification of components and sources; project control through effective leadership; multifunctional review; senior management involvement. Most important, medical device manufacturers must tailor the design control requirements of the Quality System regulation and the concepts presented in the Design Control Guidance to their specific needs. Practical consideration must be given to the technological complexity of their devices and the risks associated with the intended use of the devices. However, manufacturers must be in a position to defend the adequacy of the design controls they have implemented and to demonstrate their compliance with these controls. With respect to the enforcement of design control regulations, the FDA must ensure that investigators are adequately trained to provide a consistent and reasonable assessment of a manufacturer's process, methods, and procedures for design control.