Design controls

Design Controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. Medical devices).

Medical devices

Since 1990, the Food and Drug Administration (FDA) has required that medical device manufacturers that want to market medical devices in the USA follow Design Control requirements (21 CFR 820.30). At a high level, this regulation requires:

• Establishment of an intended use and design inputs
• A design plan
• Periodic design reviews throughout the design process
• Confirmation that the design outputs conform to the design inputs through:

• Design verification ("did we design the device right?")
• Design validation ("did we design the right device?")

• Translation of the design into manufacturable specifications
• Clear documentation of the entire process in a design history file or DHF.

The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device.

ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC.

The objective of Design Controls, in this context, is to require that manufacturers follow a methodologically-sound process to develop a medical device, with the intent of improving the probability that the device will reach an acceptable level of efficacy and safety.

DESIGN CONTROL: Any Organization utilizes the design control process as a key part of the product realization process for all products. These activities may vary depending on the product Division, and if the products are manufactured in house, contract manufactured, or private labeled by another manufacturer. The Design Control process shall be controlled and documented per established procedures. An integral part of any Organization’s product development process is assuring that appropriate quality objectives and requirements are established, and that risk analysis is performed during the process to assure potential risks are addressed and minimized, either through design of the product or thru the product labeling process.

Design Inputs are established via customer feedback, customer input, market research or other methods and are an integral part of establishing the product requirements relating to function, safety, performance, and design. This includes a review and, where appropriate, filing of regulatory documentation. Risk assessment shall be performed to assure the product design or labeling adequately addresses and minimizes or eliminates potential risks.

Design Outputs: Are reviewed to assure all the requirements established during the design input phase have been met or addressed. This includes verifying the establishment of production, purchasing, and inspection systems, vendor or supplier qualification, approval of final product design (drawings, specifications, etc.) and other requirements as established in the Design Control Procedure(s).

Design Review is conducted at intervals during the product realization process to assure that the design meets requirements, identify and address any potential problems (including those in regulatory, material, manufacturing, supplier or other areas) and to if required, implement necessary changes under Organization’s Change Control Process.

Design Verification is performed to assure that the design and development process outputs meet the requirements established during the design input and development stages.

Design Validation is performed to ensure the end product is capable of meeting the requirements for it’s intended use. This can include clinical review, simulated use testing, customer evaluation or other methods. The final product will not be transferred to production until all required design verification and validation processes are complete.

Design Transfer: Once the final design is completed, the design will be transferred to production scale (this may be performed via the contract manufacturing process as well. The design transfer will be closely monitored to assure that the transfer goes smoothly and is properly transferred into production specifications.

Design Changes: Any changes to a new or existing design are handled such that design changes are documented, reviewed, validated and verified prior to full scale implementation.

Design History File: The documentation developed by the design process shall be compiled into a final Design History File for each type of device. The file contains and/or refers to the documentation that shows the product was developed in accordance with the approved design plan and inputs.

References and external links

• 21 CFR 820.30 on the FDA website [1]