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 certain categories of 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.