Design controls
Design controls are the application of a formal methodology to the conduct of product development activities.
It is often mandatory to implement such practice when designing and developing products within regulated industries.
Medical devices
Since 1990, the Food and Drug Administration has required that medical device manufacturers that want to market certain categories of medical devices in the USA follow Design Control requirements. At a high level, this regulation requires:- Design and development planning
- Design input, including intended use and user needs
- Design output, including evaluation of conformance to design input requirements through:
- * Design verification confirming that the design output meets the design input requirements
- * Design validation ensuring that the devices conform to defined user needs and intended uses
- Design review
- Design transfer ensuring that the device design is correctly translated into production specifications
- Design changes
- Design history file, a demonstration that the design was developed according to the approved design plan and 21 CFR 820.30.
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 either the IVDR or the MDR.
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 input
Examples of design input:| Device functions | Human factors |
| Physical characteristics | Labeling & packaging |
| Performance | Maintenance |
| Safety | Sterilization |
| Reliability | Compatibility |
| Performance standards | Environmental limits |
| Regulatory requirements |