Medical Device Design Controls are a set of product development processes and procedures that manufacturers of medical devices must comply with to ensure that their products are safe and effective for their intended use.

The process is used to confirm that a medical device meets the user needs and intended uses. The EU medical device regulation enforces design control requirements through ISO 13485, which is an international standard for quality management systems, while the FDA enforces Design Control requirements through 21 CFR part 820.

We support the development of new medical device products throughout the entire development phase from project initiation to design transfer. As well as maintenance of existing documentation: Device Risk Management, Usability Engineering, Design input/output & Design Verification and validation.