Design controls for medical device companies: 6 principles for success PDF guide

Since 1990, the FDA has required manufacturers of all class II and class III devices, and certain class I devices, to enact design controls, which represent a systematic approach to managing the end-to-end design of medical devices and SaMD solutions. Design controls are a set of procedures used to ensure that the design, development and production processes for medical devices meet regulatory requirements.

Organizations use these controls to ensure their design processes ultimately deliver products that work as intended and meet specific user needs in a compliant manner — and that design inputs and outputs are appropriate, with associated procedures thoroughly documented.