Since 1997, the FDA has required medical device manufacturers to follow design control requirements as stated in 21 CFR §820.30 for the design and development of devices marketed in the US.
Design controls are an integral part of making a medical device starting from the design plan through design transfer validation. If done well, design controls can protect patients and users by identifying problems in the development cycle and preventing a product redesign or potential recall downstream.
Design control requirements apply to FDA Class II and Class III medical devices, as well as a small number of low risk Class I Devices. In Canada and the European Union, medical devices must comply with the ISO 13485 design control requirements. Read our design control series for more information.
Although design controls for any device must be regimented and extensive, we have developed a simple and sensible design control process that utilizes templates and forms that a startup organization with limited stakeholders can implement.
Once established, our project managers can collaborate with you as little, or as much as you like, in implementing design controls. We can help author your design control deliverables or serve as independent reviewer along the way.