Not on their own, no. However, by following good design controls relative to design inputs and design verification and validation, it is far more likely that you will design a safe and effective medical device. The effort put into design input requirements is time well spent. Ensuring that you consider all design input sources – post-market data for a similar design (yours or a competitor’s), human factors engineering, standards, FDA guidance, a predicate device’s specifications, the use environment, user need data from sales, marketing or post-market data, etc.- goes a long way to ensuring your device will be designed to the correct user needs and your intended uses.
 
Performing design verification activities to ensure you understand the reason for and appropriateness of your design output specifications (your specified design solutions). Performing design validation to ensure your device will perform and function as you intend and your user’s need. Design validation must be done on actual or production equivalent units and under actual or simulated use, including the use environment. Design validation should also be done within the range of your defined output solutions – across or at a minimum at the boundary limits of your defined tolerances.
 
The final step in ensuring you build a safe and effective medical device is performing good design transfer.  Manufacturability and serviceability is part of design. The design is something that can be manufactured to design specifications and that if serviced, the servicing will not alter the device from its design specifications.

Denise Dion is the vice-president, regulatory and quality services at EduQuest, where she provides advice and guidance regarding FDA's regulation of drugs, biologics, medical devices, and food.