When your product development team reaches the design verification stage, it may seem like you are very close to submitting a 510(k) application and getting your product approved. This could be true if you've done everything perfectly, but the design verification step holds higher stakes than most medical device companies realize at first. As part of design verification, medical device companies conduct various activities to ensure that the design outputs match the design inputs that were defined earlier in the design controls process. If the design outputs don't satisfy the requirements for your device, it's back to the drawing board. Even a successful design verification process can lead to problems - what if the design inputs were met, but user needs were inadequately captured? You'll have designed a device that doesn't work.
Design verification is just one element in the overall design controls process, a multi-step framework for ensuring that your medical device is safe and effective for the intended user. Like all such processes, the success of design verification depends on the success of the upstream processes that precede it. If your medical device company fails to accurately understand user needs, establish design inputs that satisfy to those user needs, and produce design outputs that reflect the defined inputs correctly, all of those errors could be revealed in the design verification step, and you could face a major setback on getting to market.
The FDA's guidance documents define verification as "confirmation by examination and provision of objective evidence that specified requirements have been fulfilled." When most engineers think of design verification, they think about "testing" - and they're right, design verification will involve some product testing. Here are a few common design verification activities across medical device companies:
Design verification is more than just conducting tests, however - you'll need to develop a design verification plan in conjunction with the development of your design inputs to ensure that you have a plan for ensuring that the design inputs are adequately satisfied.
It's easy to conflate the ideas of design verification and validation, but these are two separate processes that need to be treated as such. They can be easily differentiated as follows:
The trap here is that design validation happens very late in the design process while defining user needs is something that happens near the beginning. There needs to be clear continuity throughout the overall design controls process to ensure a successful design validation, and that's why the intermediary steps (design inputs and outputs, and design review and validation) are all so important.
Greenlight Guru's QMS Software offers a comprehensive solution for streamlining and managing your design controls process. Whether you're documenting user needs to be established at the beginning of your project, establishing design inputs, working on specifications for your product, or documenting the results of design verification testing, Greenlight Guru's QMS Software offers a secure platform for accessible storing and organizing all of your documented results.
The product development process can take weeks, months, or even years, and maintaining an organized and accessible trove of documents is crucial to establishing a compliant QMS, successfully working through the design controls process, and reducing your time-to-market. Medical device companies that try to establish a QMS after developing their product frequently find that they have lost or misplaced important documents relating to the design specifications of their device, and it becomes impossible to catch up with the missing documents within an acceptable time frame.
Greenlight Guru's QMS Software offers secure access to all of the documents needed for design verification, and that will eventually feed into your design history file and 510(k) submission - it's the best way to stay organized and ready for successful FDA submission that will speed up your time-to-market.