Development & Design
Specifications and documentation for verification and validation.
Verification and validation processes require the right documentation to take your concept to the next phase of development. You can end up with a lot of additional work if you aren’t aware of the requirements or if your documentation isn’t precise from the start.
Our experts understand the complexities of design verification and design validation and can help you determine the appropriate level required by industry regulations, like 21 CFR 820, to get your product approved and on the market. We think about these considerations early in the design and development phases and document along the way so we can quickly and seamlessly move from development to verification and validation.
Our engineers know how to make sure you don’t miss any of the details so you can avoid pitfalls that slow down the product development process.
Having the appropriate records organized and the right plans in place from the start will make the approval process easier.
Our experts understand the industry regulations and know how they are applicable to your medical device, so you are prepared for the right approval process.