Design Verification and Validation
Design verification and validation is a critical part of every medical device design project, and is required by the FDA and by ISO 13485:2016. By completing design verification, you confirm that design inputs were indeed met in the final design. And by completing design validation, you ensure that the final design meets user needs and intended uses. Planning, carrying out and documenting design verification and validation can be a cumbersome task but it doesn’t have to be. The engineers at Engineering & Quality Solutions, Inc. have extensive experience in completing design V&V for a variety of medical products. We can help your product development team with V&V from A to Z, whatever level your needs; you can hand off the project to EQS for full V&V planning, documentation and completion; or EQS can carry out some aspects of the V&V tasks as needed. Contact us today to discuss your design verification and validation needs.