Verification & Validation

Leveraging a Repeatable Process for Compliance

Our verification and validation team specializes in making medical devices compliant. Using a repeatable and proven process we are able to engineer a path forward targeting a successful submission the first time.

Ideally we work with a client early stage to define the V&V plan and strategy to consider how QA will be integrated into the development effort and managed to minimize test development and execution time. We understand the needs based on device class and software safety class and can tailor the plans appropriately to meet FDA requirements. We have experience using many requirements tracing tools and maintain licenses in our favorite tools to provide these benefits to our client.

We also can take devices, that were not originally designed to medical standards, compliant. It starts with a gap analysis between the current device design and the compliance requirements for the target market. The gap analysis includes a thorough review of the existing architecture, detailed design and implementation. Based on this gap analysis, we design a remediation plan focused on achieving compliance with minimal impact. The remediation plan includes a documented Verification test strategy with unit test procedures to ensure optimum test coverage.  We execute the unit test per the plan including organizing and managing the inspection reviews. We then organize all of the results and deliver the documentation to support your submission.