Verification & Validation Services
Ensuring Quality and Safety in Every Product
Medical device design verification and validation provide assurance that the right product was designed and the design was implemented correctly. Full Spectrum's Verification engineers support the development of test strategies, applying appropriate statistical design to assure your products perform reliably in their intended use environments.
Systems and Performance Test Design & Execution
We develop a V&V plan that targets testing of systems function and performance, applying focus on verification design with the same rigor engineers use to design the product.
Software Verification & Validation
We utilize a structured test design process that applies the appropriate test method to provide assurance in software system testing, integration testing, and unit testing.
Environmental, Reliability & Usability Testing
We develop statistically-based tests, assuring your medical device performs in specified environments over the life of the product and driving formative strategy to support FDA's usability expectations.
Test Protocol and Test Case Execution & Reporting
We apply a testing process, including test protocols, test reporting, test execution techniques, and issue management, that meets regulatory expectations.
Product Change, Regression, Trace Matrix Maintenance
We help your team apply documentation approaches to assure sustainability and manage product improvement, correction, and obsolescence.