Testing is critical in regulated industries, such as medical devices, and something to consider for all software projects. Before release of the software, product developers and manufacturers must be certain appropriate effort has been taken to ensure the safety of patients and end-users, as well as the reliability of the product. Regulatory standards such as IEC 62304 require both Verification and Validation to ensure the end product meets the design requirements and provides the desired value to the end-user. With deep expertise in regulated environments, Full Spectrum Software helps our clients meet both of these objectives.
Full Spectrum Software works with our clients to define an appropriate plan to demonstrate the software requirements have been met. Through a comprehensive traceability matrix, each product requirement is linked to one or more test protocols. These test protocols, organized as a set of use scenarios, are groups of steps designed to exercise the complete functionality of the software.
With an average of 15 years’ experience testing complex systems, our Quality Engineers employ the latest tools and technology to dig deep into the system under test to find bugs and prove it reliably meets the clients’ requirements.
Our testing services include:
Validation ensures the requirements meet the needs of the end-user. In some cases, our clients have their own product management and quality teams to ensure the product requirements meet their intended purpose. Other clients ask us to provide this service. In either scenario, our V&V team takes a deep look at the product from an end user’s perspective, asking if the product requirements make sense, given the product’s intended use.
Our team has broad and extensive experience with a wide range of software, devices, and embedded systems. We provide empirical data on the ease of use and how well the product meets the user’s needs.