Medical Device and Avionics Software Testing Share A Common Goal
In the U.S. Avionics industry, software is categorized by its criticality and is certified by the Federal Aviation Authority (FAA). Similarly, in the Medical Devices industry, software is also categorized by its criticality and is certified by the Food and Drug Administration (FDA). Each of these federal agencies is governed by the Code of Federal Regulations (CFR). Avionics Software is covered in CFR Title 14 and Medical Software is covered in CFR Title 21.
In both cases, determining compliance to the regulations is based on evidence provided by the developers, following well-defined processes. At the core of the processes and subsequent evidence are software requirements. It’s well known in the software development field that the quality of the requirements plays a significant role in the success of the software product. But, how do you know you have high quality requirements? Both the FAA and the FDA say that Independent Verification and Validation (IV&V) is the answer.
IV&V is used to assess the accuracy of the requirements and the code. It answers questions such as, “Are the requirements complete?” and “Does the code meet the requirements?” The Independent in IV&V provides the basis for objectivity, which is critical during the review of software. This applies to both the medical device and avionics industries.
Our experienced software team tests to FAA standards DO-178 for the avionics industry, and tests to FDA standard IEC 62304 for the medical device industry. Both of these software standards address multiple levels of criticality to ensure the highest degree of safety for passengers and patients.
General Digital Software Services is the leader in high quality software testing and other verification services. We have been in the IV&V business for over 20 years. Many of our test engineers have long tenures with our team and have a broad range of experience with software verification. Whether it’s critical medical or avionics software, select the most qualified team to perform IV&V—select General Digital!
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