Our recently won contracts from multiple medical device companies (from startups to billion dollar global companies) have more than helped us prove ourselves as experts in the field. As well, they have readied us for the potential troubles experienced by many startup medical device companies, such as finalizing their products to become FDA (Food & Drug Administration) certified and pass SEA (Software Engineering & Applications) regulations.
Recently, the medical industry has implemented changes intended to more strictly regulate itself. Specifically, the SEA has incorporated many aspects of DO-178 into its new requirements, and is demanding greater traceability and independence for FDA approval and certification.
For over 25 years, General Digital’s Software Engineering Services business unit has supplied IV&V (Independent Verification and Validation) services to the aerospace industry in compliance with DO-178 standards for safety-critical software. Our unrivaled experience performing manual and automated testing of life and mission-critical systems, as well as the qualification of the toolsets used to perform testing, has made General Digital a leader in the software testing field. This intimate knowledge of DO-178 requirements will allow us to seamlessly apply our unique talents to the medical market, and position ourselves as the subject matter experts to provide consultative services and testing. We are uniquely qualified to help our customers better understand the certification requirements, as well as perform IV&V services and provide software development.
Whether our customer is developing a new product, or attempting to retrofit/recertify a legacy solution, General Digital’s experienced staff provides the independent assessments necessary to obtain complete and accurate high quality software requirements, as well as help its customers meet the ever changing and more demanding requirements of the medical marketplace.