Medical device projects are very specialized, particularly if the device is FDA regulated. Great care must be taken in the planning, execution, and documentation of the software development process. At Gale Force we have been developing medical devices for many years and are experts at engineering firmware and software to meet IEC 62304, ISO 13485, FDA QSR 820 standards.
We often work as an extension of our clients' own product teams, but are equally comfortable taking a project from start to finish independently. For some clients with whom we are closely aligned, we serve as their complete technical product development team. We are accustomed to using our clients' quality system, or we can use our own internal, ISO-compliant quality system.