Medical Overview
Software assurance as it relates to medical systems and devices ensures completeness, safety, and reliability of software processes and products. With the growing trend towards convergence in portable systems and the advent of in-home medical applications, medical devices have become more sophisticated and complex. The software requirements in all aspects of the device design and development are more comprehensive, and the need for device manufacturers to have formalized software assurance processes is well established.
These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. All medical devices, including those with embedded software controls, go through a stringent testing and classification process that determines the applicable level of FDA regulation and approval necessary. Device manufacturers must reach a balance between the integration of new technology without compromising requirement for product safety and reliability.
Commercial-off-the-shelf
The technology trend in medical is found in COTS (commercial-off-the-shelf) solutions that offer a flexible choice of operating systems and processing platforms. For example, Linux may be appropriate for slower, non-life critical applications, while certifiable RTOSs (real-time operating systems) are being used in life critical systems where reliability and accuracy are paramount, such as robotics and diagnostics. ALT’s highly skilled teams of software engineers and program developers are extremely experienced at integrating the leading COTS RTOSs in the development of embedded 2D/3D and multimedia software products and services for medical devices.