How systems architects structure decomposition, interface specifications, and risk controls for safety-critical Class C medical device software.
Under IEC 62304, software is assigned Class C if a failure could lead to death or serious injury. Class C requires the highest rigor of systems engineering: complete architectural segregation, exhaustive interface specifications, and dynamic testing of all software items.
How to design software boundaries (using process isolation, separate virtual machines, and memory-protected IPC) to demonstrate that lower-safety software items cannot adversely affect Class C items, allowing teams to limit the scope of high-cost verification.
Building automated traceability matrices connecting high-level system hazards (ISO 14971) to software architectural requirements, software detailed design specifications, and automated verification tests.