Core engineering and protocols for IEC 62304 Class C Safety Architecture.
In Class C medical devices (e.g., cardiac pacemakers, automated insulin delivery systems, mechanical ventilators), a cybersecurity check must never delay life-saving therapy. MedicalTPM employs strict hardware bus partitioning: the cryptographic core runs on an isolated micro-engine with dedicated memory, communicating with the therapy controller via unidirectional status registers.
If an unconscious patient arrives at an emergency department with an encrypted medical implant and network connectivity is unavailable, authorized medical staff can activate a physical 'break-glass' magnetic or RF trigger. The device safely transitions to standard emergency pacing or basal delivery mode while logging the event in tamper-evident memory.