The problem
What today's M2M auth can't deliver in medical implants.
Implantable medical devices have operational lifetimes measured in decades. The authentication scheme that ships in firmware must outlast every PKI authority the manufacturer relies on today and survive the post-quantum migration. Existing implant authentication relies on PKI under the manufacturer authority and does not provide cryptographic resistance to clone-and-replay attacks against captured devices.
How EdSSA addresses it
What EdSSA does differently here.
EdSSA Nano provides authenticated firmware update and clinician-to-device authentication that does not depend on a manufacturer-controlled PKI authority. Hardware-bound identity resists clone and replay. The cryptographic state evolves forward through one-way functions only — once advanced, it cannot be rolled back, even by a captured device.
Use cases
Concrete operational scenarios.
- Authenticated firmware update for pacemakers, neurostimulators, and insulin pumps
- Clinician-to-device authentication during clinical follow-up
- Telemetry authentication from implant to patient-side relay
- Manufacturer-independent authentication that survives the manufacturer's organisational lifecycle
Compliance & standards
Standards and regulatory regimes.
FDA pre-market cybersecurity guidance. EU MDR. IEC 62304 / IEC 81001-5-1. ISO 14971 risk management. NIST FIPS 203 alignment.
Audit emission
Audit logging compatible with FDA 21 CFR Part 11 and EU MDR audit requirements for authenticated firmware update events. Configurable from minimal-overhead production logging to full forensic trace.
Customers
Operators in this vertical.
“Implant authentication that does not depend on the manufacturer's organisational lifecycle. The twenty-year horizon stops being a worry.”