Core clinical engineering and protocols for Automated DHR & UDI Tracking.
Both FDA 21 CFR 820 and EU MDR Annex IX mandate that manufacturers maintain complete traceability for every individual device produced—from raw silicon component batches to deployed firmware versions and clinical installation sites.
IoMTOps automatically logs every firmware flash, configuration change, and field repair to an immutable, cryptographically verifiable Device History Record (DHR). In the event of a component recall, operators can identify exact patient devices in seconds rather than weeks.