MediShield Registry provides a secure, federated platform for healthcare providers to manage and share patient medical device implantation and recall data, complying with emerging global UDI (Unique Device Identification) regulations. It prevents patient harm from faulty devices and drastically reduces the administrative burden and legal exposure associated with tracking medical device lifecycles. This becomes indispensable as regulatory bodies mandate higher transparency and traceability for implanted devices.
The increasing complexity of medical devices, coupled with new regulatory mandates (e.g., FDA requiring UDI submission, EU MDR) and breakthroughs in secure multi-party computation and distributed ledger technologies, make a federated, auditable registry technically feasible and legally necessary now.
Hospital compliance officers, risk managers, medical device manufacturers, and regulatory bodies who face increasing fines and operational overhead for non-compliance with device traceability laws.
Subscription-based service per hospital system or medical device manufacturer, tiered by data volume, number of users, and advanced analytics/reporting features. Transaction fees for data sharing with patient consent.