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FDA UDI, DSCSA, and Quality Systems — Blockchain for Medical Device Manufacturers — FDA UDI, DSCSA, and Quality Systems
Medical device manufacturers face layered FDA compliance requirements — UDI registration, quality system records, and adverse event reporting — that blockchain-based quality management systems can satisfy more efficiently than paper-based alternatives.
contract MedicalDeviceRegistry { struct DeviceRecord { string udi; // FDA-assigned UDI string deviceName; string manufacturer; string lotNumber; uint256 manufacturingDate; uint256 expirationDate; bool recalled; string recallCode; bytes32 qualityCertHash; // IPFS: ISO 13485 certificate } mapping(string => DeviceRecord)...
Common integrations: The Graph, Alchemy/Infura, OpenZeppelin Defender, and popular wallet providers.
Clarify requirements, compliance needs, architecture risks, and launch goals.
Implement core contracts, integrations, product flows, tests, and deployment automation.
Run QA, prepare audit handoff, deploy infrastructure, and support production rollout.
No — FDA mandates UDI registration in the Global UDI Database (GUDID) which is FDA-operated, not blockchain-based. Blockchain adds a supplementary layer that manufacturers, hospitals, and distributors can use for supply chain tracking and adverse event investigation speed, beyond the minimum FDA requirement. The business case is operational efficiency and liability management, not regulatory mandate.
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