We have adapted to medical
technology.
With us, you can combine the digitization of your business processes with support in regulatory matters (e.g., DIN EN ISO 13485, MDR, 21CFR820). Special attention is also paid to the globally unique identification of medical devices with UDI (Unique Device Identification).
UDI is already in use in the US and is now being introduced in Europe together with the new EU Medical Devices Regulation (EUDAMED database). These requirements are already being implemented with our industry-specific solution for ERP software for medical technology/UDI from oxaion.
UDI
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Full functionality in accordance with MDR and FDA for medical devices and IVDs
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Management of all relevant master data in oxaion and provision for registration with the FDA and EUDAMED
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GS1 and HIBC formats are supported
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Easy XML export for GUDID and EUDAMED databases
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Basic UDI-DI, GTIN, and GLN management
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Configurable UDI and generation of the necessary information for the graphical UDI label
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Management of third-party UDI
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UDI for external manufacturing, in the device file, and on various documents
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Package DI / UDI
Electronic Signature
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Compliant with 21CFR820 part 11 for electronic signatures from the FDA
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Decoupled signatures including task and workflow control
Serial numbers & device file
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Documentation of the product lifecycle, including service orders, software versions, and serial number history
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Document assignment and traceability
audit trail
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Traceability of regulatory-relevant changes
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Including documentation of change comments
CAQ
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Quality control for incoming goods, production-accompanying testing, and outgoing goods, test equipment management
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Quality management, including complaints, CAPA, measures, audits, etc.
