UDI Compliance
UDI-DI and UDI-PI assignment. GUDID (FDA) and EUDAMED (EU) database submission. GS1 and HIBCC formats.
Industries · Medical Devices
When your label is a regulated medical device component.
Medical device labeling is not marketing. It is a controlled output governed by FDA 21 CFR Part 801, EU MDR 2017/745, UDI requirements, and ISO 13485 quality systems. A labeling error here affects patient safety and market access.
FDA 21 CFR 801
Medical device labeling requirements. Content, format, and prominence rules for US market access.
EU MDR 2017/745
European Medical Device Regulation. Label content, language requirements, and conformity assessment.
Validated Templates
IQ/OQ/PQ validated label templates. Change control. Audit trail. Electronic signatures (21 CFR Part 11).
Serialization
Unique device identification per unit. Lot/batch coding. Expiry date management. GS1 and HIBCC formats.
SAP Integration
SAP ECC and S/4HANA integration for medical device labeling. Material master to label output governance.