UDI - SISMA SPA
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Application note: UDI (Unique Device Identification) of medical devices according to MDR and FDA and Sisma solutions

UDI (Unique Device Identification) of medical devices according to MDR and FDA and Sisma solutions Increasing patient safety through medical device identification Patient safety is the first priority of both regulations and consistent labeling of each medical device is essential to maintain traceability and transparency throughout the whole supply chain, from the MD (medical device) manufacturer to the patient and across the entire product life cycle. In 2013, the FDA (Food and Drug Administration) released the Unique Device Identification (UDI) of medical devices directive. In 2017, the...

UDI standards UDI can be issued by accredited agencies in US (Health Industry Business Communications Council, International Council for Commonality in Blood Banking Application and GS1) or Notified bodies in EU. Each MD (and it’s own packaging) will have a UDI composed of two parts: a device identifier (UDI-DI) specific to a device, and a production identifier (UDI-PI) to identify the unit producing the device. - Required by many hospitals - only numeric data - Might need a big labelling area UDI can be applied as a 1D or 2D machine readable code and a human readable code. GS1 human...

Sisma turnkey solution for UDI medical marking SLC3 control software for Sisma laser machines offers unique features to make UDI traceability marking easier and safer. The UDI code is generated through manual or automated input, while the software constantly dialogues the company database via SQL queries. The software supports user levels with different authorizations; for instance, one user level is capable of setting up new projects while others can only recall existing ones and have limited or no access to process parameters. Four ways to load a UDI code SLC3 marks UDI codes in either 1D...

Thanks to CVS, Pattern Matching and server integration the machine takes care of: - Auto Focus by moving the Z axis XY position and rotation of the marking thanks Pattern matching software (maximum error ±0.02mm ) Marking the part in the correct position reporting to the internal database the marking results and correctness of the information Sisma automatic loading solutions for high productivity Process automation plays a huge role in the manufacturing of medical devices. Reducing errors and cycle time allows to reduce production costs and increase safety. The SART platform, with dial...