How we can help with Unique Device Identification (UDI)

How we can help with Unique Device Identification (UDI)

FDA UDI affects your organization if you work in or supply medical device products to the USA... placing pressure on you to improve global labeling compliance.

The introduction of UDI aimed to offer a practical solution to positively identify medical devices from manufacture through to patient distribution, by presenting standard information in a standard format or barcode. To comply, you’ll need to include information set out by the FDA in human and machine-readable formats.

PRISYM 360 was built specifically for the life sciences industry, designed not only to meet existing regulations but flex to any upcoming challenges too. Our fully integrated, end-to-end labelling solution is designed to collate and sort centralized data (allowing only one source of the truth), print, and inspect labels for you to meet mandatory requirements such as UDI.

  • Achieve regulatory compliance
  • Robust audit capabilities
  • Skilled professional services team
UDI Lessons Learnt for EU MDR infographic - UDI Lessons Learnt. Embrace them for the EU MDR Implementation UDI Lessons Learnt. Embrace them for the EU MDR Implementation Posted in: Achieving Regulatory Compliance, Business Analysis, Increasing The Operational Efficiency, Infographic Archives, Information Technology, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance, Supply Chain -

The introduction of UDI requirements into the EU is good news for organizations that are already along the pathway of adopting systems and processes to support FDA UDI compliance.

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