UDI Compliance (Audit-Trail & Compliant Software) The implementation of the UDI system worldwide poses a challenge for manufacturers to comply with Unique Device Identification regulations. These obligations are multifaceted and…
UDI Barcode & Correct UDI Labeling Identification and traceability of medical devices are crucial factors for patient safety and efficiency in the medical device industry supply chain. In this context,…
Test your knowledge about UDI with our interactive quiz! What is UDI? UDI plays a crucial role in the traceability of medical devices to ensure safety and compliance. But how…
What sanctions are there for non-compliance with UDI requirements? Compliance with Unique Device Identification (UDI) requirements is not only crucial for companies in the MedTech sector but is also accompanied…
"Maximum number of reuses of device" in EUDAMED The implementation of Unique Device Identification (UDI) means that medical device manufacturers are obliged to provide health authorities such as the EUDAMED…
"Market Information": Meaning and Integration in EUDAMED The implementation of Unique Device Identification (UDI) means that medical device manufacturers are obliged to provide health authorities such as the FDA or…
Significant EUDAMED Update: New Timeline Heads up, everyone! There's been a shift in plans. EUDAMED's full functionality is now slated for Q2 2027. In late October 2023, the European Commission…
Dive with us into the world of Unique Device Identification (UDI) and discover how to overcome regulatory challenges and successfully implement efficient processes in your organization. Our upcoming webinar will…
Clinical Size Types : Meaning and integration in EUDAMED The introduction of Unique Device Identification (UDI) has resulted in medical device manufacturers being required to provide health authorities such as…
Storage & Handling Condition: Key aspects and their significance The ever-evolving medical device industry is subject to comprehensive guidelines designed to ensure the safety and efficacy of healthcare products. With…