Supply chain regulation guidance

Get prepared for the implementation of UDI

The new EU MDR and IVDR regulations (2017/745/EU and 2017/746/EU) bring fundamental changes in the identification of medicines and diagnostic devices. Get ready!

Implementation of new regulatory requirements of EU Medical Devices Regulation and EU In-Vitro Diagnostics Devices Regulation will affect your business as a whole, from data management to business processes.

Deadline is
May 26th 2020

We are ready to help

Benefit from our insights and experience. Our experts were among those who participated in creation of the new EU rules.

  • Define what products are in scope and how they are MDR classified
  • Review your current UDI compliance status regarding business processes (product development, sourcing, manufacturing, labelling, supply, sales), data management, and UDI roles and responsibilities.
  • Develop tailored UDI solution
  • Prepare you for inspection (according to ISO13485 & FDA standards)

Quick check

Fill a short questionnaire and find out your situation

Check compliance

Created in associaton with Jay Crowley, the vice president of Unique Device Identification Solutions and Services at USDM Life Science.

Partners

GS1 Germany

Globalworx is GS1‘s Solution Partner for identification and traceability solutions

Fanstel

Globalworx is an official distributor of IoT products by Fanstel

Clima Temperatur Systeme

Supplier of CTS climatic stress screening test cabinets

Bluetooth

Member of Bluetooth Special Interest Group (SIC)

USDM Life Sciences

UDI cooperation partner

Karavan Consulting

GDP cooperation partner

Xavier Health

GSP cooperation partner