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 dagnostic 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.
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 are they MDR classified
- Review your current UDI compliance status regarding business processes (product development, sourcing, manufacturing, labelling, supply, sales), data management, and UDI roles and ressponsibilities.
- Develop tailored UDI solution
- Prepare you for inspection (according to ISO13485 & FDA standards)
Fill a short questionnaire and find out your situationCheck compliance
Created in associaton with Jay Crowley, the vice president of Unique Device Identification Solutions and Services at USDM Life Science.