Traceability and Labelling in Medical Devices

Traceability at the die level

Regulations and Standards in North America require labelling for medical devices and traceability of components.

The FDA and Health Canada have specific requirements for Medical Devices, which differ regarding the type of device and function and the type of labelling. ​

Medical Device Tracking | FDA ​

Guidance for the Labelling of Medical Devices

Digitho offers a unique solution enabling the labelling and traceability of semiconductors at the unit level with a unique 2D code (DataMatrix). ​

The information carried with the 2D code is proprietary to the code's owner and can be shared at discretion with the stakeholders in the supply chain. Maintaining NDA or other confidentiality requirements

The solution is resilient from Fabrication to End of Life.​

All Right Reserved

Digitho Technologies Inc

Bromont QC Canada

Digitho is a partner of:

ISEQ, ACET, NEXTAI, Investissement Quebec, PARI CNRC, C2MI