Medical Equipment

Limiting the Scope of Recalls

Medical Equipment

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. It is expected that juridictions will soon impose micro-device identification and labeling. It is currently difficult to label micro-chip. Digitho is the only solution that can label micro-chip in a most durable way, in a cost effective way and with compatibility with semiconductor processes

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 secrecy in supply chain assets, as well as maintaining accurate device history tracking

The solution is resilient from Fabrication to End of Life.