Medical Technology Labeling Solution
Regulations and Standards
Regulations and Standards in North America require labelling for medical devices and traceability of components.
Labelling at the Die Level by Digitho
Digitho is the only solution that can label micro-chip most durably, cost-effectively and with compatibility with semiconductor processes.
FDA & Other Government Regulations
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.
Datamatrix: One Solution Fits All
Digitho offers a unique solution enabling the labelling and traceability of semiconductors at the unit level with a unique 2D code (DataMatrix).
Advantage of 2D code in Medical Devices
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.
Semiconductors in Medtech
The regulation in Medical Technology requires the supplier to label each component. However, the increase in the use and function of semiconductors is forcing the industry to rethink its approach to labelling. In addition, some testing type of semiconductors demands Unit Level Traceability, as in the case of Fluidics.
