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.
FDA
Medical device manufacturers must incorporate in their quality assurance (QA) program several elements that relate to labeling in order to meet the Good Manufacturing Practice (GMP) requirements of the Quality System regulation
Health Canada
The identifier of the device, including the identifier of any medical device that is part of a system, medical device group, medical device family or medical device group family
European Medicines Agency
A Label on each Semiconductor
Regulation & Standards
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.
Digitho's Solution
Digitho is the only solution that can label micro-chip most durably, cost-effectively 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).
