Eurofins Electric & Electronics Finland audits GlucoModicum-Sofio operations, with zero deviations.

GlucoModicum successfully completed an ISO 13485 audit conducted by Eurofins Electric & Electronics Finland, a qualified certification body which is designated by European Commission as a Notified Body according to the Medical Device Regulation (EU 2017/745 MDR) and In Vitro Diagnostic Medical Devices Regulation (EU 2017/746 IVDR).

The audit concluded with zero non-conformities and zero deviations, establishing a strong foundation for the final stages of the regulatory approval process.

Eurofins Electric & Electronics Finland is the Notified Body expected to oversee GlucoModicum’s CE marking process.