ADVANCED MEDICAL EQUIPMENT S.A. has taken a key step bringing us closer to the start of series production and commercialization of the Diabetomat. The company has obtained ISO 13485:2016 certification, an international confirmation of the highest standards of the Quality Management System in the field of medical devices. The scope of the certification covers the full life cycle of our devices: from design, manufacturing and marketing, to service, training and secure data storage of IVD devices for exhaled breath biomarker analysis.
Our partners and future patients are guaranteed that all company processes are subject to rigorous control, ensuring reproducible quality, product safety and stable production. Structured procedures and regular monitoring of all stages of production create a solid foundation for future scaling of mass production and global distribution of Diabetomat.
