The global market for medical products is regulated by a range of national and international provisions and standards. The legal and regulatory requirements for medical products are complex, and the software that goes with them is constantly changing.
The quality of our products is very important to us. This is why we introduced systems for quality control ahead of time. This is the only way DIABASS® could succeed in the market for the past almost 25 years, and to grow continuously – longer than any other diabetes software.
We have had our quality-management system certified voluntarily by TÜV Süd in accordance with the strictest requirements of EN ISO 13485 for medical products. We are subject to audits at regular intervals.
Our medical products are developed in a regulated medical environment meet the standards outlined in ISO 13485.