Certifications

At AB ANALITICA, the quality of our services and products is an absolute priority.

We are constantly committed to ensuring the highest quality standards in the industry, in order to provide products and services that contribute to the well-being of people and the progress of medicine.

To guarantee the quality of our certifications and medical devices, we rely on TÜV SÜD, an internationally renowned Notified Body with identification number 0123. This collaboration ensures compliance with the highest standards in the industry.

Quality

AB ANALITICA is certified according to the UNI EN ISO 9001 standard, which certifies the adoption of rigorous quality management standards in processes, services and products.

AB ANALITICA is also certified UNI CEI EN ISO 13485, which confirms the competence in the design, development, production and marketing of in vitro medical diagnostic devices (IVD). This specific standard is essential to guarantee the safety and efficacy of devices used in the medical field.

Finally, AB ANALITICA has obtained the certification in compliance with Article 10(8) of Regulation (EU) 2017/746 (IVDR), relating to in vitro diagnostic medical devices. This recognition certifies our compliance with European regulations governing the sector.