Quality & Certifications
Quality is the heart of our performance
We are committed to ensure the highest quality standards for all our products and services, through a planned system of Quality Assurance Management, that covers every part of our business.
Regular quality performance reviews and audits are essential parts of this system, aiming to continuous improvement. Diatheva has a GMP compliant manufacturing facility authorized by AIFA for the production of both Active Pharmaceutical Ingredients (APIs) and Sterile medicinal products for human use.
Moreover, Diatheva Quality Management System complies with UNI EN ISO 9001:2015, UNI EN ISO 13485:2021, and European Regulation 2017/746 (IVDR), to ensure the provision of both products and services which consistently meet customer expectations, and in vitro medical devices able to ensure patient and user safety and meet the requirements of industry regulations.
Certificates of GMP compliance of a manufacturer
Diatheva S.r.l.
Certificates No: IT-API/42/H/2025 IT/163H/2023
Design and development, production and sales of in vitro diagnostic reagents for infectious disease
ISO 13485:2021 Certificate No: Q5 120916 0001
Design and product of recombinant proteins, antibodies, molecular biology & immunoenzymatic kits
ISO 9001:2015 Certificate No: IT05/0576
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