DIAPROF MED has successfully passed a recertification audit in order to confirm the conformity of products bearing the CE mark with the requirements of Directive 98/79 / EC of the Council of the European Union and the European Parliament on medical devices for in vitro diagnostics.
The compliance of the quality management system of DIAPROF MED with the requirements of ISO 13485: 2016 was also confirmed. The scope of the quality management system extends to the development, design, production, and sale of IFA test systems, their reagents, and control materials for the diagnosis of infectious diseases. During the audit, using the example of test systems for diagnosing COVID-19, the entire chain from development to post-marketing services was checked.
The audit was carried out by the international certification body MDC GmbH, Germany. DIAPROF MED "has confirmed its status as a reliable, responsible, socially-oriented company.