QUALITY

Our customers are mainly the diagnostic industry and research facilities, therefore our processes are subject to legal guidelines, high qualitative and ethical standards. With the development of our products in 2002, we expanded the Marketing & Sales division and developed our quality management system. Since 2003 we have been certified according to DIN EN ISO 9001 and 2004 according to DIN EN ISO 13485 in the respective valid version. Through regular self-monitoring and external auditors, we continuously improve and expand our quality standards.

ETHICS

The in.vent is committed to the highest ethical standards and always observes the principles of the Declarations of Helsinki and Taipei as defined by the World Medical Association in all projects. Our medical cooperation partners are contractually committed to complying with and complying with these standards. Our projects are evaluated and evaluated by competent independent ethics committees and, if necessary, by the competent federal authority. In doing so, we take into account: the notes of the Federal Medical Association and the “Working Group of Medical Ethics Committees in the Federal Republic of Germany e.V.”, the Europe-wide General Data Protection Regulation, ISO 20916 (in-vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice) and ISO 20387 (Biotechnology — Biobanking — General requirements for biobanking) and are thus able to fully comply with the ethical principles required by IVDR 2017/746.

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