Who we are
Good diagnostic products require high-quality human biomaterials (serums, standards, control samples, purified proteins, and antibodies). Out of this need, we founded ourselves in 1997 as a spin-off of the research department of B.R.A.H.M.S. AG. Understanding diagnostics and the resulting requirements for a good product is our basis. We recognized the need for the production of in vitro diagnostics and specialized in the secure, qualitative and ethical procurement of biological material. Since 2000, in.vent has been procuring project-oriented biological raw materials, especially for the diagnostic industry, as an independent body. Since 2018, we have been carrying out blood collection for our projects in our blood collection centre “Studienzentrum – Blut Hilft Forschen”. Quality, ethics, and partnerships are our cornerstones.
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.
