Quality orientation is an integral part of the culture and processes at R-Biopharm. The company thus ensures that quality is integrated into all processes and continually improved in order to deliver reliable products for the health of patients in the long term. R-Biopharm has regular audits conducted to check the suitability and functionality of all quality-related elements. In fall 2021, it was one of the first companies to undergo the comprehensive audit for the new IVDR certification by TÜV SÜD and has now received the certificate.
What has become mandatory for manufacturers of in vitro diagnostics throughout Europe after a five-year transitional phase at the end of May 2022 in accordance with the European regulation for in vitro diagnostics has already been proven by the company in fall 2021. The IVDR certification will ensure that it can continue to offer its clinical in vitro diagnostics in Europe and worldwide according to the stricter legal requirements. After the simultaneous recertification according to MDSAP (Medical Device Single Audit Program), ISO 9001:2015, and DIN EN ISO 13485:2016 as well as the Directive for in-vitro diagnostics 98/79/EC R-Biopharm is amongst only few companies worldwide that are currently certified according to these four standards.
With its holistic quality management system, R-Biopharm ensures that normative and regulatory requirements are fulfilled from the development to the application of products and that correspondingly high-quality standards apply. “In our company, quality is not the action of a few but rather the attitude of all our employees”, says board member Dr Hans Frickel. “Our focus on quality is also highly relevant internally. By applying quality-oriented standards, we can detect risks and errors, efficiently design working methods, identify our strengths and potentials, and derive needs for action that will help us to continually improve”.
