OTS - R-Biopharm is IVDR certified
2022. June 30. 13:12
Darmstadt, 30 June, 2022 (OTS/APA) - The quality management system
of the biotechnology company complies with the European in-vitro
Diagnostic Regulation (IVDR)- Quality orientation is an integral
part of the culture and processes at R-Biopharm AG. The
biotechnology company from southern Hesse thus ensures that quality
is integrated throughout the entire company and continually
improved in order to deliver reliable products for the health of
patients in the long term. The family owned company has regular
audits conducted to check the suitability and functionality of all
quality-related elements. In fall 2021, R-Biopharm 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
biotechnology company in fall 2021. The IVDR certification will
ensure that R-Biopharm can continue to offer its clinical in vitro
diagnostics in Europe and worldwide according to the stricter legal
requirements. 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 makes R-Biopharm one of 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".
Picture is available at AP Images (http://www.apimages.com)
Press contact:
Simone Feiler
Head of Corporate Brand
Communication
https://r-biopharm.com
https://r-biopharm.com/contact/
https://r-biopharm.com/news-press/download-gallery/
R-Biopharm AG
An der neuen Bergstraße 17
64297 Darmstadt, Germany
Tel.: 0 61 51 - 81 02-538
Mobile: 0 160 - 55 273 60
Fax: 0 61 51 - 81 02-40
Email: s.feiler@r-biopharm.de
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