BioEcho Life Sciences, specialist supplier of right now’s quickest and most sustainable nucleic acid extraction know-how, receives two vital hallmarks for its high quality administration – DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016.
BioEcho Life Sciences has efficiently carried out a high quality administration system that conforms to the world-wide commonplace for medical gadget and in vitro diagnostic (IVD) manufacturing. From improvement and manufacturing to ultimate launch and distribution, prospects in medical diagnostics and molecular biosciences can depend on the security and effectiveness of all services and products.
The ISO 13485 High quality Administration Commonplace for Medical Units verifies that BioEcho Life Sciences complies with the necessities for a complete high quality administration system for the event and manufacturing of medical units, thus making certain product security and effectiveness. When it comes to the standard administration system necessities laid out in ISO 9001, the corporate might reveal its potential to persistently present merchandise that meet buyer and relevant statutory and regulatory necessities.
“The ISO 13485 and ISO 9001 certifications symbolize an vital milestone for our firm as they show our dedication to making sure high quality and offering the very best service to our purchasers. We offer future-oriented molecular biotech to contribute to sooner analysis of ailments and to introduce sustainability into fashionable molecular biology. The accreditations show we’ve got the processes and methods in place for this”,
Dr. Frank Schäfer, Managing Director and founder
Dr. Markus Müller, Managing Director and founder, underlines: “Our EchoLUTION nucleic acid extraction kits permit to scale back the consumption of laboratory and packaging plastics by 70 % in comparison with conventional Silica-based bind-wash-elute merchandise. The ISO 13485 and ISO 9001 certifications now give us the chance to develop into new markets just like the biopharmaceutical business and allow extra firms and establishments to scale back their environmental footprint.”
BioEcho. The Nucleic Acid Specialists.
BioEcho Life Sciences, positioned in Cologne, Germany, is a specialised resolution supplier for the extraction and evaluation of nucleic acids. We create disruptive applied sciences, merchandise, and workflows that make downstream processing of nucleic acids simpler and sooner, considerably enhance throughput, and ship dependable outcomes. Our EchoLUTION know-how allows the quickest DNA and RNA extraction available on the market – in only one single step. It reduces the related plastic consumption by as much as 70 %.
Clients in molecular diagnostics, educational and biopharmaceutical analysis, plant and animal breeding depend on our merchandise: ready-to-use kits, high-throughput options for automation platforms, nucleic acid extraction providers and course of optimization for molecular biology laboratories.
BioEcho’s Viral RNA/DNA Swab equipment was utilized in as much as 15 % of Covid PCR exams in Germany and 50 % of exams in Austria.
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