Nucleic acid experts receive double certification
Certification demonstrates that BioEcho Life Sciences quality management system conforms to the standard for medical device and in vitro diagnostic manufacturing
11 Mar 2022
BioEcho Life Sciences, a specialist provider of fast and sustainable nucleic acid extraction technology, has received two important hallmarks for its quality management – DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016.
BioEcho Life Sciences has successfully implemented a quality management system that conforms to the worldwide standard for medical device and in vitro diagnostic (IVD) manufacturing. From development and manufacturing to final release and distribution, customers in clinical diagnostics and molecular biosciences can rely on the safety and effectiveness of all products and services.
The ISO 13485 Quality Management Standard for Medical Devices verifies that BioEcho Life Sciences complies with the requirements for a comprehensive quality management system for the development and manufacturing of medical devices, thus ensuring product safety and effectiveness. In terms of the quality management system requirements specified in ISO 9001, the company could demonstrate its ability to consistently provide products that meet customer and applicable statutory and regulatory requirements.
"The ISO 13485 and ISO 9001 certifications represent an important milestone for our company as they prove our commitment to ensuring quality and providing the best possible service to our clients. We provide future-oriented molecular biotech to contribute to the faster diagnosis of diseases and to introduce sustainability into modern molecular biology. The accreditations prove we have the processes and systems in place for this", says Dr. Frank Schäfer, Managing Director and founder.
Dr. Markus Müller, Managing Director and founder, underlines: "Our EchoLUTION nucleic acid extraction kits allow to reduce the consumption of laboratory and packaging plastics by 70 % compared to traditional Silica-based bind-wash-elute products. The ISO 13485 and ISO 9001 certifications now allow us to expand into new markets like the biopharmaceutical industry and enable more companies and institutions to reduce their environmental footprint."