The manufacturer of high-tech laboratory equipment KNAUER Wissenschaftliche Geräte GmbH has passed the certification audit according to EN ISO 13485. With the introduction of this quality standard for medical devices, KNAUER raises its quality management to a new level and facilitates its access to more market segments.
The award-winning medium-sized company has been successfully working for years with a quality management system conforming to ISO 9001 and an environmental management system conforming to ISO 14001. According to KNAUER, the increased requirements of EN ISO 13485 for product quality as well as product and process safety will help to further increase the quality and reliability of its products - and the company also expects to achieve higher efficiency.
"It was a fair bit of work to expand our quality management system for medical device development and manufacturing, but we did it on the first try, and I'm really proud of our team. We are all delighted about the success,"
Kate Monks, Head of Quality & Regulatory at KNAUER
KNAUER, a company that has made a name for itself as a developer and manufacturer of systems and components for liquid chromatography, for decades has also been serving other companies in the laboratory equipment industry as an OEM supplier with its products under their own names. Recently, engineering developments according to customer requirements have increasingly been added in the field of life sciences and pharmaceutical production, a segment that will particularly benefit from the introduction of the new ISO standard.
Due to the similarity of many requirements of EN ISO 13485 with those for Good Manufacturing Practice (GMP), a guideline for the production of pharmaceuticals, KNAUER also expects synergies for customer projects in this environment.
KNAUER, based in Berlin-Zehlendorf, develops and manufactures laboratory equipment for the life science, pharmaceutical, biotechnology, chemical, environmental and food industries. The company is best known for liquid chromatography systems and components, but also played a crucial role in the production of lipid nanoparticles for mRNA corona vaccines with its newly developed equipment.
Company owner Alexandra Knauer manages the family business together with Carsten Losch. Both are committed to sustainable and responsible corporate governance with a focus on the users, the 190 employees and society.
More about KNAUER at www.knauer.net