Laboratory Instrument Manufacturer Knauer bags EN ISO 13485 Certification


Laboratory Instrument Manufacturer Knauer demonstrates its commitment to delivering Quality Medical Devices with ISO 13485 Certification.

KNAUER Wissenschaftliche Geräte GmbH completed the EN ISO 13485 certification audit successfully. It is a manufacturer of cutting-edge laboratory equipment. However, KNAUER elevates its quality management to a new level and makes it easier to enter more market segments by implementing medical device quality management standards.

The organisation maintained compliance with ISO 9001-compliant quality management system and ISO 14001-compliant environmental management system effectively for years. Moreover, to further improve the quality and reliability of its goods, KNAUER adopts the stricter EN ISO 13485 requirements for product quality and process safety to help the company operate more effectively.

“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,” said Kate Monks, Head of Quality & Regulatory at KNAUER.

KNAUER is a well-known company for developing and producing liquid chromatography systems and components for decades. Moreover, it also provides OEM laboratory equipment services to other businesses, selling its goods under their own brands. The life sciences and pharmaceutical production have recently seen an increase in technical advances based on client needs. Furthermore, this industry will notably profit from adopting the new ISO standard.

KNAUER anticipates synergies for customer projects in this setting because many of the standards of EN ISO 13485 are comparable to those for Good Manufacturing Practise (GMP), a standard for the manufacture of pharmaceuticals.

KNAUER, a Berlin-Zehlendorf-based company, creates and produces laboratory apparatus for the life science, pharmaceutical, biotechnology, chemical, environmental, and food industries. The company is best known for liquid chromatography systems and components used by recently created machinery to play a significant part in the manufacture of lipid nanoparticles for mRNA corona vaccines.

Carsten Losch and Alexandra Knauer are the company’s owners, who jointly run the family business. Both parties are dedicated to corporate governance that is sustainable and responsible and places a priority on users, the 190 employees, and society.

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