Important certification for Abionic

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22.03.2012

Abionic announced today that it has been certified ISO 9001/13485 including research, development and commercialization of in vitro diagnostic devices for allergies detection. The certification is a prerequisite for business activities in the Medtech market. It proves that the young company from Lausanne is committed to provide physicians with safe and high quality in vitro diagnostic products.

Abionic has received the ISO 9001 and ISO 13485 certification. The standard ISO 13485 specifies requirements for a quality management system where an organization has to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. The certificates were issued by Société Générale de Surveillance (SGS). SGS is the world's leading inspection, verification, testing and certification company.

"We are very proud of this achievement as it is an important milestone in the development of the company. Receiving the ISO 9001/13485 certification proves that Abionic is committed to provide physicians with safe and high quality in vitro diagnostic products, starting right from the product design to the commercialization stage.” said Nicolas Durand, CEO of Abionic.

Abionic was incorporated as Swiss SA (Société Anonyme) in September 2010 and has its headquarters based in Lausanne, canton of Vaud, Switzerland. The company is positioned at the boundaries of medical technology, biotechnology and nanotechnology. As a spin-off from EPFL (Swiss Federal Institute of Technology Lausanne, Switzerland), Abionic uses the most advanced technology to supply physicians with a novel diagnostic tool and thereby providing patients with personal allergy profiles. Abionic aims to become an important international player in the field of personalized allergy detection. The company won the Award of the W. A. de Vigier Foundation in 2011.

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