Certifications

 

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To ensure the highest quality of our products, we have implemented and support a Quality Management System in accordance with EN ISO 9001:2008 and EN ISO 13485:2012+AC:2012, certified by TUV Rheinland LGA Products GmbH. The certifications cover designing and development, manufacturing, distribution and servicing of active medical endoscopy devices and fluid pump tubing sets. Additionally, to meet all legal requirements as a manufacturer of medical devices, we have obtained EC Certificate according to Directive 93/42/EEC Annex II, excluding section 4.


By manufacturing reliable and solid equipment we do our best to meet expectations of the most demanding customers that is reflected in the increasing number of devices sold world-wide. According to our quality targets we constantly focus on development of new endoscopy solutions which are meant to be successfully used in hospitals around the globe.

 

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