As a main objective, BIOSINTEX aims to provide products and services competitive in terms of quality and safety.
BIOSINTEX successfully belongs to the family of European producers and distributors of medical devices, by complying with the following applicable standards and legal norms:
• Annex II of Directive 93/42/EEC on medical devices with subsequent modification, transposed into HG No. 54/2009, regarding the rules of placing medical devices on the market
• ISO 9001:2008 (SR EN ISO 9001:2008) Quality management systems – Requirements
• ISO 13485:2003 (SR EN ISO 13485:2012) Medical devices – Quality management systems – Requirements for regulatory purposes