Certificates


We work with top-quality latex, use advanced technology, meet the highest standards and work with state-of-the-art equipment from top manufacturers.

The factory meets the requirements of the quality management system ISO 9001:2008 and ISO 13485:2003+АС:2009, and the production requirements according to the European Directive 93/42/EEC Annex II Article4.

 
The manufacturing cycle conforming to ISO 4074:2002 is implemented in the enterprise.

 
All the following are provided in the project design and have been successfully implemented in the factory:

 

  • Clean areas
  • Air preparation systems, including microbiological preparation for equipment ventilation and pneumatic systems
  • Laboratory furnished with state-of-the-art equipment meeting the ISO 4074:2002 standards
  • Archives with batches of released products