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 13485:2016, and the production requirements according to the European Directive 93/42/EEC Annex II Article 4.
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