KYIVGUMA has extended its quality management system certificate according to the European standard EN ISO 13485: Medical devices. Quality management system.
The audit was conducted in April 2025, and we are pleased to announce that we have recently received certificates from the European authorised body TÜV AUSTRIA.
Certification includes:
- Design
- Manufacture
- Wholesale of medical devices in the following areas: rubber, silicone and polymers, first aid kits, wound dressings.
We already have a certified quality system according to the Ukrainian standard DSTU EN ISO 13485, but certification according to the European standard EN ISO 13485 is another proof that our quality approaches meet the highest international requirements. We continue to take steps towards the development and trust of our partners and consumers both in Ukraine and abroad.