Cratia Medtekhnika has obtained ISO 13485

Cratia Medtekhnika, as an Authorized Representative for foreign medical device manufacturers, has been certified and continuously maintains ISO 9001 quality management system certification since 2017.

We are pleased to announce that our company has recently completed the certification process in accordance with the requirements of ISO 13485 for Authorized Representative services for medical device manufacturers.

Our team is dedicated to ensuring high quality as a leading regulatory consultant and a reliable partner. With extensive experience, we are able to successfully assist with all regulatory matters, including the implementation of quality management systems in medical device manufacturing companies, technical documentation development, and conducting certification procedures of any complexity.


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Baggovutivska str. 17-21, 6th floor, 04107, Kyiv, Ukraine
work days at 9-30 to 18-00 by Kyiv time (GMT +02:00)