As Ukraine transitions to MDR and IVDR, the government aims to use European electronic systems rather than developing its own. This approach seems reasonable, but is it feasible? One of the key innovations of MDR and IVDR is the Unique Device Identification (UDI) system and the EUDAMED electronic database. In Ukraine, the regulation of medical […]
Cratia is ISO 13485 certified
Since 2017, Cratia has implemented and certified a quality management system under ISO 9001. To further enhance integration with medical device manufacturers’ systems, this year we have initiated the certification process according to the international quality standard ISO 13485, which is industry-specific for companies working with medical devices.
We are delighted to announce that our company has successfully completed the certification process to ISO 13485 requirements for the scope of Authorized Representative services for medical device manufacturers.
Our team is dedicated to providing high-quality services as a leading regulatory consultant, Authorized Representative, and reliable partner. With significant experience and expertise, we successfully assist with all regulatory matters, including implementing quality management systems in medical device manufacturing companies, developing technical documentation, and conducting certification procedures of any complexity.
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