Please note that significant changes in the regulation of medicinal products in Ukraine have taken place in recent months, including: The establishment of the National Price Catalogue and the introduction of mandatory price declaration, The imposition of limits on wholesale and retail mark-ups on medicinal products, Restrictions on advertising and marketing agreements, and the requirement […]
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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