In recent months, several legislative acts have been adopted that significantly affect the regulation of medicinal products, specifically: A ban on advertising information on the labeling and information about persons other than the Manufacturer and MAH (marketing authorization holder), which comes into effect on January 18, 2025; Parallel import of medicines purchased by an authority […]
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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