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 […]
Sharing experience in bringing medical devices to the Ukrainian market
Two webinars on the conformity assessment of medical products in Ukraine took place on November 7th and 14th, 2023, gathering experts from around the world and addressing key regulatory issues concerning medical devices in Ukraine.
The first webinar, held on November 7th, focused on the fundamentals of compliance assessment and provided valuable information for importers, distributors, authorized representatives, and Ukrainian medical device manufacturers.
Viktoriia Moroz, a Key Account Manager, discussed crucial aspects such as medical product classification, conformity assessment procedures, the role of authorized representatives, necessary documentation, market surveillance, post-marketing, and the application of “non-medical” technical regulations.
The in-depth examination of conformity assessment stages and the provision of current information proved beneficial for both newcomers and leading professionals in the field of medical device regulation.
Access for registered participants was free, widening the circle of interested individuals and allowing for a detailed understanding of compliance assessment processes and national requirements.
During the second webinar on November 14th, Maksym Bagrieiev, managing partner, shared key information and expertise. Conducted in English, this webinar was a significant step in deepening the understanding of foreign partners regarding requirements and procedures in Ukraine.
Undoubtedly, both webinars gained popularity due to the quality material and the experience of the highly qualified team at “Cratia”.
Moreover, the webinars facilitated the creation of a forum for sharing experiences, as participants had the opportunity to ask questions to the speakers after both sessions. The “questions and answers” segment following the presentations turned out to be very active, even necessitating an extension of the webinar duration.
We extend our gratitude to all participants for their involvement, tireless engagement, and intriguing questions. We sincerely look forward to seeing you at our future webinars, seminars, or any opportunity to meet and exchange experiences.
If you have any questions for our speakers, please do not hesitate to reach out.
Questions can be sent to our email: info@cratia.ua. Our speakers will certainly respond to your inquiries and questions.
You can also call us at: +38 (068) 064-78-31, where you will receive consultation regarding medical devices.
With respect and care,
“Cratia” team.
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