Client Success Story: Athenese-Dx Pvt. Ltd.
Athenese-Dx Pvt. Ltd., an India-based company, partnered with Obelis Group to navigate the EU IVDR regulatory pathway for their biochemistry analyser. With the guidance of Obelis consultant Lilla Jászberényi, they turned a complex and challenging process into a clear, structured journey toward full compliance.
Q: What regulatory support did you need from Obelis Group?
Athenese-Dx Pvt. Ltd.:v
“We needed expert guidance for the EU IVDR process, including EUDAMED registration and a full review of our technical documentation. The process was complex, and we wanted to ensure that every requirement was fully met to allow our product to enter the EU market confidently.”
Q: How did Obelis Group support you during the process?
“Lilla provided precise, step-by-step guidance and was always available to answer our questions. We were in close contact, sometimes two or three times a day, especially while completing the EUDAMED registration file. Whenever adjustments were needed, her recommendations were clear and easy to implement, making the process smooth and efficient.”
Q: What was the outcome of the collaboration?
“Thanks to Lilla’s expert support, the EU IVDR review and EUDAMED registration were completed successfully, and our biochemistry analyser is now fully compliant and placed on the EU market. The process was seamless, and we had full confidence at every step.”
Q: What stood out most about working with Obelis Group?
“The combination of expertise, responsiveness, and clear communication made the collaboration exceptional. Lilla’s hands-on approach and strategic guidance transformed a complex regulatory challenge into a smooth and successful market entry.”
With Obelis Group’s support, Athenese-Dx Pvt. Ltd. achieved full EU market access, combining regulatory confidence with a strong foundation for future growth.
At Obelis Group, we don’t just help you comply – we help you succeed.
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