Client Success Story: TTK Healthcare Limited – Heart Valve Division
TTK Healthcare Limited- Heart Valve Division, a leading Indian manufacturer of mechanical heart valves with over three decades of experience, has maintained a professional association with Obelis Group for more than 15 years. Recently, we partnered with Obelis Group to support the EUDAMED verification activities for our Class III medical device TTK Chitra Heart Valve and its related accessory set.
As the company aims expanding its presence in the European market, ensuring alignment with MDR requirements and EUDAMED obligations was a key priority. With the support of Obelis consultant Lilla, the verification process was completed smoothly and efficiently.
Q: What regulatory support did you need from Obelis Group?
“We required support for EUDAMED verification to ensure that our TTK Chitra Heart Valves and its accessories remained fully aligned with MDR requirements and the latest EUDAMED functionalities. As our products are intended for the EU market, maintaining compliance and ensuring accurate registration were extremely important for us.“
Q: How did Obelis Group support you during the process?
“Lilla provided structured and professional guidance throughout the verification process. The communication was clear, and the support helped us navigate the EUDAMED requirements efficiently. The collaboration was smooth, and all necessary steps were handled in a timely manner.”
Q: What was the outcome of the collaboration?
“The EUDAMED verification for TTK Chitra Heart Valve and its accessories were completed successfully, allowing us to maintain compliance and continue preparing for our long-term activities in the EU market. The process strengthened our regulatory alignment under the MDR framework.”
Q: What stood out most about working with Obelis Group?
“The expertise and professionalism stood out throughout the project. The support provided by Lilla ensured that the verification process remained straightforward and efficiently managed.”
Following this successful collaboration, we also look forward to continuing our partnership with Obelis Group for future MDR review activities as we further strengthen our regulatory strategy in Europe
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