Client Success Story: JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD.
JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD., a China-based medical device manufacturer, partnered with Obelis Group to support a large-scale EUDAMED verification project involving more than 1,100 devices. In parallel, Obelis also supported the registration of several Class Ir and Class Is devices for the EU market.
With the support of Obelis consultant Davide, the project was managed efficiently despite the complexity and scale of the regulatory requirements.
Q: What regulatory support did you need from Obelis Group?
“We required support for EUDAMED verification for a large number of devices, as well as registration activities for several Class Ir and Class Is products. Due to the complexity of the process, it was important for us to work with an experienced regulatory partner who could guide us accurately through each step.”
Q: How did Obelis Group support you during the process?
“Davide carefully reviewed our EUDAMED data and identified fields that required correction before verification could proceed. He also helped resolve a technical issue within EUDAMED that prevented the Notified Body from linking the CE Certificate to our company profile. His proactive support and detailed guidance enabled us to address these issues efficiently and continue the process without unnecessary delays.”
Q: What was the outcome of the collaboration?
“The EUDAMED verification process and the registration of our Class Ir and Class Is devices were completed successfully. Thanks to the close collaboration and efficient communication, the project progressed smoothly despite its complexity and scale.”
Q: What stood out most about working with Obelis Group?
“The professionalism, responsiveness, and problem-solving approach stood out throughout the collaboration. Davide provided clear guidance at every stage, and communication remained efficient and constructive. We also appreciated the collaborative approach, which made the overall process easier to manage.“
With the support of Obelis Group, JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD. continues to strengthen its regulatory position in the EU market with confidence and reliable compliance support.
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