Client Success Story: Harsoria Healthcare
For medical device manufacturers, entering a new market often means adapting an existing regulatory strategy to a different set of requirements. Harsoria Healthcare Pvt. Ltd., an India based medical device manufacturer, worked with Obelis Group to support the registration of its Class IIa devices in Switzerland.
The project was managed by Andre and included a Swiss Medical Device Review and registration of the company’s devices in swissdamed, Switzerland’s medical device database. The portfolio included products such as catheters, stopcocks, and tubing.
Q: What were you looking to achieve in Switzerland?
“We wanted to make sure our medical devices met the applicable Swiss regulatory requirements and complete the necessary registration process. Having already worked within other regulatory environments, we wanted a clear understanding of what was specifically required for the Swiss market.”
Q: How did Obelis Group support you throughout the project?
“Andre guided us through the Swiss regulatory requirements and reviewed the relevant documentation for our devices. He also supported us with the registration process in swissdamed and made sure the necessary steps were completed correctly.”
Q: How would you describe the process?
“The process was smooth and well organized. Communication was clear throughout, and we received the guidance we needed at each stage. The project progressed without any major difficulties.”
Q: What stood out about working with Obelis?
“We appreciated the regulatory knowledge and the straightforward approach. Andre was clear about what was needed and helped us move through the process efficiently.”
Supporting Medical Device Expansion into Switzerland
With the Swiss review and swissdamed registration completed, Harsoria Healthcare has taken another step in expanding the reach of its Class IIa medical device portfolio. Obelis continues to support manufacturers by helping them understand and navigate the regulatory requirements of individual European markets.
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