Client Success Story: Bemems Co., Ltd.
For medical device manufacturers, maintaining regulatory documentation is an important part of navigating the requirements for the European market. For Bemems Co., Ltd., a medical device manufacturer from South Korea, this involved obtaining additional documentation for its Class IIb X-ray systems.
Having previously worked with Obelis on a legacy review, EUDAMED registration and a Certificate of Free Sale for Sri Lanka, Bemems returned to the team for further regulatory support. Afonso assisted the company with the issuance of a European Authorised Representative (EAR) Certificate for submission to its Notified Body. Following the review, the certificate was accepted, allowing Bemems to move forward with this stage of its regulatory process.
Continuing a regulatory journey with the right support.
Q: What led you to seek further support from Obelis?
“We had already worked with Obelis on the regulatory review and EUDAMED registration of our device, as well as documentation for another market. When we needed additional documentation for our Class IIb X-ray systems, continuing our collaboration with a team familiar with our regulatory background was a practical choice.”
Q: How did Afonso support you during this stage?
“Afonso assisted us with the issuance of the EAR Certificate for submission to our Notified Body. He supported us in preparing the documentation needed for the review and helped us progress through this stage of the process.”
Q: What was the outcome of the collaboration?
“The EAR Certificate was accepted by our Notified Body, which was an important step forward for our regulatory process. We appreciated having the necessary support to address this requirement and move ahead with greater clarity.”
Q: How would you describe your experience working with Obelis?
“Our experience has been positive. Having a regulatory partner familiar with our device and previous projects has been valuable, particularly as additional documentation needs arise throughout the regulatory process.”
Supporting manufacturers beyond the initial engagement
Bemems’ experience highlights the importance of ongoing regulatory support as medical device requirements evolve. By building on an established working relationship and providing assistance with additional documentation, Obelis continues to support the company’s regulatory activities for its Class IIb X-ray systems.
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