Client Success Story: RNDENT
At Obelis Group, we support medical device manufacturers not only with market entry but also with ongoing regulatory maintenance. RNDENT, an Israel-based manufacturer of Class I dental medical devices, partnered with Obelis Group to support an important regulatory update in the UK during the renewal of their MHRA account.
With the support of our consultant, Obelis ensured the process was handled accurately and efficiently.
Q: What regulatory support did you need from Obelis Group?
“During the renewal of our MHRA account, we needed to modify our device registrations to include additional models. While the process itself was straightforward, it required careful handling to ensure accuracy and compliance.”
Q: How did Obelis Group support you during this process?
“Obelis managed the registration modification smoothly and efficiently. We provided the Declaration of Conformity and CE Certificate, and André our consultant ensured everything was correctly submitted and updated within the MHRA system.”
Q: What was the outcome of the collaboration?
“The new device models were successfully added during the account renewal, and the process was completed quickly. The update allowed us to continue placing our products on the UK market without disruption.”
Q: What stood out most about working with Obelis Group?
“The efficiency and clarity of communication stood out. Our consultant’s structured approach made the process easy to follow, and the project was completed within a short timeframe.”
Reliable Support for Ongoing Compliance
With Obelis Group’s support, RNDENT successfully completed an important MHRA registration update while maintaining full compliance. We are pleased to support their regulatory activities in both the UK and EU markets.
At Obelis Group, we don’t just help you comply – we help you succeed.
Contact us at: marketing@obelis.net
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