Client Success Story: KORAVIE’s – UK
At Obelis Group, we help med-tech innovators navigate regulatory complexity with clarity and confidence. KORAVIE LIMITED, a UK-based start-up developing a Class I skin-barrier device, began their journey with limited in-house regulatory experience. Determined to bring their product to the UK and EU markets, they partnered with us to turn uncertainty into action.
Q: What challenges did you face before working with Obelis Group?
“We were stepping into unfamiliar territory. Although our Korean manufacturer had much of the technical documentation, we weren’t sure what was required—or how to align everything with UK and EU medical device regulations. We needed support with classification, documentation structure, and the specific steps for registration.”
Q: How did Obelis Group help you overcome these challenges?
“From day one, Obelis offered in-depth, practical consultancy. Our expert consultant, Homer, helped us structure a compliant technical file and guided us through labelling, packaging, and Instructions for Use—ensuring everything from intended use to warnings was properly addressed. He translated complex requirements into clear, tailored guidance.”
Q: What results did you achieve through this collaboration?
“With Obelis’ support, our device was successfully registered on the MHRA portal. We’re now ready to place our product on the UK market with full confidence. Without their guidance, the process would have been far more stressful and prone to delays.”
Q: What stood out most in your experience with Obelis?
“Their step-by-step support, responsiveness, and deep knowledge of regulatory requirements made a big difference. We didn’t just check boxes—we understood the “why” behind each step. That clarity gave us the foundation to move forward, and now we’re confidently preparing for our EU market entry.“
From Uncertainty to Market Readiness
KORAVIE LIMITED transformed a challenging starting point into a readiness to successfully launch into the UK market. With the right guidance and regulatory insight, they built a strong foundation for future growth. We’re proud to be part of their journey—and excited to support their next steps into the EU.
At Obelis Group, we don’t just help you comply—we help you succeed.
Contact us at: marketing@obelis.net
The information contained on obelis.net is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.