Discover how Obelis supported Harsoria Healthcare in expanding its Class IIa medical device portfolio into Switzerland. From reviewing the applicable Swiss regulatory requirements to supporting registration in swissdamed, Obelis helped ensure a smooth and well-organized market entry process.
Discover how Medorah Meditek prepared three Class I medical devices for the European market with Obelis’ support on MDR compliance, technical documentation review, and EUDAMED verification, helping the company move forward with greater confidence.
Discover how Obelis Group supported REVE LTD. throughout its UK cosmetics compliance journey, from PIF review and CPSR preparation to SCPN notification, helping the company bring its lipstick to market smoothly, efficiently, and with confidence.
Discover how Obelis Group supported Sanava AB throughout the complete EU cosmetics compliance process, including laboratory testing, CPSR preparation, PIF review and CPNP notification, helping the company confidently bring its night face cream to the European market.
Obelis Group supported Azista Industries Private Limited with an MDR review and EUDAMED verification, helping ensure continued compliance with EU regulatory requirements. Through expert guidance and practical recommendations, the project strengthened the company’s regulatory framework and supported its ongoing access to the European market.
KNBEAUTY Co., Ltd. partnered with Obelis Group to successfully update its UK GPSR documentation for a range of artificial eyelashes. Obelis ensured the company’s product documentation remained fully aligned with UK requirements, enabling uninterrupted market access with confidence.
With Obelis Group’s support, TTK Healthcare Limited successfully completed EUDAMED verification for its Class III heart valve devices, strengthening MDR compliance and supporting its continued growth in the European market.
ODACITÉ partnered with Obelis Group to achieve EU and UK compliance for its Nourishing Lip Serum SPF 40. With support for safety assessment, product notifications, and regulatory guidance, the brand successfully brought its product to market with confidence.
JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD. successfully completed large-scale EUDAMED verification for more than 1,100 medical devices with the support of Obelis Group, ensuring efficient EU compliance and smooth registration of Class Ir and Class Is devices.
Biobeat Technologies Ltd. successfully completed its EUDAMED verification and mandate update with the support of Obelis Group, ensuring uninterrupted access to the EU market through clear regulatory guidance and expert support.