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.
MDR compliance
From Regulatory Uncertainty to a Successful UK Product Launch
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.
One Product, One Goal, Complete EU Compliance
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.
Supporting a Smooth Path to MDR Compliance in Europe
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.
EUDAMED becomes mandatory on 28 May 2026: deadlines for actor, device, and certificate registrations
EUDAMED becomes mandatory on 28 May 2026. Discover key deadlines for actor, device, and certificate registrations under MDR and IVDR, and how to prepare.