Case Study: MVision AI Oy streamlines EU MDR, ISO 13485 and MDSAP certification with BSI

MVision AI Oy streamlines 3 certifications with BSI for faster EU MDR market entry

MVision AI Oy, a Finnish innovator of AI-powered medical software, faced a significant challenge in achieving timely EU MDR certification for its radiotherapy device during the regulatory transition. The company was dealing with multiple audits from separate Notified Bodies for EU MDR, ISO 13485, and MDSAP, which increased complexity, risk, and the potential for costly delays that threatened its product launch and global expansion plans.

BSI implemented a solution by becoming the single Notified Body for all certifications, providing a dedicated Scheme Manager as a central point of contact. This allowed for parallel audits and structured guidance, which streamlined the entire process. As a result, BSI enabled MVision AI Oy to reduce complexity, maintain momentum, and achieve a more predictable and efficient route to market, successfully supporting its global expansion goals.

MVision AI Oy