Neoventa - Medtech

A successfully completed MDR certification

Challenge

Neoventa Medical faced an urgent challenge: achieving MDR certification and taking ownership of one of their key products. Shifts in the competitive landscape led to a product shortage which made it crucial to ensure a steady supply. To address this, Neoventa Medical needed to focus on securing certification, scaling production, and strengthening sourcing reliability to guarantee continued availability.

Result

Goovinn supported Neoventa Medical through an extensive transformational journey, delivering analysis and a roadmap for several strategic development initiatives. Throughout this journey, Goovinn managed projects, of which ensuring the successful planning, development, and implementation of an updated QMS and technical documentation to secure MDR certification was critical. Additionally, the growing organization was trained and prepared to manage product and project development work efficiently. With the MDR certification successfully completed, Neoventa Medical is now fully compliant across the EU and other countries accepting CE-marked products. This achievement enables Neoventa to stay true to their commitment to maintaining close relationships and trust with over 1,000 European maternity units.