Speeding time-to-market with our platform model

Traditionally, CE certification for medical devices can take up to 18 months, requiring exhaustive reviews by Notified Bodies like TÜV Süd. With our platform strategy, we have completely transformed this process.

Both ServoPen and YpsoPen are certified under the Medical Device Regulation (MDR), allowing us to perform the conformity assessment without involvement of the Notified Body for every new product variant immediately after development.

For our customers, this means quicker access to market, translating into immediate revenue streams and a significant competitive edge.

Ypsomed: your trusted partner and all-in-one solution for MDR compliance

Navigating MDR compliance can be complex, but Ypsomed simplifies the process for our pharmaceutical partners with an all-in-one solution. As the legal manufacturer for our CE-certified reusable pens, we take full responsibility for compliance certification, technical documentation, labelling, and instructions for use (IFU). By managing regulatory responsibilities centrally, we ensure market readiness, implement updates as needed, and reduce administrative complexity.

This comprehensive approach provides long-term reliability and frees our partners to focus on their core expertise—developing and delivering life-changing medications.