Bringing a digital health app to market is not a trivial task—especially when that app aims to be certified as a regulated medical device. For OAMN, a digital health innovator entering the medical sector for the first time, the challenge was clear: how to align their agile development with the stringent requirements of MDR (Medical Device Regulation), while structuring the certification process, and preparing for collaboration with specialized legal and regulatory stakeholders.

From day one, partnaer helped OAMN cut through the complexity with a structured and methodical setup that brought clarity, accountability, and coordination across the cross-functional team. Over several months, a strong foundation for certification was laid:

At the time of project completion, the application for certification was underway, with all necessary deliverables ready and validated. This positioned OAMN to proceed confidently with their legal partners toward regulatory approval.

The impact extended beyond regulatory checkboxes. The collaborative project not only accelerated OAMN’s route to certification but also introduced structured project management that will serve future launches.

Ready for Market. Ready for Scale.

Today, OAMN is well positioned to launch its medical app in the regulated health market—supported by a solid project foundation and clear regulatory pathway.