On the road to CE-mark. Design of clinical investigation for Wunderhaler - medical device for correct inhalation.

Important results from the project

The goal for the project was to design initial phases of clinical investigation needed for CE-mark. We have fulfilled the plan and designed steps for clinical investigation.

Expected long term effects

We gained deep understanding of the regulatory process for medical device approval, designed the needed documents and learned best practice from top-notch professionals.

Approach and implementation

We used workshops where our team discussed with the experts all possibilities and strategies. We received professional templates, which we filled with information under the guidance of the experts.