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

Purpose and goal:

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 results and 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.