Clinical Evaluation – Single-Use Overtube
CHALLENGE: In March 2022, our client sought EU MDR 2017/745 compliance and CE-marking for their single use overtube. The product was intended to be used with an endoscope for intubation, changing endoscopes, and/or treatment in the gastrointestinal tract in adults. Clinical evaluation planning and reporting was an area where support was needed. Navigating the EU […]
