Medixion

MDR Consultancy specializes in guiding the development and compliance of medical devices in line with EU MDR 2017/745. With a background in Biomedical Engineering (Medical Devices), Medicine, and Aerospace Technology & Management, we offer consultancy services focused on safety management, design validation, and ensuring that medical devices meet regulatory standards. Our expertise includes: Design input & intended purpose Device classification Risk assessment & FMEA Design validation: wet & lab tests Design verification Usability testing IMDD & Technical documentation Clinical trials For more information, please visit our website: medixion.net mike.dehaan@hotmail.com