A TU Delft MOOC on edX covering the European Medical Devices Regulation, relevant ISO standards and practical examples. Participants learn to classify devices, follow CE conformity procedures, assess risks, plan clinical research and introduce devices safely into hospitals. Accredited by the Dutch associations VZI and VDSMH.
What you’ll learn:
– Week 1: MDR introduction, definitions, device classes, CE conformity overview
– Week 2: conformity procedures and Annex I on example devices
– Week 3: risk analysis (ISO 14971, ISO/TR 24971)
– Week 4: clinical research and ethics
– Week 5: introducing and maintaining devices in the hospital
– Week 6: final assignment
Details:
Type: Course
Format: Online MOOC (edX), self-paced
Language: English
Start: Starts anytime
Price: Free; verified certificate paid
Provider: TU Delft – Learning for Life
Instructor(s): Arjo Loeve, John van den Dobbelsteen, Sonja Paus-Buzink
Contact: info@tudelft.nl
Fundamental and practical knowledge required for developing medical devices, from design to implementation, in compliance with the European Medical Devices Regulation.
Some affinity with medical devices or their design.
Engineers, researchers, clinical and hospital technology staff, users of medical devices
