Regulatory requirements for design and manufacture of medical devices
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The main emphasis is on the EU Medical Devices Regulation (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR). General safety and performance requirements, classification, technical documentation, risk management system, clinical evaluation and performance evaluation, post market surveillance system and vigilance, quality management system, conformity assessment and the role of conformity assessment bodies will become familiar with this course.
This study module is targeted for those who are working or willing to work in R&D and/or quality and regulatory roles in health technology companies. The module gives essential knowledge about product development and regulatory affairs also for health technology start-ups.
This course is part of Health technology solutions – product development and commercialization (programme). Get acquainted with the programme and other courses included in it.
The programme offers a formal additional education for a “Person responsible for regulatory compliance” required by the new EU regulations in Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR).