Regulatory requirements for design and manufacture of medical devices
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.
Join this course to deepen your skills!
This course is part of Health technology solutions – product development and commerzialization study module. Get acquainted with the study module and other courses included in it. The study module 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).