Health techlology regulations and standards words
Continuing Education

Regulatory requirements for design and manufacture of medical devices

Health techlology regulations and standards words
The course provides in-depth information on the requirements and regulations for 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.

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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).

Here are all the courses and the study module mentioned previously