Regulatory requirements for design and manufacture of medical devices

Regulations on health technology products in Europe have changed significantly in recent years and many practices are still evolving. Up-to-date information on regulations and requirements are the keys to successful product development and manufacture of health technology products.

This course focuses on the EU Regulation on Medical Devices (MDR) and the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR). In this course you will get up-to-date information e.g., general safety and performance requirements, classification, technical documentation, risk management system, clinical and performance evaluations, post market surveillance system, quality management system, conformity assessment and the role of conformity assessment bodies.

Target group

This course is targeted for those who are working or willing to work in health technology companies in different roles in R&D, quality and regulation, production, marketing and sales and management. The course gives essential knowledge also for health technology start-ups and anyone who wants to update his or her knowledge about MDR and IVDR.

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).