Health techlology regulations and standards words
Continuing Education

Regulatory requirements for design and manufacture of medical devices

Extent

5 ECTS

Course dates

-

Fees

1400.00 € + VAT 24 % (Price incl. VAT 1 736 €)

Faculty or School

Faculty of Medicine and Health Technology

Language of instruction

English

Study fields

Management, Administration and Economics
Technology and Natural Sciences
Health and Welfare
Data Processing and Information Technology

Organising unit

Tree – Continuing Education

Mode of study

Multi-modal teaching
Online studies

Study level

Other studies
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.

Target group

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).

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Here are all the courses and the programme mentioned previously