DTEK2096 Medical device regulation and quality management systems, 3 ECTS wb_sunnySustainable development
DTEK2096 Medical device regulation and quality management systems, 3 ECTS
Learning outcomes
The objectives of this course are:
- to learn about the regulatory framework and the regulatory requirements for medical devices,
- to know the basics of quality management systems and the ISO13485 standard,
- to learn the requirements for the technical documentation of a medical device,
- to understand the roles of different actors in the medical device sector,
- to understand risk management of a medical device using the ISO14971 standard.
Content
In this course, we learn about the different legislations that affect the development and manufacturing of medical devices. We look at what kind of processes are needed to ensure the safety of medical devices. We develop a basic model of a quality manual for medical device manufacturer and generate technical documentation for a medical device using publicly available information.
Study methods
Lectures, exercises, group work, and written exam.
Course unit methods
Lectures (18h), studying the course materials (27h), exercise sessions (9h), exercise group work and meetings (27h), exam.
Learning material
ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes EU Medical Device Regulation 2017/745 (MDR) EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR)
Assessment scale
0-5
Languages
Finnish
Level
Intermediate Studies
Subject
Biomedical Engineering and Health Technology
Person in charge
Tuomas Valtonen, Lasse Suvanto
Classification
Sustainable development
