BMT-62107 Regulatory Requirements for Design and Manufacture of Medical Devices, 5 cr
Juha Nousiainen, Minna Kellomäki
|Active participation in the lectures, accepted project work and final exam.|
The student is able to describe the regulatory pathway of a medical device from description of the intended purpose to placing into market and putting into service. Student is able to recognise the general safety and performance requirements for a medical device including the principles of risk management and clinical evaluation. Student can explain the main elements of a quality system covering design and manufacture, and choose a conformity assessment procedure based on classification rules. Student is able to understand the main principles and challenges of vigilance system and post-market surveillance.
|1.||Regulatory framework for medical devices in the European Union||Understanding the basic definitions and key concepts of the Regulations on medical devices and the requirements for economic operators|
|2.||General safety and performance requirements for medical devices||Understanding the use of harmonised standards and the requirements for a risk management system and clinical evaluation|
|3.||Quality management system for medical devices||Understanding of technical documentation and the requirements for a quality management system (with a reference to the standard EN ISO 13485:2016)|
|4.||Conformity assessment||Understanding the relation of the classification rules to the conformity assessment procedures and the role of conformity assessment bodies|
|5.||Post-market surveillance||Understanding the requirements for registration, traceability and vigilance system, and the role of Competent Authorities in market surveillance|
Ohjeita opiskelijalle osaamisen tasojen saavuttamiseksi
The final grade of the course is determined based on the assessment of all part of the course. The weighting factor of each part is given at the beginning of the course. Grades 1-2: Learning outcomes have been achieved with minimal insufficiency. Satisfactory command in core content of the course. Grades 3-4: The learning outcomes have been achieved. Very good command in core content and complementary knowledge of course content. Good or very good marks from all parts of the course. Grade 5: Some of the learning outcomes have been exceeded. Deep command in the core content and very good command in complementary content of the course. Almost maximum performance in all parts of the course.
Numerical evaluation scale (0-5)
|BMT-62107 Regulatory Requirements for Design and Manufacture of Medical Devices, 5 cr||BMT-62100 Regulatory Requirements for Design and Manufacture of Medical Devices, 3 cr|