CM204V Quality Managment Systems and Regulatory Framework in Clinical Engineering 5.0 credits

The course includes a review of the following contents:

• applicable European directives, national laws, regulations and directions including MDR
• liability issues
• applicable standards
• the concept of quality
• quality management system for medical technology operations
• patient safety when using medical devices
• handling accidents and incidents
• adverse event analysis
• risk management in the use and handling of medical devices

After completion, the participant will be able to:

• analyse the current regulatory framework for medical technology operations in detail
• identify the necessary parts in a quality management system
• give details for developing a quality management system for medical technology operations
• identify critical risks in medical technology operations

120 credits in technical, natural or medical sciences or in human resource studies. Alternatively, 2 years of professional experience in health/medical care.

If the course is discontinued, students may request to be examined during the following two academic years.

• TEN1 - Written exam, 5.0 credits, grading scale: P, F

Based on recommendation from KTH’s coordinator for disabilities, the examiner will decide how to adapt an examination for students with documented disability.

The examiner may apply another examination format when re-examining individual students.

Mikael Forsman

• All members of a group are responsible for the group's work.
• In any assessment, every student shall honestly disclose any help received and sources used.
• In an oral assessment, every student shall be able to present and answer questions about the entire assignment and solution.