CM100V Medical Technology Development under the Medical Device Regulation 4.0 credits

The course includes a review of the following contents:

• applicable directives, laws and regulations, including MDR
• liability issues
• applicable standards
• requirements for CE marking of medical devices
• requirements for clinical trials of medical devices
• the concept of quality
• requirements for a quality system
• risk management
• product and after-market monitoring

After completion, the participant will be able to:

• Apply the current medical technology regulations to medical technical product development
• Identify critical risks in the development of medical technology products
• sketch clinical trials including medical devices
• Identify needs for quality management systems applied to the development of medical technical products

Bachelor’s degree in engineering or biomedical science. English B 

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

• TEN1 - Written exam, 4.0 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.

Mats Nilsson

• 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.