Safe Medical Devices

About this programme

Choose semester and course offering to see current information and more about the course, such as course syllabus, study period, and application information. Please note: all information from the Course syllabus is available on this page in an accessible format. Regulatory aspects: Legal prerequisites, safety, responsibilities, directives dealing with medical devices, standardization, clinical trials as a tool for demonstrating safety and efficacy, harmonization, certification and testing, product classes for devices and how to place a new product on the market. Quality: Quality as a working tool, total quality management (TQM), quality system. Safety and risk analysis. Development of quality system in industries/organizations, providing services/products for assurance that safe and efficient product reach the market. The main objective with this course is to give the student substantial understanding about the regulatory framework for medical devices and how personal protection and intended product performance can be assured by the medical device industry and the health care sector. 120 ECTS in natural sciences or technology. 6 ECTS in medicine or medical devices/medical technology. English B/6. 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. If the course is discontinued, students may request to be examined during the following two academic years.