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Based on observations on our daily practices ISS AG developed sectoral trainings which are provided to customers directly or as part of courses at the Universities of Applied Sciences in Berne. Important topics include regulatory requirements about medical devices and the use of statistical tools within the MedTech (Medical Technology) industry.

Fundamentals of Regulatory Affairs and Patents

This lecture of the University of Berne presented as part of the Master Course Biomedical Engineering conveys the practice-oriented knowledge about regulatory requirements and the patent systems for medical devices. The product life cycle is treated regarding to legal framework conditions, approval procedures, standardization and patent law. Guest lecturers illustrate additional topics out of that often ignored but inevitable field of the medical technology industry.

Selected Topics to Regulatory Affairs

Within the Medical Technology Center at the University of Applied Sciences of Berne, ISS AG presents several subject specific lectures on Regulatory Affairs within the medical technology and medical information technology study programs. Various topics related to the clinical evaluation, market surveillance and documentation are presented in detail.