15 Credits AUTUMN

Aims/Description: Medical devices bring great benefit to patients, but it is essential to ensure that such devices are fit for purpose. This module explores the principles of regulation, and demonstrates how two of the world┐s largest regulatory frameworks (European and American) reduce risks and ultimately benefit the patient, the user and the manufacturer. You will simulate companies operating in this area, and learn the roles of Quality Standards, CE Marking, Notified Bodies, Competent Authorities and other key agencies. You will develop appreciation for the changing regulatory landscape, with special attention to the emerging use of computational modelling in this context.

Teaching Methods: Lectures, Seminars, Tutorials, Independent Study
Assessment: Course work, Project/ portfolio

Information on the department responsible for this unit (Mechanical Engineering):

Departmental Home Page
Teaching timetable


The content of our courses is reviewed annually to make sure it's up-to-date and relevant. Individual modules are occasionally updated or withdrawn. This is in response to discoveries through our world-leading research; funding changes; professional accreditation requirements; student or employer feedback; outcomes of reviews; and variations in staff or student numbers. In the event of any change we'll consult and inform students in good time and take reasonable steps to minimise disruption.

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Teaching methods and assessment displayed on this page are indicative for 2021-22. Students will be informed by the academic department of any changes made necessary by the ongoing pandemic.

Western Bank, Sheffield, S10 2TN, UK