Objectives
After completing this module students should be able to:1. Understand and analyse the medical device development process from design to post market obligations2. Comprehend the various risk-based classification strategies adopted in various countries3. Identify and understand the various 'Ethical' contexts as relevant to medical devices4. Critique and discuss various case studies, including on safety, quality management and post market obligations for medical devices5. Demonstrate and evaluate the qualities needed to be a good medical device regulatory professional
Who Should Attend
This module is suitable for any science/engineering student interested to know more about how medical devices are classified and regulated across different countries in the world, as well as how to ensure quality/compliance/safety of such devices and other relevant issues including ethical issues.
Entry Requirements
Graduate level Physics or BN5401 or consent of instructor
Class Schedule
Friday (6.00 PM - 9.00 PM)
Lesson Delivery
a) Lecture - 2 hours
b) Tutorial - 1 hours
c) Project - 2 hours
d) Preparation - 5 hours
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Please note that the mode of delivery is subject to change in light of the COVID-19 situation.
Courses marked ‘online’ may have compulsory face-to-face sessions such as laboratory or hands-on components and details should be sought from the schools or departments before learners register for them.
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Last updated: 16 April 2024
