Post-Market for Medical Technologies (Classroom & Asynchronous)
Training Provider: NATIONAL UNIVERSITY OF SINGAPORE
Course Reference: TGS-2024044124
S$1,620
Original: S$5,400
Save S$3,780
About This Course
This course aims to equip students with the knowledge of the post-market regulatory requirements of medical devices, and the activities involved in managing adverse events and conducting Field safety corrective action. Through this course they will learn about the construction and the benefit-risk assessment of a Corrective Action Preventive Action (CAPA), and its effectiveness in addressing safety concerns from the use of medical devices. Students should also expect a better understanding of the key regulatory considerations in product changes from safety issues, and articulate guidance documents related to post-market vigilance.
What You'll Learn
Post market vigilance is a key regulatory function in the total product life cycle. Continual monitoring and reporting of medical device adverse events are critical in ensuring the marketed devices are free from unacceptable risk. This 4-credit module introduces the key activities and roles essential for effective post-market vigilance, including adverse events, field safety correcting action and change management.
Entry Requirements
1. Bachelor's Degree.
2. Relevant experience in the field of health products regulatory affairs
Course Details
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