Pre-Market Requirements and Post Market Surveillance(Sync e-learning)
About This Course
"Premarket approval is conducted by appropriate regulatory authorities and Conformity Assessment Bodies bodies to evaluate the safety and effectiveness of medical devices prior to marketing. The process may vary from jurisdiction to jurisdiction. The students will learn about the essential principles of safety & performance of medical devices including various design and manufacturing parameters and requirements. This module will outline the various strategies and components of such post-market surveillance systems including vigilance reporting, handling of customer complaints and product recalls. 1. To gain an understanding of the pre-market approval process and post market obligations
2. To be conversant with the essential principles of safety and performance of medical devices.
3. To gain an understanding of the requirements of postmarket vigilance including reporting, and complaints handling and recalls.
Understanding conformity assessment of medical devices and how it is related to quality management system.
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What You'll Learn
surveillance systems including vigilance reporting, handling of customer complaints and product recalls."
Entry Requirements
The Graduate Certificate will be open to those with a relevant bachelor’s degree or its equivalent. Candidates with relevant qualifications and related working experience may also apply for the program. Each application will be reviewed by a Board of Admissions.