Home > Courses > Post-market vigilance: Regulatory activities for monitoring In Vitro Diagnostic Devices (IVD) and Software as Medical Devices (SaMD)

Post-market vigilance: Regulatory activities for monitoring In Vitro Diagnostic Devices (IVD) and Software as Medical Devices (SaMD)

Training Provider: NATIONAL UNIVERSITY OF SINGAPORE
Course Reference: TGS-2022016685
S$570
Original: S$1,900
Save S$1,330

About This Course

This course aims to provide an overview of the post-market processes for monitoring the safe and effective performance of medical devices, including healthcare softwares and applications, as well as complying with requirements for changes and updates to the products after regulatory approvals. Key recommendations from the International Medical Device Regulators Forum (IMDRF) will form the foundational understanding, in addition to requirements from major reference regulators and the regional ASEAN directive. With an insight into the interactions among key regulatory organisations, participants will equip themselves with knowledge of the good practices in post-market surveillance.

What You'll Learn

As new medical devices and technologies enter into the healthcare system at an exceedingly fast speed, it is important that the safety and effective performance of these innovations comply with required standards throughout their product life cycle. This course aims to provide a better understanding of the activities and requirements expected of these health products after regulatory market approval, that contributes to safeguard the public health as we reap the benefits in enhancing patient care.

Entry Requirements

1. Bachelor's Degree
2. Relevant experience in the field of medical device regulatory affairs

Course Details

Duration 14 hours
Language English
Training Commitment Not specified
Total Enrolled 17 students
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Note: To apply for this course, visit or contact the training provider directly.

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