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Medical Device Regulatory Process Strategy and Planning (Synchronous e-learning)

Training Provider: NATIONAL UNIVERSITY OF SINGAPORE
Course Reference: TGS-2020507246
S$1,620
Original: S$5,400
Save S$3,780

About This Course

"In this module, the students take a prototype through a regulatory pathway in one of the regions such as US, EU, Asia Pacific, ASEAN and China based upon their understanding of the medical device regulatory process. Students will have both team and individual activities and deliverables for this module culminating in a simulated submission to be carried out by student teams.
The project module brings together the knowledge acquired from the earlier three modules i.e., BN5511, BN5512 and BN5513, to enables the students to apply the concepts learned. 1. To learn to strategize a Regulatory plan or proposal based on an existing clinical prototype medical device
2. To be familiar with the key elements of a good regulatory plan
3. Be conversant in individual and group presentation and report writing

"

What You'll Learn

In this module, the students take a prototype through a regulatory pathway in one of the regions such as US, EU, Asia Pacific, ASEAN and China based upon their understanding of the medical device regulatory process. Students will have both team and individual activities and deliverables for this module culminating in a simulated submission to be carried out by student teams. The project module brings together the knowledge acquired from the earlier three modules i.e., BN5511, BN5512 and BN5513, to enables the students to apply the concepts learned.

Course Details

Duration 39 hours
Language English
Training Commitment Full Time and Part Time
Total Enrolled 45 students
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