Next-Generation Device Regulations(Synchronous e-learning)

About This Course

This module involves supervised self-study in the field of medical device regulatory science. The work will typically entails the assignment of medical devices developed using novel advanced technologies so that the student will spend the semester to explore the challenges of regulation of such devices and to develop innovative framework requirement for regulatory approval. During the course, the student will be presented with different confronted with scenarios including product design failure, clinical trials mishaps, IP issues, manufacturing non-compliance. These scenarios present to the student real-life case studies that challenges the student ability to solve/remedy the problems. Depending on the nature of the independent study, the student will develop appropriate skills in critical evaluation of various regulatory pathways, considering the various compounding factors like regulatory requirements from different countries, the clinical evaluation requirements, testings standards, reimbursement models, pre-market submission, post market survellience etc.