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5:45 pm |
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Subject: Engr Tech Leadrshp (Grad) (ETLS)
CRN: 41503
Lecture
St Paul: O'Shaughnessy Science Hall LL18
Charmaine Dwyer, Candice Burns
This course teaches the student about submissions for regulatory approval of medical devices. Topics include: medical device law, custom and research devices, significant and non-significant risk devices, FDA investigational device exemption, 510(k) substantial equivalence determination, pre-market approval, PMA supplements, third party review, combination devices, European economic area CE mark, international harmonization, MDR, device tracking, post market surveillance, and annual post approval reporting. Depending upon the degree of class interest medical device submissions in Canada, Australia and Japan may be covered.
3 Credits