The course contains 10 Lessons taking about
50 Minutes
Incidents in which a device may have caused or contributed to a death or serious injury must to be reported to FDA under the Medical Device Reporting program. This course will review the requirements of the Medical Device Reporting (MDR) regulation for hospitals.
Lessons:
1 : Overview
2 : History of the Safe Medical Devices Act
3 : Classes of Devices
4 : User Facilities
5 : Reporting Injuries
6 : Individual Report Elements
7 : Semiannual Report Elements
8 : MedWatch
9 : Recordkeeping
10 : Enforcement
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