Medical Device Regulation GC

Describe and discuss the role of medical devices and combination products in diagnosing, mitigating, managing, and curing medical disease and conditions, including their modes of action, and adverse effects.

Describe the life cycle of a medical product as well as as the roles and responsibilities of clinical research, regulatory affairs and quality professionals throughout the life cycle.

Classify medical devices and identify their regulatory path to market in the US, EU, and other geographies.

Classify medical devices and identify their regulatory path to market in the US, EU, and other geographies.

Identify and apply the codes of ethics that apply to medical device professionals, and in particular those related to conducting clinical research on human subjects.

Identify and apply the codes of ethics that apply to medical device professionals, and in particular those related to conducting clinical research on human subjects.

Apply the principles of Good Documentation Practices.

Demonstrate use of appropriate terminology and acronyms used in the clinical research of medical devices.

Demonstrate use of appropriate terminology and acronyms used in the clinical research of medical devices.