RGAF 6230 - Regulatory Devices/Diagnostics

Institution:

Weber State University

Subject:

Description:

An in-depth exploration of the origins and application of regulations relevant to medical devices and diagnostics. Medical device and diagnostic product development is covered through an organizational strategy and regulatory compliance lens. The course analyzes the design and application of clinical trial data related to the medical device and diagnostic regulatory process. Post-marketing strategy and device labeling are also covered.

Credits:

2.00

Credit Hours:

Prerequisites:

RGAF 6000

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.weber.edu

Phone Number:

(801) 626-6000

Regional Accreditation:

Northwest Commission on Colleges and Universities

Calendar System:

Semester

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