ETI 1030 - Regulatory Environment For Medical Devices

Institution:

St. Petersburg College

Subject:

Description:

3 credits This course will provide an understanding of the basics of the Food and Drug Administration (FDA) regulation and compliance for medical devices including how the various activities within a medical device company are affected by the FDA regulations. Additional coverage will include the applicable laws and regulatins enforced by the FDA; international standards and regulations; the regulations controlling medical device design and development; the medical device approval process; laboratory and clinical studies; the introduction to the Quality System Regulations (QSRs); and the FDA inspection process. 47 contact hours.

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.spcollege.edu

Phone Number:

(727) 341-4772

Regional Accreditation:

Southern Association of Colleges and Schools

Calendar System:

Semester

The Course Profile information is provided and updated by third parties including the respective institutions. While the institutions are able to update their information at any time, the information is not independently validated, and no party associated with this website can accept responsibility for its accuracy.