METS 1035 - Medical Device Quality Systems

Institution:

Hennepin Technical College

Subject:

Description:

This course introduces the student to aspects of medical device manufacturing quality systems that fall under federal and international regulation. The student will gain knowledge of US regulations including: Quality Systems Requirements (QSR), current Good Manufacturing Practice (cGMP), and Quality Systems Inspection Techniques (QSIT). International regulations such as ISO 13485 will also be covered. Emphasis will be placed on understanding how domestic and international regulations affect design, development, documentation, production, corrective and preventive action, and site inspection in manufacturing facilities. Students will practice proper documentation techniques and participate in mock audits. (Prereq: None) (BP) 3 cr

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.hennepintech.edu

Phone Number:

(952) 995-1300

Regional Accreditation:

North Central 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.