Quality Assurance Management Certificate for Medical Devices

Program #24128

Students who complete the Certificate will be prepared to obtain an entry-level position in quality assurance within the medical device industry. Topics covered include regulatory agencies and laws pertaining to the medical device industry; introduction to the medical device industry and trends in the field; document control and database management; quality assurance concepts for medical device manufacturing; technical writing; the quality audit process; and employability skills. Upon successful program completion, students will have the skills required of positions in the medical device industry such as quality assurance specialist, quality compliance specialist and quality systems auditor. This certificate will also benefit incumbent workers seeking promotional opportunities within the industry.

Core Courses
BMGR 645 Introduction to Medical Device Quality Assurance36
BMGR 648 Regulatory Affairs for Medical Devices36
BMGR 651 Document and Database Management for Medical Devices36
BMGR 654 Quality Assurance for Medical Devices36
BMGR 657 Technical Writing for Bio-Medical Industries36
BMGR 660 Quality Auditing for Medical Devices36
Total Hours216

BMGR 645 36 Hours Introduction to Medical Device Quality Assurance

This course introduces students to the medical device industry in preparation for an entry-level position as a Quality Assurance Specialist. Learn about the industry's size and scope, current trends, and the wide range of products used in a variety of healthcare settings. Industry job resources are also covered. (Apportionment)

BMGR 648 36 Hours Regulatory Affairs for Medical Devices

Course will provide students with an in-depth understanding the regulations and regulatory agencies that are specific to the medical devices industry. The course will cover U.S. and European Union (EU) regulations and related agencies. Includes laws governing the development, manufacturing and approval of medical devices. (Apportionment)

BMGR 651 36 Hours Document and Database Management for Medical Devices

An overview of regulatory requirements for document control and database management for the medical device field. Covers the fundamentals of writing documents that meet regulatory compliance. Equips students for handling document management systems efficiently. (Apportionment)

BMGR 654 36 Hours Quality Assurance for Medical Devices

This course provides students with an in-depth definition of quality assurance and its role within the medical device industry. The course covers the role of assurance during the manufacturing and production stages. Topics will include the step-by-step process of ensuring quality requirements are met for a product or service. (Apportionment)

BMGR 657 36 Hours Technical Writing for Bio-Medical Industries

This course will provide students with an overview and understanding of technical writing for the bio medical industry. The course will cover principle writing methodologies for quality assurance, engineering, manufacturing, and production of a medical device product. Topics will address documentation as related to FDA mandated requirements, ISO standards and for writing GMP procedures. (Apportionment)

BMGR 660 36 Hours Quality Auditing for Medical Devices

This course presents the principles and techniques for assessing the adequacy of a quality system for a medical device manufacturer. Topics include evaluating the quality system as it conforms to FDA regulatory requirements, standards, review of standard audit terms and other audit concepts. (Apportionment)