Quality Assurance Medical Devices (QAMD)

QAMD 400 36 Hours Medical Device Quality Assurance Specialist, Introduction

This course introduces students to the medical device industry in preparation for an entry-level position as a quality assurance specialist. Learn the role and responsibilities of a quality assurance specialist within the medical device industry. Learn about the industry¿s size and scope, current trends, and products used in healthcare settings. (Apportionment)

QAMD 405 36 Hours Regulatory Affairs for Medical Devices

Course will provide students with an in-depth understanding of 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)

QAMD 410 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)

QAMD 415 36 Hours Quality Assurance for Medical Devices

This course provides students with an in-depth overview 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)

QAMD 420 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)

QAMD 425 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)