Regulatory Affairs Courses

Unlike the vast majority of manufacturing industries, the medical device industry must adhere to strict and ever-changing regulatory requirements from the U.S. Food & Drug Administration (FDA) and – for companies with operations and/or markets outside of the U.S. – international regulatory standards.

The regulations, which are intended to assure the safety and efficacy of products, impact all aspects of R&D, product development, clinical testing, production and distribution. In the not-so-distant past, regulatory compliance was viewed as a separate function that was tracked using paper-based systems, but today regulatory and quality considerations are integral to the management and operations of all functions within an organization. For many companies, this integration process has reduced product cycle times and production costs, and it has also increased product quality.

Consequently, specialized educational programs, which are incorporated into more extensive engineering or science curricula, are needed to prepare medical device technicians.  Specialized courses focus on the technologies, systems and methods for integrating regulatory and quality considerations into medical device operations.

The MDIEC colleges have developed two specialized regulatory affairs courses to begin addressing the needs of industry.  These courses, which are summarized below, were developed in close collaboration with industry experts. 

Introduction to Medical Device Regulatory Affairs          (1 Credit)

Introduction to Medical Device Regulatory Affairs – The course provides a base line understanding of the U.S. Food & Drug Administration (FDA) regulation and compliance for medical devices. The coverage of material is specific to medical device manufacturing. Topics include the FDA statutes and regulations, the organization of the FDA, the medical device approval process, laboratory and clinical studies, the introduction to the Quality System Regulations (QSR’s), the FDA inspection process, and international regulation. 

• the laws covering the regulation of medical devices,

• regulations related to the development, manufacturing and approval of medical devices,

• regulatory issues affecting the marketing of medical devices, and

regulatory issues affecting human clinical trials. 

Upon successful completion of the both courses the student will be able to demonstrate mastery of each of the above stated objectives through classroom measures developed by individual course instructors.