The Need for Specialized Education and Training

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). Companies with operations and/or markets outside of the U.S. also must adhere to 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 i ntegral 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.