Medical device regulators from around the world have recognized the importance of top management’s commitment to quality as essential to establishing and maintaining an effective quality management system.  Top management of medical device manufacturers have been held legally responsible for quality management system failures.  Top management is not simply the most responsible corporate officials, but also those responsible for site-specific activities throughout the organization.  When considering action, regulatory authorities may use a “wide net” when identifying top management.  It is essential that top management of all levels of an organization understand its obligations to quality.  Cognizant of the value of top management’s time, this approximately one-and-a-half-hour course was designed to efficiently focus on top management obligations relative to FDA’s Quality System Regulation and ISO 13485:2016.  This course does not simply focus on the requirements of the regulation and standard but provides insight into the expectations of the framers of those documents through discussions of the preamble to the quality system regulation, and TC 210 guidance relative to ISO 13485:2016.  These discussions and supporting examples provide valuable insight into how to comply with the cited regulation and standard requirements.   Read more

This course provides a comprehensive overview of the United States medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way the United States is utilizing MDSAP. Read more

The pre-submission or Q-Sub program is a voluntary mechanism to get FDA’s feedback on specific questions necessary to guide product development and/or application preparation. This course provides instruction critical to prepare for a successful meeting with the FDA. Read more