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.
- Recognize the fundamentals of a medical device manufacturer quality management system
- Identify the primary influences impacting a quality management system
- Identify the FDA Quality System Regulation and ISO 13485:2016 obligations relative to “Management with Executive Responsibility” (MWER) or “Top Management”
- Recognize the resources available to gain greater insight into the fulfillment of these obligations
- Recognize how to fulfill many of these obligations
By completing/passing this course, you will attain the certificate Medical Device Certificate
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