Expert Insights from AAMI Training

Benefit from the Experienced Perspectives of Leading Experts in the Medical Device and Health Technology Fields with AAMI Expert Insights

AAMI Expert Insights are interactive, virtual presentations from leading industry experts on topics critical topics in health technology, medical device development, and sterilization. New Expert Insights are being developed every month—check back often to find the latest offerings!

Modernize your quality management system under FDA's expected proposed Draft Guidance on Computer Software Assurance for Production and Quality System Software

January 24-26 | 1:00-3:00 PM ET

Unpack the FDA’s planned paradigm shift in their approach to software validation by understanding the history of traditional software validation requirements and the intent of the new Computer Software Assurance (CSA) principles from FDA’s forthcoming draft guidance. Attendees will learn how to modernize your quality management system (QMS) to leverage CSA fundamentals and understand how to implement a risk-based approach to build confidence that your Production, Process and Quality System Software works as intended.

For virtual training courses, please allow one week for US addresses and two weeks for international addresses for shipping of training materials and devices. If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course. If you have any questions, please email education@aami.org.

Benefit from the Experienced Perspectives of Leading Experts in the Medical Device and Health Technology Fields with AAMI Expert Insights

Modernize your quality management system under FDA's expected proposed Draft Guidance on Computer Software Assurance for Production and Quality System Software

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