This course explores testing strategies and study design considerations for diagnostic AI models requiring premarket clearance by regulatory bodies like the USA FDA, EU MDR, and those adhering to ISO 13485 standards. Focusing on detection AI, the training covers bench and clinical testing, emphasizing their roles in bias mitigation, clinical effectiveness, and regulatory compliance.

This course offers a comprehensive overview of Quality Management System (QMS) considerations essential for the development and regulatory approval of diagnostic AI models classified as medical devices. It is specifically tailored for AI models requiring premarket clearance by the U.S. FDA, EU MDR, and other regulatory bodies that mandate adherence to ISO 13485 standards. 

Have you ever accused your associates of over-reacting to the slightest changes in production, corrective actions, complaint monitoring, or servicing? Or worse yet, have folks in your organization over-looked obvious trends in those key areas? This webinar will provide a valid statistical procedure that is so simple, you won’t even know that you are applying statistics -- all the time.  Statistical Process Control (SPC) charts are highly graphical tools applied in world-class organizations.

Machine learning systems can fail in unusual and unexpected ways, when compared to traditional software products. This course will highlight those differences and will also provide a snapshot of the current standards and regulatory landscape associated with the risk of machine learning enabled medical devices.

The FDA recognizes the benefits of harmonization with other regulatory authorities, and it has determined that ISO 13485:2016, the globally recognized standard for a medical device organization’s QMS, is substantially similar to the current version of 21 CFR Part 820 which became effective in 1996.

SaMD (Software as a Medical Device) is one of the fastest growing types of Medical Devices in the world.  This is creating a unique situation where traditional software companies are now becoming Medical Device Manufactures (MDMs) and traditional MDMs are developing more and more software.  

Join us as we go over all the major updates regarding processing (gaseous sterilization, liquid chemical sterilization, and high-level disinfectants) for reusable medical devices. The current version of AAMI ST58 was due for revision, as it was last updated in 2013. These updates will improve safety for personnel performing the processing and enhance patient outcome and experiences with the newly revised guidance.

This comprehensive training is specifically designed for HTM leaders, equipping them with the knowledge and strategies needed to achieve regulatory compliance in healthcare technology management (HTM). It covers relevant regulatory agencies, their expectations, and effective strategies for meeting or exceeding compliance standards. By implementing proven strategies, HTM leaders can drive continuous survey readiness, reduce stress levels, and minimize unnecessary work for themselves and their teams.