Products
-
How Software Testing is Different for Medical Device Software
CourseWebinar presented by our instructor Niranjan Maharajh, for the American Software Testing Qualifications Board, on the key FDA and International regulations that make software testing in the medical device space different than other industries.
Free
-
FDA Overview of the Quality System
CourseLearning modules directly from the FDA providing an overview of the Quality System
Free
-
eLearning: Risk Management for Medical Devices
CourseThis course discusses how risk management is applied in the medical device and in vitro diagnostic (IVD) industries. By the end of the course, you'll be able to conduct ISO 14971 risk management activities for a variety of products and processes.
$595
-
eLearning: Human Factors and Usability Engineering in Medical Device Development
CourseThis course covers core concepts and demonstrates how human factors fit into the larger context of medical device software and hardware development. Lessons also address applicable FDA guidance, and ISO 14971 & IEC 62366-1 standards.
$595
-
eLearning: Software Validation for Medical Devices
CourseThis course covers the requirements for validation of embedded software, digital health apps, software as a medical device, manufacturing software, automated test software, process software, quality system software, and spreadsheets.
$595
-
eLearning: IEC 62304 Medical Device Software — software lifecycle processes
CourseThis course is suitable for anyone that participates in planning, designing and testing medical device software. The course covers the relationship between the IEC 62304 and other standards, compares and contrasts IEC 62304 with FDA expectations.
$299