Description
DescriptionThe ultimate course for mastery of the medical device software process. This course gives you access to 5 hours of training from an industry expert covering safety critical software principles, FDA design controls, the latest FDA draft guidance documents, and deep insight into IEC 62304 and ISO 14971 international standards. You will graduate a blackbelt and walk away with confidence. Often people have fragments of the medical device process in their head but have never been able to put all of the pieces of the puzzle together. This course is unique and comes to the rescue because the training was put together by a software expert who has done the hands-on work and regulatory submissions for Class III implantable medical devices for 16 years. Why spend thousands of dollars elsewhere? You are invited to spend 11 minutes watching the preview video which will explain why you should take this course! Some HighlightsIEC 62304 in depthISO 14971 and software risk managementSoftware Safety ClassificationAll phases of the software development lifecycle: Planning, Requirements, Design, Testing, and ReleaseSoftware MaintenanceConfiguration ManagementProblem ResolutionSiMD and SaMDLate breaking FDA draft cybersecurity requirementsLate breaking FDA draft premarket submission requirementsStatic AnalysisCoding StandardsLifetime AccessMaterialsPDFs of all slides for all lecturesA white paper on static analysis for medical device software62304 checklists
