Published 4/2023
Created by Gerald Rigdon
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz, 2 Ch
Genre: eLearning | Language: English | Duration: 25 Lectures ( 4h 59m ) | Size:
Master the 62304 standard and FDA design controls
Free Download What you'll learn
Learning the Medical Device Software Process
Medical Device Software Regulatory Insights
Mastering the IEC 62304 Standard
ISO 14971 and Risk Management
Safety Critical Software Fundamentals
SiMD and SaMD
FDA and Design Controls
Cybersecurity and Premarket Submissions
Use of Static Analysis for Medical Device Software
Requirements
None
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of training from an industry expert covering safety critical software principles, FDA design controls, the latest FDA draft guidance documents, and deep insight into IEC 62304 and ISO 14971 international standards.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
Who this course is for
Anyone who wants to learn about the medical device software development process
Anyone who wants to master IEC 62304
Anyone who wants to know more about software risk control and ISO 14971
Anyone who wants to know more about safety critical systems
Anyone who wants to learn more about FDA expectations for software
Anyone who wants to be a better software engineer
Homepage
https://www.udemy.com/course/medical-device-software-process-blackbelt/
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