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
Description
The 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of training from an industry expert covering safety critical software principles, FDA design controls, the latest FDA draft guidance documents, and deep insight into IEC 62304 and ISO 14971 international standards.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 Highlights
IEC 62304 in depth
ISO 14971 and software risk management
Software Safety Classification
All phases of the software development lifecycle: Planning, Requirements, Design, Testing, and Release
Software Maintenance
Configuration Management
Problem Resolution
SiMD and SaMD
Late breaking FDA draft cybersecurity requirements
Late breaking FDA draft premarket submission requirements
Static Analysis
Coding Standards
Lifetime Access
Materials
PDFs of all slides for all lectures
A white paper on static analysis for medical device software
62304 checklists
