Medical Device Software Process Blackbelt

Master the IEC 62304 standard, FDA design controls, and risk management of medical device software

Ratings: 4.43 / 5.00




Description

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of training from an industry expert covering safety critical software principles, FDA design controls, the latest FDA draft guidance documents, and deep insight into IEC 62304 and ISO 14971 international standards.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


What You Will 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

Who Should Attend!

  • 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