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COURSE COMPARISON: SaMD, IEC 62304 and IEC 82304-1 VS
Software for Medical Devices and IEC 62304

This guide is to help customers choose which course to take.

Choose “INTRODUCTION TO SAMD, IEC 62304 AND IEC 82304-1” if you:

  • Are working with SaMD software.
  • Are auditing medical device software in general as this course gives you a broader understanding of medical device software.

Choose “INTRODUCTION TO SOFTWARE FOR MEDICAL DEVICES AND IEC 62304” if you:

  • Are only interested in embedded software.
  • Only need a course certificate/training record for IEC 62304.
  • Have less time and want to get a basic understanding of medical device software.

High level content comparison table

Topic INTRODUCTION TO SAMD, IEC 62304 AND IEC 82304-1 INTRODUCTION TO SOFTWARE FOR MEDICAL DEVICES AND IEC 62304
Software and medical devices
Goes into greater detail about different software types, such as SaMD, SiMD and MDSW, compared to the Software for Medical Devices course.
Relates to IEC 60601-1 (electrical safety) which is not part of the SaMD course.
SaMD standards and IEC 82304-1
Detailed explanation of IEC 82304-1 and an introduction to other SaMD applicable standards in a standalone lesson.
A brief introduction to IEC 82304-1 which is about standalone software (SaMD). But it does not have its own lesson as it is out of scope.
IEC62304
Does not include legacy software as it is less likely to be applicable to SaMD.
Includes explanation of legacy software.
Software and risk management
Includes an introduction to cybersecurity based on IEC 81001-5-1.
Nothing specific on cybersecurity.
Software design
Explains software design per IEC 62304 with the addition of an introduction to cloud services and working with AI/ML.
Explains software design per IEC 62304.
Software release and post release management
Explains software release and post release management per IEC 62304. It also includes SaMD release aspects related to IEC 82304-1 and ISO 13485.
Explains software release and post release management per IEC 62304.
Go to the Software online course page
Go to the SaMD online course page

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