Introduction to Medical Device Software Training

Gain an understanding of the medical device software lifecycle processes, classification rules and development activities to meet regulatory requirements.

This course is designed to provide you with knowledge of how the Medical Device Regulation (MDR (EU 2017/745)), standards and guidance documents impact medical device software; software as a medical device; and medical devices with software.

It will help you to understand how EN 62304 Medical device software - software lifecycle processes can improve your medical device software development, validation and lifecycle process.

Who should attend?

This course is intended for individuals or organizations involved in software within the medical device industry.


You should have an awareness of Medical Device Regulations and some basic knowledge of medical device software to benefit from this course.

What will I learn?

On completion of this training, you’ll be able to:

  • Define the medical device software terminology
  • Identify the relevant standards, directives, and guidance documents recommended to develop, maintain and validate medical device software
  • Determine if software is covered by an EU Medical Regulation for CE Marking
  • Classify your medical software as per the MDR
  • Apply concepts from the key software standards; including EN 62304 (Medical device software - Software lifecycle processes), EN 60601-1 (Medical Electrical Equipment and Systems) and from the MDR EU 2017/745
  • Evaluate software lifecycle processes and risk management to ensure they are compliant

How will I benefit?

This course will help you to:

  • Understand the key concepts and requirements of EN 62304
  • Gain knowledge of the implementation steps of the medical device software lifecycle processes
  • Correctly classify your medical device software as per the MDR
  • Perform the necessary risk management and software lifecycle management activities 

What's included?

  • You will gain 8 CPD points on completing the course
  • You will be awarded an internationally recognized BSI Training Academy certificate
  • Training course notes


Classroom-based training: Ready when you are

When you’re ready for face-to-face training again, we’re ready to welcome you.

As we all adjust to greater freedom around travel and meetings, we want to reassure you that our training team has worked with venues and tutors to enhance measures to keep you safe.

If you have any questions regarding your booking of a classroom-based training course, please contact or call +44 345 086 9000.