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
  • Lunch and refreshments


In-house training

If you have a group of people to train and a single location that is practical, an expert tutor can deliver training at your premises. Want to know more?


Request an in-house training quote >

Course Flyer

Download the Introduction to Medical Device Software Training course flyer (PDF) 

COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. We’ve been working with all our venues to ensure that COVID secure measures are in place and a member of our team has visited each venue to personally check things over. Enhanced cleaning procedures have been implemented, food and beverage offers adapted, and meeting room layouts have been modified to enable socially distanced events – with anti-bacterial gel and wipes readily available.

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