CE Marking Medical Devices with Software Training

To help organizations understand how directives apply to their software, how software is classified and how to achieve and maintain a CE mark for their medical device software.

The steps you take to define, classify, develop, and test your software is critical to both your business and patient health when it applies to a medical device. Achieving and maintaining a CE mark for your medical device software therefore becomes essential to keeping your product marketable.

This course will help you learn how the medical device directives apply to your software, how your software is classified, and how to develop and maintain it with a CE mark in mind. You will learn how to evaluate your software and processes so you’ll know what to do during the software life-cycle to meet the medical device directives.

Who should attend?

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

What will I learn?

Upon completion of this training, delegates will be able to:

  • Identify the relevant directives, standards, and guidance documents recommended to develop, maintain, and validate medical software according to the state of the art
  • Determine if your software is covered by an EU medical directive for CE Marking, and if so how you can classify it
  • Apply concepts from the key software standards and guidance documents, including BS EN 62304, BS EN 82304, MEDDEV 2.1/6, and BS EN 60601-1
  • Develop the basic knowledge necessary to evaluate software lifecycle processes and risk management to ensure that they are compliant with the medical directives and regulations Understand the new requirements of the EU Medical Devices Directive (MDR)
  • Understand the new requirements of the EU Medical Devices Directive (MDR)

How will I benefit?

This course will help you:

  • Know what to do during software development and maintenance to meet the medical device directives
  • Properly classify your software based on medical device directive parameters
  • Effectively plan software risk management, development, testing, maintenance and problem resolution
  • More efficiently achieve a CE mark for you medical device containing software
  • Assess risks that may impact your software

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 Guide

Download the CE Marking Medical Devices with Software course guide (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. In the event of a classroom-based course being deemed unsafe, your training booking will be automatically transferred to online delivery using our highly-interactive virtual classroom - Connected Learning Live.

If you have any questions regarding your booking, please contact training@bsigroup.com or call +44 345 086 9000.

Booking a course delivered via Connected Learning Live?

Take advantage of our exclusive offers, only available in July and August 2020*

Book a July or August Connected Learning Live course date and you’re entitled to unlock one of the following benefits:

  • Option 1: Get 50% off a second delegate booking fee
    Offer applicable to public courses delivered via Connected Learning Live in July and August 2020 only. Second delegate must attend the same course date
  • Option 2: Save £500 on a BSI Diploma in Quality Management
    Offer applicable to delegates that have booked a public course delivered via Connected Learning Live in July and August 2020 only

Contact our training team today to find out more and book your place. Call +44 345 086 9000 or email training@bsigroup.com

*Terms and conditions: Applies to all public BSI UK training courses, taking place in July and August 2020 via Connected Learning Live only. Call our training team on +44 345 086 9000 or email training@bsigroup.com for more information. Second delegate must attend the same course date as the first delegate. Moves, changes and cancellations are not permitted. Payment required or invoice issued at the time of bookings. This offer does not apply to BSI re-sellers or Cybersecurity and BRCGS courses. Offer is for new BSI UK training bookings only. Offer is not to be used in conjunction with any other offer. Offer subject to availability of training courses. Bookings are non-transferable. All other terms and conditions for training courses apply.