SOFTWARE FOR MEDICAL DEVICES AND IEC 62304

ONLINE + LIVE VIRTUAL CLASSROOM TRAINING - BLENDED COURSE

This is a blended (online + live virtual classroom session) course designed to teach you how to develop and maintain software for medical devices safely and according to the IEC 62304 standard.

BLENDED COURSE

Course length approx.
18-24 hours
Next classroom session
9-10 Mar 2021
1PM – 5PM CET
Course fee (per person) € 1099

Course description

This blended (online + live virtual) course focuses on the process of developing software for medical devices. Topics covered include: how to efficiently plan and document software development, getting requirements right, how to approach software architecture and software risk management, how to perform software safety classification correctly and working with SOUP/OTS software.

 The course covers all aspects of the IEC 62304 standard and the relationship between the IEC 62304 and other standards such as ISO 14971, IEC 60601-1 and IEC 82304-1.

It is intended to be practical and suitable for anyone working with software development, such as R&D engineers, quality assurance department and auditors of software development. The course does not cover actual coding.

What is a blended course?

Our blended learning courses combine the best of two worlds: online training with live virtual classroom sessions. You get to learn the theory first at your own pace, during the online course, before applying theory in practice with the guidance of the expert instructor. 

The online training provides flexibility in how you learn so you can learn in a way that suits you best. You can access it whenever and wherever you want and you can stop, start and repeat the lessons and quizzes as often as you like. To help maximise your learning we assess your knowledge and understanding at the start and throughout the online training, culminating with a final exam at the end. 

The classroom session is highly interactive and focuses on applying the theory in practice with the guidance of the expert instructor. There are real life case scenarios to work through and plenty of time for discussions and questions!  

Christian Kaestner - Instructor on Software Development and IEC 62304 online course

Christian Kaestner is a consultant and entrepreneur with a wealth of knowledge about the medical device industry. He is an expert member of the project team authoring IEC 62304 and also actively participated in the creation of IEC 82304-1.

He has extensive experience of medical device development and, as a software developer, a strong dedication to software development. In the software domain he has worked in many roles such as software developer, project manager, auditing and quality management.

Benefits for you

Become confident in doing software development work

The course is practical. You will be working on realistic tasks relating to the software lifecycle according to IEC 62304, both in groups and individually during the live virtual classroom session. The goal is that by the end of the course you will understand how to create and maintain safe software for medical devices throughout their life cycles

Templates to give you a head start

The course includes useful templates for software development. You can customize or learn from them and use in your company. This can give you a head start on software development if your company is not up and running already in this field.

Start right away

You can get started on the online course after registration and invoicing.

Course certification

Auditors may look for training on the IEC 62304. You will have a nice-looking course certificate to present if you get asked the question during an audit. Avoid the discussion with the auditor of whether you know IEC 62304 or not.

Get information from the source

The instructor is an expert member of the project authoring the standard. If you are looking for a course about software development, make sure you choose a course where the instructor has first-hand information.

Course programme

This blended course is done in two parts: an online course with a final exam and a classroom session.

Online course structure

0. Opening
1. Introduction
  • Welcome
  • What you need to know
  • Set you course completion date
  • Pre-course asssessment quiz
2. Introduction to software and medical devices
  • What is software and what makes it different?
  • General software terminology
  • Introduction to the regulatory landscape
  • Introduction to classification of medical devices and software
  • IEC 62304 in relation to other standards
  • The gap between IEC 60601-1 and IEC 62304
  • IEC 82304-1 – A product standard for health software
  • Introduction to risk
3. Introduction to IEC 62304
  • Scope and general terminology – Part
  • Scope and general terminology – Part 2
  • General requirements (IEC 62304)
  • Development process and compliance
  • Software safety classification – Part 1
  • Software safety classification – Part 2
  • Software safety classification – Part 3
  • Legacy software
4. Software risk management
  • Understanding software risk management
  • Development process as risk control – Part 1
  • Development process as risk control – Part 2
  • Software risk management in IEC 62304 – Part 1
  • Software risk management in IEC 62304 – Part 2
  • Software causes
  • Software risk control measures
5. Software planning
  • Development planning – Part 1
  • Development planning – Part 2
  • Development planning – Part 3
  • Configuration management
  • SOUPs – How to manage and document – Part 1
  • SOUPs – How to manage and document – Part 2
6. Software design
  • Software requirements – Part 1
  • Software requirements – Part 2
  • Software architecture – Part 1
  • Software architecture – Part 2
  • Software detailed design
  • Software unit implementation
0. Opening
7. Software testing
  • Software integration testing
  • Software system testing
8. Software release and post release management
  • Software release
  • Maintenance plan
  • Problem resolution – the process
  • Change control
9. Pre-classroom survey
  • Pre-classroom survey
10. Final Exam
  • Final Exam
11. Course Evaluation
  • Course evaluation

Classroom session

1-day or 2-half days live virtual instructor-led classroom sessions working on case studies & real-life scenarios.

Frequently asked questions

Is the course a live webinar?

The blended course comprises two parts: the online course and a live virtual classroom session.

The online course is made up of carefully scripted pre-recorded videos to maximize your learning. The live virtual classroom session is a virtual face-to-face 1-day session where you will be interacting with the instructor and course participants via Zoom. You are required to be visible on video when taking the classroom session.

Can I view the online course on a mobile device?

Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.

How long does it take to complete the course?

All in all, the average time to complete the blended course is 18-24 hours. The online course takes approximately 10-14 hours but you can complete it in less time if you don’t repeat any of the lessons and have just one attempt at the quizzes.

Please note, you don’t have to watch the whole course at once. In fact, you can pause, resume, and replay as often as you like. The live virtual classroom is a 1-day session and lasts approximately 8 hours.

Where can I find my course certificate?
You will be receiving a course certificate after completing the final exam. The course certificate is available when you log in to your account. Go to My Courses, and scroll down. You will find it under Your course certificates.

After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email.

Do you offer volume discounts?
If you buy more 3 or more seats, we do. Use the contact form to request a quote for 3 or more participants.
How long will I have access to the course?
You will have access to the online course for six months.
What is the maximum number of participants in the live virtual classroom?
The maximum number of participants for the live virtual classroom session is 8.
Can I fail the final exam?
No, you cannot fail the final exam. However, it is required to achieve 85% or more on the final exam to be allowed to attend the classroom session. The check-point quiz questions that are available during the online course will be a good marker on what you will get on the final exam.

If you do not achieve 85%, the final exam can be reset for an administrative fee of 50 EUR and you can take it again.

What are the pre-requisites for this course?
There are no pre-requisites for this course.
Is the instructor accredited or certified to provide training?

There is no certification or accreditation for software development, however the instructor is an expert member of the project authoring the standard. If you are looking for a course about software development, make sure you choose a course where the instructor has first-hand information.

What payment methods will you accept?
After signing up on the course registration page, we will send you the invoice for the course.

Testimonials

I found this a very informative introductory course, providing valuable insight into ways of interpreting and working with IEC 62304. It is a very well structured course and includes real scenarios of software development, useful links, templates and examples of tools used in the industry.

Stacey Finn

Senior Quality Engineer, Philips (Remote Diagnostics Technologies)

This is one of the most comprehensive IEC 62304 online courses available in the market. The content is excellent and covers all aspects of the standards as well as practical applications to implement the standard. I highly recommend this course to anyone looking for IEC 62304 training.

Kamran Younis

Head of Quality Assurance, ConvergeHEALTH by Deloitte

Would you prefer a course held on your premises?
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.

Register for a course

If you are already prepared to take a course, you can register for one of our upcoming blended courses. You’ll have 24 hours to cancel your reservation in case you can’t come.

Get more info about the course