Introduction to Software for Medical Devices and IEC 62304 (ONLINE)

ONLINE COURSE

Learn how to be effective in medical device software development during this self paced, interactive online course.

Take a look at our free short course on software development:

ONLINE COURSE

Course length 15-25 hours
Course fee (per person)
€ 449

Purchase the course access for single user:

Purchase the course access for a group of users:

Course description

This online course focuses on the process of developing software for medical devices. This includes topics such as 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.

The course is 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

Benefits for you

Understand software development

The goal is that upon completion of this course, you should understand how to create and maintain safe software for medical devices throughout their life cycles. You should have a good understanding of key terminology to enable you to actively participate in discussions about software safety classifications and software risk management. In addition to this, you should also understand how IEC 62304 interlinks with other standards such as ISO 14971 and ISO 13485.

Self-paced learning

You will have access to the course for 6 months. The great thing about our online courses is that you can stop, repeat and resume as many times as you like during this time! This provides you with the flexibility to learn how, where and when you want.

Course certificates to prove to regulatory bodies you know your stuff

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.

Christian Kaestner portrait

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.

Course programme

0 Base Course
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 1
  • 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 Base Course
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. Final exam
  • Final exam
10. Course evaluation
  • Course evaluation
11. End of course
  • End of course

NOTE – The course program structure is subject to change

Do you think you will learn more from a classroom course?

This course is also delivered as a blended course, where we combine the best of two worlds. You start with the online course, and then attend a live virtual 1-day classroom session with more in-depth information and practice.

Frequently asked questions

Is the course a live webinar?

The course is not a webinar. This online course is made up of carefully scripted pre-recorded videos to maximize your learning. You can watch it as many times as you like, whenever and wherever you want. You can not download the course though, thus you will need to have an internet connection to take the course.

How long does it take to complete the course?

All in all, the average time to complete the course is 15-25 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 only limitation is the final exam, where you will only have one shot.

How long will I have access to the course?

You will have access to the course for six months.

What if I lose internet connection during the final exam?

You need to have contact with our servers for your results to register on the final exam. If your computer for some reason has a problem and does not allow you to send the result of the final exam to our servers, we recommend that you take a photo or a “print screen” of the screen with your results. E-mail this image to us and we will investigate if you have successfully completed the exam and therefore should receive a course certificate even though the result has not been registered, or if you have to do the final exam again.

Can I fail the final exam?

There is no pass/fail on the final exam (as long as you complete it within the time frame). Your result will be printed on the course certificate which means you can be really proud of your result if you get between 90% and 100% of the answers correct!

Where can I find my course certificate?

The course certificate is available for download after completing the final exam. All you need to do is log in to your account, go to My Courses and scroll down. You will find it under Your Course Certificates.

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What payment methods will you accept?

You can pay using a credit card. You will receive a receipt of payment over email. Reach out to us on support@medicaldevicehq.com if you would like to be invoiced instead. Please note, if you would like to be invoiced, this will take longer and you will incur an invoicing fee.

Can I view the 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.

Do you offer volume discounts?

If you buy more than 5 seats, you may want to consider group purchase, which will give you discounted prices for seats on the course. Reach out to us using the contact form below and let us know how many seats you are interested in purchasing.

Can a colleague and I take the course at the same time?

The course is personal, that means you buy a license for one person. It is also really inexpensive compared to any traditional course with the same scope. If you have more than one person needing the course, please purchase another seat on the course.

Is the instructor accredited or certified to give this training?
There is no certification or accreditation for design control, however the instructor continuously participates in authoring standards such as the IEC 62304 and IEC 82304-1. This ensures the instructor has access to leading edge knowledge and information which is the highest qualification available for teaching the course.
What are the pre-requisites for this course?
There are no pre-requisites for this course but basic understanding of risk management is recommended.

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

Group purchase

You can make a single seat purchase through the shopping cart on Medical Device HQ using a credit card or bank transfer. Please note that, when buying for yourself, the course access is linked to the email address, and the name you enter on checkout.

For a multiple seat purchase, click the button below which will take you to the product page where you can simply enter the number of seats you require.

With a group purchase, we can grant you (or another person you assign) group leader access which enables management of your group, including both adding and removing participants, and receiving progress reports and quiz reports.

Still haven’t decided?

Get in touch with us and get more information:

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