Introduction to Software for Medical Devices and IEC 62304 (ONLINE)
ONLINE COURSELearn how to be effective in medical device software development at your own pace.
Take a look at our free short course on software development:
ONLINE COURSE |
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| Course length | 6-8 hours |
| Course fee (per person) |
€ 449
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Course description
This online course focuses on developing software for medical devices. This includes getting requirements right, how to approach software architecture and how to interact with system risk management (including getting software safety classification correct).
Even though the course is an introductory course, it’s intended to be practical and suitable for anyone working with software development, such as R&D engineers, quality assurance department and people auditing software development processes.
The course covers an orientation of the software development process according to the standard IEC 62304 and its relation to other standards such as ISO 14971, IEC 82304–1.
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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
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 will look for evidence that you are competent in software development. Upon completion of the course, you will receive a certificate that you can show auditors.
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 structure
0 Base Course
Lesson 1. Introduction to medical device software
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Lesson 2. Introduction to IEC62304
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Lesson 3. Requirement and risk management
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Lesson 4: Planning - Waterfall/Agile/V-modell
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Lesson 5. Software architecture
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Lesson 6. Configuration management
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Lesson 7. Software development environment and SOUP
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0 Base Course
Lesson 8. Software risk management
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Lesson 9. Design (and coding)
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Lesson 10. Test
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Lesson 11. Release and maintenance
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Lesson 12. Final exam
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Lesson 13. Course Evaluation
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NOTE – The course program structure is subject to change
Frequently asked questions
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.
All in all, the average time to complete the course is 6-12 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.
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?
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 our professional plan, 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.
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?