Introduction to SaMD, IEC 62304 and IEC 82304-1


Learn how to create and manage high quality, safe Software as a Medical Device (SaMD) during this self-paced, interactive online course.

Online course
Course length
20-25 hours
Course fee (per person)
€ 449

Unsure whether this course or the Introduction to Software for Medical Devices and IEC 62304 online course is right for you?

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Course description

This online course is an adaptation of our existing popular course Introduction to Software for Medical Devices and IEC 62304 with a special focus on developing Software as a Medical Device (SaMD). 

Topics of the course include how to efficiently plan and document software development, getting requirements right, how to approach software architecture and software risk management, and how to perform software safety classification correctly . 

SaMD specific topics include software types and terminology, product requirements in IEC 82304-1, how to manage cybersecurity and artificial intelligence.

The course looks at the development aspects of the IEC 62304 standard. It also includes an introduction to the IEC 82304-1 standard and its relation to ISO 13485 (quality management). In the course, you will also learn about the relationship to ISO 14971 (risk management) when developing medical device software.

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

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.

Benefits for you

Checkmark MDHQ Learn from those who wrote the standard

Christian Kaestner is a long time member of the international committee that is authoring the IEC 62304 and also actively participated in the creation of IEC 82304-1. In his course, you will learn the meaning of the requirements from a first hand source.

Checkmark MDHQ 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 and when you want.

Checkmark MDHQ Course certificate to prove to regulatory bodies you know your stuff

Auditors may look for training on the IEC 62304 and IEC 82304-1. 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 the standards or not.

Course programme

  • Welcome
  • What you need to know
  • Set your course goal completion date
  • Pre-course assessment quiz
  • What is software and what makes it different
  • Software types and terminology
  • Introduction to the regulatory landscape
  • Introduction to classification of medical devices and software
  • Introduction to risk
  • SaMD relevant standards
  • The relationship between IEC 82304-1 and ISO 13485
  • Product requirement in IEC 82304-1
  • 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
  • Understanding software risk management
  • Cybersecurity
  • 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
  • Development planning – Part 1
  • Development planning – Part 2
  • Development planning – Part 3
  • Configuration management
  • SOUPs, how to management and document – Part 1
  • SOUPs, how to management and document – Part 2
  • Software requirements – Part 1
  • Software requirements – Part 2
  • Software architecture – Part 1
  • Software architecture – Part 2
  • Software architecture and cloud services
  • Quality control of cloud services
  • Software detailed design
  • Software design – AI/ML – Part 1
  • Software design – AI/ML – Part 2
  • Software unit implementation
  • Software integration testing
  • Software system testing
  • Software release per IEC 62304
  • SaMD product release per IEC 82304-1/ ISO 13485
  • Maintenance plan
  • Problem resolution – the process
  • Change control
  • Course evaluation
  • Learn more in a live virtual class
  • The virtual class product
  • Get your questions answered in the live virtual class

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 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.

You will have access to the course for six months.
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.
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!
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.

We offer a number of payment methods including credit card, GooglePay, ApplePay, PayPal, wire transfer/invoice depending on the country you are buying from. If you cannot find your country on the list at checkout or you are not given wire transfer as a payment method, you can submit your order via our invoice order form.

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

If you purchase five seats for the same online course at the same time, we will give you one extra seat for free on that same course (e.g. buy 5 get 6, buy 10 get 12, etc). The free seat is assigned manually after the order has been received.

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.

There is no certification or accreditation for software development, however the instructor continuously participates in authoring the IEC 62304 and IEC 82304-1 standards. This ensures the instructor has access to first hand information and understanding of the meaning of the standard’s requirements. This is the highest qualification available for teaching the course.

There are no pre-requisites for this course but basic understanding of risk management is recommended.

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 at 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.

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