Introduction to SaMD, IEC 62304 and IEC 82304-1

ONLINE COURSE - COMING SOON

COMING SOON

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

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We are currently looking for people to validate this course in exchange for free course enrolment.

Please apply to be a validator by clicking on the button which will take you to an application form.

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.

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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.

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, then you can select Direct bank transfer at the very end of the checkout process. You will receive an invoice instead, and you can pay by bank transfer.

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

Would you like to be a validator for this course?

  • We're currently looking for validators for the upcoming Introduction to SaMD, IEC 62304 and IEC 82304-1 online course. Please fill in the form and we will get back to you.
  • When you submit this form, you will be sending personal information to medicaldevicehq.com. To comply with GDPR requirements, we need your consent to store and use the personal data you submit. Your personal data will be used in our customer relationship management system and our ticket system. We will not send you unsolicited emails.
  • Please press the REGISTER button. If you have any questions, don't hesitate to contact us!

    Peter Sebelius
    Founder, Medical Device HQ