SaMD, IEC 62304 and IEC 82304-1
- Online course
- EU and US requirements
- Beginner - intermediate
- Last updated - Sep 2025
Learn how to create and manage high quality, safe Software as a Medical Device (SaMD) during this self-paced, interactive online course.
| Course length | approx. 10-29 hours (21 CPD points) |
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Select your course plan
QUICKSTART
FREE
Average completion time 1-3 hours
Total video duration 32 minutes
Number of quizzes 5
30 days access to the course
Digital course companion
ONLINE
YOU ARE HERE
€ 499
Average completion time 10-29 hours
Total video duration 7.5 hours
CPD points 21
Number of quizzes 37
Final exam
Course certificate
Ask the instructor
6 months access to the course and instructor
ONLINE LIFETIME
€ 599
Average completion time 10-29 hours
Total video duration 7.5 hours
CPD points 21
Number of quizzes 37
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
BLENDED
€ 1149
Average completion time 17-36 hours
Total video duration 7.5 hours
CPD points 28
Number of quizzes 37
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Printed course companion
Classroom sessions (2 * 3.5 hours)
Templates
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
Course overview
This online course is an adaptation of our existing popular course Software for Medical Devices and IEC 62304 with a special focus on developing Software as a Medical Device (SaMD).
SaMD specific topics include software types and terminology, product requirements in IEC 82304-1, introduction to 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.
It is made up of pre-recorded videos, quizzes, and a final exam. There is also a downloadable course companion within the course. You will receive a course certificate upon successful completion of the course.
If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access (conditions apply).
- This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training.
- Christian Kaestner is a member of the Swedish standardisation committee TC 62/SC 62A and is actively involved in authoring the updated IEC 62304 at the international level.
Benefits for you
Direct access to standards authors
Our courses are developed by members of the standardization committees involved at both national and international levels, ensuring you receive first-hand knowledge and insights.
You can ask our instructors questions during the online course thereby gaining exclusive up-to-the-minute information.
Training effectiveness and record-keeping
Participants’ knowledge is assessed through pre-training quizzes and a final exam, enabling a true measure of the training’s effectiveness.
Furthermore, we provide records, including the final exam score and course certificate, to satisfy ISO 13485 requirements, ensuring compliance and accountability.
Self-paced and bite-sized learning
Our interactive online courses offer the flexibility to learn at your own pace. The high-quality videos are designed in bite-sized segments, making it easier to grasp and retain information.
This format provides a convenient alternative to traditional classroom courses accommodating different learning styles and preferences.
Course modules
- 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
- Wrap up
- Final exam
- 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
Do you want this course on your internal LMS? Contact us
Frequently asked questions
All in all, the average time to complete the course is 10-29 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.
If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access to the course if you complete the final exam within 6 months of enrolment (conditions apply).
Yes, you can download a course companion within the online course. It contains a selection of key slides from the course and is in PDF format.
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.
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 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.
Medical Device HQ is proud to be an accredited CPD provider, demonstrating our commitment to your continued professional development with high-quality training courses.
A CPD record showcases your professional growth, boosts confidence in your abilities, and can be presented to management for better career opportunities.
As a participant of a CPD certified course, you will receive a certificate awarding you CPD points following completion of the training.
Upon completion of the course, you are awarded 21 CPD points for the online course and 28 CPD points for the blended course.
Your course certificate will display the exact number of CPD points. Read more.
Reviews
Medical Devices
InViva Healthcare Management
Director
Vision RT
Lemberg Solutions
Haermonics B.V.
Insparya Hair Company
NSAI
Phillips Medisize
and Software Development
MagForce, The Nanomedicine Company
Annalise.ai
He is currently involved in the authoring of the updated IEC 62304 as part of TC 62/SC 62A, and serves as convener of TC 62/ahG9, a group tasked with finding consensus regarding the understanding of AI-related terms and concepts (e.g., ISO/IEC 22989-2) in IEC TC 62.
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.
Group purchase
If you wish to purchase two or more seats on the same online course, click the ‘Buy multiple seats’ button below which will take you to the product page where you can simply enter the number of seats you require.
If you purchase three seats or more on the same online course at the same time, you will be added to the Professional Plan for free. This means a group account will be created for you that you can manage. You will be able to track the participant’s course progress from your group account and view quiz results.
It is the person that places the order who will be our single-point-of-contact and group leader for the group account. If you wish to change this to someone else later on, you can email us at support@medicaldevicehq.com.