AI in medical devices:
Foundations, Regulation, and Implementation
- Online course - coming soon
- EU and US requirements
- Beginner - intermediate
- Last updated - Feb 2026
Understand what artificial intelligence truly is – and what sets it apart from traditional medical device software.
This course offers a practical, regulation-oriented introduction to AI in medical devices, assisting you in navigating technical concepts, risks, and compliance expectations without getting bogged down in code or mathematics.
- Understand what AI is - and what it is not - in a healthcare and medical device context.
- Use AI terminology correctly, including concepts such as bias, explainability, transparency, and performance drift.
- Grasp the technical fundamentals that influence AI behaviour and limitations.
- Interpret regulatory expectations for safe and compliant AI development.
- Incorporate AI-specific considerations into your existing design control and risk management processes.
From € 649/ seat
| Course length | approx. 5-15 hours |
Select your course plan
ONLINE
YOU ARE HERE
€ 649
Average completion time 6-16 hours
Total video duration 4 hours
Number of quizzes 18
Final exam
Course certificate
Ask the instructor
6 months access to the course and instructor
Digital course companion
ONLINE LIFETIME
€ 749
Average completion time 6-16 hours
Total video duration 4 hours
Number of quizzes 18
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Digital course companion
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
Total video duration
Course access
Course overview
This online course introduces artificial intelligence from the perspective of medical device development, regulation, and lifecycle management.
The course explains key AI concepts and terminology using internationally recognised sources, including:
- ISO/IEC 22989 – Artificial intelligence concepts and terminology
- ISO/IEC 23894 – Guidance on risk management for AI
- ISO/IEC 42001 – AI management systems
- Guidance documents from the FDA and IMDRF
- The EU AI Act
This course is designed for professionals involved in medical devices who need to understand, manage, or oversee AI development – without becoming AI developers themselves.
This course will not teach you how to program AI models or perform advanced statistical analysis. Instead, it focuses on what you need to understand to manage AI-based systems safely, responsibly, and in compliance with regulations.
The online course 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).
- 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.
Course modules
- Welcome
- What you need to know
- Set your course goal completion date
- Pre-course assessment
- What is AI?
- AI use cases in medical technology
- Definitions and proper context
- Key terminology: AI, ML, and Deep Learning – Part 1
- Key terminology: AI, ML, and Deep Learning – Part 2
- Opportunities and challenges of AI in healthcare
- The AI System Lifecycle
- Bias
- The Black Swan
- Data management
- Model training and validation
- Explainability and transparency
- Performance drift and continuous learning
- Global regulatory principles for AI
- IMDRF’s frameworks and GMLP principles
- FDA’s approach to AI/ML-Based software
- European Union: MDR, IVDR, and the AI Act
- EU AI Act specifics
- Comparing U.S., EU, and IMDRF approaches
- Cybersecurity and data protection expectations
- Quality management aspects
- Integrating AI into design controls
- Risk management for AI systems
- Ethical and human factors considerations
- Verification, validation, and clinical evaluation
- AI development and IEC 62304
- Post-market surveillance and model maintenance
- Emerging technologies: generative AI and digital twins
- The future regulatory horizon
- Final summary and key takeaway
- Pre-final exam
- Final exam
- Course evaluation
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.
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.
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.
Apply to become a validator for this course
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.
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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 TBD, 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).
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.
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.
Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.
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 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.
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.
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 completing the course, you can claim 11 CPD hours (11 CPD points) for the online course.
Your course certificate will display the earned CPD hours.
Reviews
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.