Agile Medical Device Software Development
- Online course
- EU and US requirements
- Intermediate - advanced
- Last updated - Oct 2025
Learn how to create an Agile medical device software development process in conformity with IEC 62304 during this self-paced, interactive online course.
Learn what Agile practices are and why they are a useful development methodology.
Learn key concepts from AAMI TIR 45, “Guidance on the use of Agile practices in the development of medical device software”.
Create documentation that complies with IEC 62304 throughout the software development process.
Develop skills to create an efficient and compliant Agile software development process.
Learn how to leverage tools throughout the development process and understand lean approaches to validation of software tools.
Receive downloadable documents and templates, such as:
– Medical device software development procedure based on Scrum (preview here),
– Basic software (tools) validation matrix,
– Identification of IEC 62304 deliverables as product vs conformity documentation.
with SOP and templates
From € 649 € 549/ seat
| Course length | approx. 6-16 hours (11 CPD points) |
Is this the right course for you?
This course is for professionals with a basic understanding of medical device software development, design controls, and IEC 62304. It is not a Scrum/Kanban certification course — the focus is on applying Agile principles in a regulated environment.
If you would like a comprehensive review of IEC 62304, please consider our other courses:
- Software for Medical Devices & IEC 62304
- SaMD – IEC 62304 & IEC 82304-1
- If you need a refresher on IEC 62304, please take a look at our free Quickstart course.
Select your course plan
ONLINE
YOU ARE HERE
€ 649 € 549
Discount ends Sep 30th, 2025
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 € 649
Discount ends Sep 30th, 2025
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
Course overview
It covers topics such as benefits and challenges with Agile methodologies, AAMI TIR45:2023; Guidance on the use of agile practices in the development of medical device software, pros and cons with Kanban vs Scrum, information management, change control, and most importantly, how to design an Agile development process in the medical device industry conforming to IEC 62304 Medical device software – Software life cycle processes.
This course is suitable for professionals in medical device software development who want to deepen their understanding of Agile methodologies or navigate the complexities of integrating Agile practices in a regulated environment.
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).
The course also includes a downloadable SOP and templates, such as:
– Medical device software development procedure(SOP) based on Scrum (preview here),
– Basic software (tools) validation matrix,
– Identification of IEC 62304 deliverables as product vs conformity documentation.
- 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.
Course modules
- Welcome
- What you need to know
- Set your course goal completion date
- Pre-course assessment
- What is Agile?
- Agile pain points
- Customer, stakeholder and product owner
- Define the scope of your Agile process
- What is TIR45?
- The layer approach – Part 1
- The layer approach – Part 2
- Information management and sharing
- Document creation
- Definition of ‘done’ and ‘ready’
- From design inputs to outputs – Part 1
- From design inputs to outputs – Part 2
- Scrum or Kanban
- Scrum terminology – Part 1
- Scrum terminology – Part 2
- Choosing sprint backlog items
- Connect your software development process with other processes
- Documentation approaches – Part 1
- Documentation approaches – Part 2
- Dealing with signatures – Part 1
- Dealing with signatures – Part 2
- How tools can be helpful – Part 1
- How tools can be helpful – Part 2
- Validation of QMS software tools – Part 1
- Validation of QMS software tools – Part 2
- Validation of QMS software tools – Part 3
- Introduction to the process template
- Working with requirements – Part 1
- Working with requirements – Part 2
- Change management
- Pre-final exam
- Final exam
- Course evaluation
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.
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.
Frequently asked questions
This course explains Agile frameworks such as Scrum and Kanban, but its main focus is on how to implement Agile principles within the specific environment of regulated medical software development. You will gain practical insights into adapting these methods for compliance and quality — not a comprehensive certification in Scrum or Kanban.
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 6-16 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).
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.
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.
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.