Unsure whether this course or the Introduction to Software for Medical Devices and IEC 62304 online course is right for you?
Click here for a course comparison.
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
€ 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
€ 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
CONTACT US
Tailored training to meet your company's needs
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).
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.
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).
Direct access to standards authorsOur 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-keepingParticipants’ 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 learningOur 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.
NOTE – The course program structure is subject to change
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.
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.
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.
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
Choose your course options below
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
Oops, I actually wanted to buy seats for several people. Take me to the right place.
Choose your course options below
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
Oops, I actually wanted to buy seats for several people. Take me to the right place.
Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.