Introduction to SaMD, IEC 62304 and IEC 82304-1

Learn how to create and manage high quality, safe Software as a Medical Device (SaMD) during this self-paced, interactive online course.

Online course

From € 449/ seat

See pricing plan

Course length approx. 10-29 hours
(21 CPD points)

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ONLINE

YOU ARE HERE

€ 449​

Checkmark MDHQ  Average completion time​  10-29 hours

Checkmark MDHQ  Total video duration​ 7.5 hours

Checkmark MDHQ  CPD points 21

Checkmark MDHQ  Number of quizzes​ 38

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ 6 months access to the course and instructor

ONLINE LIFETIME

€ 549

Checkmark MDHQ  Average completion time​  10-29 hours

Checkmark MDHQ  Total video duration​ 7.5 hours

Checkmark MDHQ  CPD points 21

Checkmark MDHQ  Number of quizzes​ 38

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ Ask the instructor

Checkmark MDHQ Lifetime access to the course and instructor

BLENDED

€ 1099 ​

Checkmark MDHQ  Average completion time​  17-38 hours

Checkmark MDHQ  Total video duration​ 7.5 hours

Checkmark MDHQ  CPD points 28

Checkmark MDHQ  Number of quizzes​ 38

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ  Lifetime access to the course and instructor

Checkmark MDHQ  Printed course companion

Checkmark MDHQ  Classroom sessions (2 * 3.5 hours)

Checkmark MDHQ  Templates

IN-HOUSE TRAINING​

CONTACT US​

Tailored training to meet your company's needs
Average completion time
The average course completion time varies based on prior knowledge and individual course goals. It includes video viewing, quizzes, and final exam.
Total video duration
This is the total recorded video duration for the whole course (excludes quizzes and exam). Participants often rewatch videos for better comprehension.
CPD points
This course is CPD-accredited. You will be able to claim CPD points and get a certificate with confirmation of CPD hours
Number of quizzes
This is the total number of quiz questions in the course. They are spread throughout the course, typically at the end of each lesson. They can, for example, be multiple choices, true/false, or short written answers.
Course access
Lifetime access to the online course is granted upon completion of the course and final exam within six months from enrollment. Access continues as long as the course remains available on the website without significant changes.
Final exam
The final exam consists of 30-45 randomly selected quiz questions, taken once under timed conditions, for verification of training and course certificate issuance. No pass/fail, but the score is recorded in training record.
Course certificate
Upon completion of the final exam, two course certificates are issued: 1) A social media-friendly certificate that can be easily shared on LinkedIn. 2) A PDF course certificate, including the final exam score, suitable for your training records. When attending the blended course, a course certificate covering both the online course and the classroom session is also issued.
Ask the instructor
Enrolled learners can utilize the comment fields in each lesson to ask questions, which are answered by the course creator. Please note that the course creator provides responses to questions of a generic nature and they do not substitute regular consulting assignments.
Digital course companion
The personal printed course companion serves as a comprehensive summary of the online course, condensing the key concepts into concise bullet points accompanied by relevant images and helpful flowcharts.
Classroom sessions (2 * 3.5 h)
The classroom sessions, held over two half-days (3.5 hours each), provide a highly interactive environment for applying the theory learned during the online course. Guided by an expert instructor, there are real-life case scenarios to work through and plenty of time for discussions and questions. It's an opportunity to further enhance understanding and practical skills in a collaborative setting.
Templates
Our exclusive collection of time-saving templates are designed to enhance the online course experience. These templates provide practical knowledge and assist in implementing corresponding requirements to improve operations.
€ 449
10-29 hours
7.5 hours
21 CPD points
38
6 months access
You're here
€ 549
10-29 hours
7.5 hours
21 CPD points
38
Lifetime access
€ 1099
17-38 hours
7.5 hours
28 CPD points
38
Lifetime access
Contact us
Tailored training to meet your company’s needs

Course overview

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).

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Benefits for you

Checkmark MDHQ 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.

Checkmark MDHQ 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.

Checkmark MDHQ 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
  • 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 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)

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 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 earn CPD points and receive a certificate confirming your CPD hours.

Upon completing the course, you can claim 21 CPD hours (21 CPD points) for the online course, and 28 CPD hours for the blended course.

Your course certificate will display the earned CPD hours.

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.

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.

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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.

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Choose your course options below

Multiple seats

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.

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