INTRODUCTION TO SOFTWARE FOR MEDICAL DEVICES AND IEC 62304 (ONLINE)

Learn how to be effective in medical device software development during this self paced, interactive online course.

Online course

From € 449/ seat

See pricing plan

Course lengthapprox. 9-25 hours

Learn how to be effective in medical device software development during this self paced, interactive online course.

ONLINE COURSE

Course length15-20 hours
Course fee
(per person)
from € 449
Purchase the course access for single user:
Purchase the course access for a group of users:

Select your course plan

ONLINE

YOU ARE HERE

€ 449​

Checkmark MDHQ  Average completion time​  9-25 hours

Checkmark MDHQ  Total video duration​ 6.5 hours

Checkmark MDHQ  Number of quizzes​ 34

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ  Digital course companion

Checkmark MDHQ 6 months access to the course and instructor

ONLINE LIFETIME

€ 549

Checkmark MDHQ  Average completion time​  9-25 hours

Checkmark MDHQ  Total video duration​ 6.5 hours

Checkmark MDHQ  Number of quizzes​ 34

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ Ask the instructor

Checkmark MDHQ  Digital course companion

Checkmark MDHQ Lifetime access to the course and instructor

BLENDED

€ 1099 ​

Checkmark MDHQ  Average completion time​  16-32 hours

Checkmark MDHQ  Total video duration​ 6.5 hours

Checkmark MDHQ  Number of quizzes​ 34

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ  Digital course companion

Checkmark MDHQ  Lifetime access to the course and instructor

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.
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
9-25 hours
6.5 hours
34
6 months access

You're here

€ 549
9-25 hours
6.5 hours
34
Lifetime access
€ 1099
16-32 hours
6.5 hours
34
Lifetime access
Contact us
Tailored training to meet your company’s needs

Course overview​

This online course focuses on the process of developing software for medical devices. It includes topics such as how to efficiently plan and document software development, getting requirements right, how to approach software architecture and software risk management, how to perform software safety classification correctly and working with SOUP/OTS software.

It covers all aspects of the IEC 62304 standard and the relationship between the IEC 62304 and other standards such as ISO 14971, IEC 60601-1 and IEC 82304–1.

 

The course is suitable for anyone working with software development, such as R&D engineers, quality assurance department and auditors of software development. 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).

Unsure whether this course or the Introduction to SaMD, IEC 62304 and IEC 82304-1 online course is right for you? Click here for a course comparison.

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.

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 you course completion date
  • Pre-course assessment quiz
  • What is software and what makes it different?
  • General software terminology
  • Introduction to the regulatory landscape
  • Introduction to classification of medical devices and software
  • IEC 62304 in relation to other standards
  • The gap between IEC 60601-1 and IEC 62304
  • IEC 82304-1 – A product standard for health software
  • Introduction to risk
  • 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
  • Legacy software
  • Understanding software risk management
  • 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 manage and document – Part 1
  • SOUPs – How to manage and document – Part 2
  • Software requirements – Part 1
  • Software requirements – Part 2
  • Software architecture – Part 1
  • Software architecture – Part 2
  • Software detailed design
  • Software unit implementation
  • Software integration testing
  • Software system testing
  • Software release
  • Maintenance plan
  • Problem resolution – the process
  • Change control
  • Course evaluation

NOTE – The course program structure is subject to change

Frequently asked questions

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 standards such as the IEC 62304 and IEC 82304-1. This ensures the instructor has access to leading edge knowledge and information which is the highest qualification available for teaching the course.

There are no pre-requisites for this course.There are no pre-requisites for this course but basic understanding of risk management is recommended.
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 15-20 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.

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.

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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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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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