QUICKSTART TO SOFTWARE FOR MEDICAL DEVICES AND IEC 62304

Get a basic understanding of medical device software development and IEC 62304 during this interactive online course.

Medical Device software course
Quickstart course

FREE

Course length 1-3 hours

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QUICKSTART

YOU ARE HERE

FREE ​

Checkmark MDHQ  Average completion time​  1-3 hours Checkmark MDHQ  Total video duration​ 32 minutes Checkmark MDHQ  Number of quizzes​ 5 Checkmark MDHQ  30 days access to the course Checkmark MDHQ  Digital course companion

ONLINE

€ 449​

Checkmark MDHQ  Average completion time​  9 - 25 hours

Checkmark MDHQ  Total video duration​ 6.5 hours

Checkmark MDHQ  CPD points 18 

Checkmark MDHQ  Number of quizzes​ 33

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​  9 - 25 hours

Checkmark MDHQ  Total video duration​ 6.5 hours

Checkmark MDHQ  CPD points 18

Checkmark MDHQ  Number of quizzes​ 33

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​  16-32 hours

Checkmark MDHQ  Total video duration​ 6.5 hours

Checkmark MDHQ  CPD points 25 

Checkmark MDHQ  Number of quizzes​ 33

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ  Lifetime access to the course and instructor

Checkmark MDHQ  Digital 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 quizzes 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.
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.
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.
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.
FREE
1-2 hours
32 minutes
/
5
30 days access
You're here
€ 449
9-25 hours
6.5 hours
18 CPD points
33
6 months access
€ 549
9-25 hours
6.5 hours
18 CPD points
33
Lifetime access
€ 1099
16-32 hours
6.5 hours
25 CPD points
33
Lifetime access
Contact us
Tailored training to meet your company’s needs

Course overview

This Quickstart course will give you a basic understanding of medical device software development and IEC 62304. It will help you decide if the full Introduction to Software for Medical Devices and IEC 62304 or Introduction to SaMD, IEC62304 and IEC82304-1 could benefit you in your career.

In this Quickstart course, you will learn the value of working with software architecture and gain an understanding of software risk management and configuration management.

We recommend this course to 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.

The course is made up of pre-recorded videos, quizzes, and a final exam. It also includes a downloadable digital course companion. You will have access to the course for 30 days.

Related courses

Learn how to be effective in medical device software development with IEC 62304 standard, learn its relationships with other standards, and apply it to your projects.

Course length 9-25 hours

€ 449

Learn how to plan and document software development with the course covering IEC 62304 and IEC 82304-1 regulatory requirements, cybersecurity management, cloud and AI.

Course length 10-29 hours

€ 499

Learn how to apply agile medical device software development process and practices in conformity with IEC 62304 and create a simple, efficient and compliant process.

Course length 6-16 hours

€ 799

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 Get a basic understanding of software for medical devices and IEC 62304

Get a basic understanding of software risk management, configuration management, and the value of working with IEC 62304.

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. There are quiz questions throughout with a final exam at the end to test learning.

Checkmark MDHQ Reference material

We understand the importance of retaining knowledge beyond the course duration. That’s why we provide a downloadable PDF file of the key course concepts which you can print off and take notes in.

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 1-3 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.

You will have access to the course for 30 days.

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). 

The course certificate is not available for this type of course. 

Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.

The course is personal, that means you buy a license for one person. If you have more than one person needing the course, please purchase another seat on the course.

There are no pre-requisites for this course.

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New Process validation for medical devices course!

Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.