INTRODUCTION TO RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019

ONLINE COURSE

Learn how to be effective in risk management for medical devices during this self-paced, interactive online course.

ONLINE COURSE

Course length10-20 hours
Course fee
(per person)
from € 299
Purchase the course access for single user:
Purchase the course access for a group of users:

Select your course plan

ONLINE

YOU ARE HERE

€ 299​

Checkmark MDHQ  Average completion time​  10 - 20 hours

Checkmark MDHQ  Total video duration​ 3.5 hours

Checkmark MDHQ  Number of quizzes​ 26

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

€ 399 ​

Checkmark MDHQ  Average completion time​  10 - 20 hours

Checkmark MDHQ  Total video duration​ 3.5 hours

Checkmark MDHQ  Number of quizzes​ 26

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ Ask the instructor

Checkmark MDHQ Lifetime access to the course and instructor

BLENDED

€ 899 ​

Checkmark MDHQ  Average completion time​  17-27 hours

Checkmark MDHQ  Total video duration​ 3.5 hours

Checkmark MDHQ  Number of quizzes​ 26

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

ADVANCED

€ 499 ​

Checkmark MDHQ  Average completion time​  10 - 15 hours

Checkmark MDHQ  Total video duration​ 5.5 hours

Checkmark MDHQ  Number of quizzes​ 23

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ Ask the instructor

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.
Printed 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.

You're here

ONLINE
€ 299
10-20 hours
3.5 hours
26
6 months access
€ 399
10-20 hours
3.5 hours
26
Lifetime
€ 899
17-27 hours
3.5 hours
26
Lifetime
€ 499
10-15 hours
5.5 hours
23
Lifetime
Contact us
Tailored training to meet your company’s needs

Course description

This online course focuses on risk analysis, evaluation and risk control. It covers an orientation of the risk management process according to the EN ISO 14971:2019 version of the standard as well as the standard’s relation to tools and techniques such as FMEA and P-FMEA.

The course is practical and is suitable for anyone working with risk management, such as R&D and QA engineers, product and application specialists and clinical research specialists.

It is made up of pre-recorded videos, quizzes, and a final exam. 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).

Medical Device HQ is a member of the Swedish standardisation committee TK355 developing standards such as ISO 13485, ISO 14971 and IEC 62366-1. Peter Sebelius has partaken in authoring all of the above standards at an international level.

Sis standard developer 2024 certification

Benefits for you

Checkmark MDHQ Become confident in doing risk management work

The goal is that upon completion of this course, you should understand the overall process of risk management and how to create safe medical devices. You should also be able to participate in performing risk analysis, risk evaluation and risk control according to ISO 14971:2019. You should also be aware of different risk management tools and techniques, such as FMEA and P-FMEA.

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 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.

SPECIAL OFFER

RISK MANAGEMENT 3-COURSE BUNDLE FOR ONLY €648

INTRODUCTION TO RISK MANAGEMENT + ADVANCED RISK MANAGEMENT + HOW TO CREATE A RISK MANAGEMENT PLAN

Become highly proficient in risk management for medical devices with our 3-course online bundle
at the special price of €648 (€947 if bought separately). Additionally, you get upgraded to lifetime plans of the risk management courses for free.

Peter Sebelius instructor

Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that has authored the latest versions of ISO 13485 and ISO 14971 standards.

He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.

Course programme

  • Welcome
  • What you need to know
  • Set your course goal completion date
  • Pre-course assessment quiz
  • Why risk management and what it is? – Part 1
  • Why risk management and what it is? – Part 2
  • The regulatory background for risk management
  • The different versions of the standard
  • What is new in ISO 14971:2019
  • What is new in ISO 14971:2019/A11:2021
  • Getting to know the standard
  • The risk management process
  • Calling things by their right names
  • Management responsibility and training
  • Risk management planning and file
  • When and how to start
  • Hazard identification
  • Reasonably foreseeable sequence or combination of events
  • Hazardous situations and harm
  • How to work
  • Probability of occurrence of harm – Part 1
  • Probability of occurrence of harm – Part 2
  • Severity
  • Risk evaluation
  • Risk control option analysis – Part 1
  • Risk control option analysis – Part 2
  • Information for safety and disclosure of residual risk
  • Risk controls and verification
  • Estimating the residual risk and benefit
  • Residual risk in EU
  • Overall residual risk acceptability
  • Risk management review
  • Production and post-production activities
  • Usability engineering
  • Course evaluation

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 10-20 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.

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.
There are no pre-requisites for this course.

Testimonials

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?

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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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