ADVANCED RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019

ONLINE COURSE

Become an expert in risk management for medical devices during this specialist, state-of-the-art, interactive online course.

It is a pre-requisite to have good knowledge and experience of risk management before starting the course.

We strongly recommend that you take the Introduction to Risk Management for Medical Devices online course before this course.

Advanced Risk Management for Medical Devices and ISO 14971:2019 online course feature image

ONLINE COURSE

Course length10-15 hours
Course fee
(per person)
€ 499
Purchase the course access for single user:
Purchase the course access for a group of users:

Select your course plan

ONLINE

€ 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

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  Digital course companion

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

ADVANCED

YOU ARE HERE

€ 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

 

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

€ 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 will provide you with a much deeper understanding of the concepts covered in the introductory risk management course.

It will deliver more information on the risk management process and procedure, and risk management planning. 

It will also provide an in-depth review of the different concepts of risk, what risks to include in the risk assessment, the risk control process, and how the required traceability can be achieved.

The course is aimed at people who are:

  • Leading risk management work;
  • Editing, reviewing and approving risk management procedures and templates;
  • Involved in risk management remediation efforts;
  • Auditors of risk management and QA professionals.

The online course is made up of pre-recorded videos, quizzes, and a final exam. If you complete the final exam within 6 months of enrolment, you will have lifetime access to the course (conditions apply). You will receive a course certificate upon successful completion of the course.

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 the expert

The goal is that upon completion of this course you should be able to evaluate the effectiveness of risk management processes, analyse conformity to regulatory requirements of risk management and recommend different approaches to risk management for different situations.

Checkmark MDHQ  Direct access to standards authors

Gain exclusive up to the minute information by learning from authors of the standards. 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. Our instructors are passionate about what they do, bringing their expertise and love for the subject into the learning experience to make it engaging and motivating.

Checkmark MDHQ Emphasis on implementation of requirements

While many courses focus solely on explaining the requirements, this course goes a step further by guiding you on how to actually implement them. By the end of the course you’ll not only understand the requirements but you will be equip with the practical knowledge and strategies for meeting them effectively.

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 completion date
  • Pre-course assessment
  • Creating a common ground
  • The system, process and procedure
  • The documentation structure – Part 1
  • The documentation structure – Part 2
  • The different concepts of risk – Part 1
  • The different concepts of risk – Part 2
  • Risk management planning – Part 1
  • Risk management planning – Part 2
  • Risk management planning – Part 3
  • The risk analysis process – Part 1
  • The risk analysis process – Part 2
  • The risk analysis process – Part 3
  • The risk analysis process – Part 4
  • What to include in the risk analysis – Part 1
  • What to include in the risk analysis – Part 2
  • What to include in the risk analysis – Part 3
  • The design, process and use – Part 1
  • The design, process and use – Part 2
  • The design, process and use – Part 3
  • Setting up a spreadsheet for hazard traceability
  • Challenges with Po
  • The most common mistakes in RM and the solution – Part 1
  • The most common mistakes in RM and the solution – Part 2
  • The most common mistakes in RM and the solution – Part 3
  • The risk control process
  • Inherent safety by design and protective measures – Part 1
  • Inherent safety by design and protective measures – Part 2
  • Information for safety and disclosure of residual risk – Part 1
  • Information for safety and disclosure of residual risk – Part 2
  • Information for safety and disclosure of residual risk – Part 3
  • Verification of effectiveness of risk controls
  • The alternative HTM and risk control
  • The risk management database
  • Using a spreadsheet as a risk management database
  • Using a SW tool for risk management
  • Pre-final exam
  • Course evaluation

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 10-15 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 complete the final exam within 6 months of enrolment, you will have lifetime access to the course (conditions apply). If you do not, your course access will expire after 6 months.

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.

It is a pre-requisite to have good knowledge and experience of risk management before starting the course.

We strongly recommend that you take the Introduction to Risk Management for Medical Devices online course before this course.

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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