ADVANCED RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019
- Online course
- EU and US requirements
- Intermediate - advanced
- Last updated - Feb 2026
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 Risk Management for Medical Devices online course before this course.
Select your course plan
ONLINE
€ 399
Average completion time 6-16 hours
Total video duration 4 hours
CPD points 12
Number of quizzes 23
Final exam
Digital course companion
Course certificate
Ask the instructor
ONLINE LIFETIME
€ 499
Average completion time 6-16 hours
Total video duration 4 hours
CPD points 12
Number of quizzes 23
Final exam
Digital course companion
Course certificate
Ask the instructor
Lifetime access to the course and instructor
BLENDED
€ 999
Average completion time 13-23 hours
Total video duration 4 hours
CPD points 19
Number of quizzes 23
Final exam
Digital course companion
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Classroom sessions (2 * 3.5 hours)
Templates
ADVANCED
YOU ARE HERE
€ 499
Average completion time 9-25 hours
Total video duration 6 hours
CPD points 16
Number of quizzes 25
Final exam
Digital course companion
Course certificate
Ask the instructor
Lifetime access to the course and instructor
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
SPECIAL OFFER
RISK MANAGEMENT 3-COURSE BUNDLE FOR ONLY €748
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 €748 (€1047 if bought separately). Additionally, you get upgraded to lifetime plans of the risk management courses for free.
Course overview
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.
- This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training.
- 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.
Benefits for you
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.
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.
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.
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 modules
- Download your course companion – part 1
- 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
- Download your course companion – part 2
- 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
- Download your course companion – part 3
- Harm, injury and the medical device – Part 1
- Harm, injury and the medical device – Part 2
- Generic or specific harms
- Injury dynamics framework
- 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
- Final exam
- Course evaluation
NOTE – The course program structure is subject to change
Frequently asked questions
All in all, the average time to complete the course is 8-22 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.
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 Risk Management for Medical Devices online course before this course.
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 receive a certificate awarding you CPD points following completion of the training.
Upon completion of the course, you are awarded 16 CPD points for the online course and 19 CPD points for the blended course.
Your course certificate will display the exact number of CPD points. Read more.
Reviews
Cornerstone Robotics
Galderma
Novostia SA
RD - QT Medical Inc
AWCD
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.