ADVANCED RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019
ONLINE COURSE - COMING SOON
COMING SOON
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.
Would you like to get this course for FREE?
We are currently looking for people to validate this course in exchange for free course enrolment.
Please apply to be a validator by clicking on the button which will take you to an application form.
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 course is made up of pre-recorded videos, quizzes, and a final exam. You will have access to the course for 6 months from enrolment and will receive a course certificate upon successful completion of the course
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Peter Sebelius (PMP) 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 too having developed, amongst other things, a mechanical chest compression 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.
Benefits for you
Become the expert
Become the expertThe 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.
Get information from the source
The instructor is a member of JWG3 that authors the ISO 14971 standard. This means you will be getting first hand information. And at the end of the course you will receive a certificate that proves to regulatory bodies that you are competent in risk management.
Self-paced learning
You will have access to the course for 6 months. The great thing about our online courses is that you can stop, repeat and resume as many times as you like during this time! This provides you with the flexibility to learn how and when you want.
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
- 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
- Challenges with Po
- The most common mistake in RM and the solution – Part 1
- The most common mistake in RM and the solution – Part 2
- The most common mistake in RM and the solution – Part 3
- The risk control process
- Inherent safety by design and protective measures
- Information for safety and disclosure of residual risk – Part 1
- Information for safety and disclosure of residual risk – Part 2
- Verification of effectiveness of risk controls
- The alternative HTM and risk control
- Risk management as a database
- How to document risk assessment and risk control – Part 1
- How to document risk assessment and risk control – Part 2
- Should you have a software tool for risk management?
- 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 10-15 hours. 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 attempt at taking it.
The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, then you can select Direct bank transfer at the very end of the checkout process. You will receive an invoice instead, and you can pay by bank transfer.
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.
You are required to have good knowledge and experience of risk management before starting this course. We also strongly recommend that you take the Introduction to Risk Management for Medical Devices and ISO 14971:2019 online course before this course.