ADVANCED RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019
ONLINE COURSE - COMING SOONCOMING SOON
Become an expert in risk management for medical devices during this specialist, state-of-the-art, interactive online course.
A pre-requisite for this course is that you have taken the Introduction to Risk Management for Medical Devices online course.
ONLINE COURSE |
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| Course length | 5-10 hours |
| Course fee (per person) |
€ 449
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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 deeper understanding of the concepts covered in the introductory course. It will provide more information on the risk management process and procedure, risk management planning, overall residual risk evaluation and benefit-risk analysis. The course also includes additional risk management tools and techniques and covers their strengths and weaknesses.
The course aimed at people who are leading risk management work, auditors of risk management and QA professionals. This also includes project managers running projects with little or no support from risk management specialists.
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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 is revising the 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
The goal is that upon completion of this course you should be able to analyse the overall process of risk management and how to create safe medical devices. You should also be able to contribute to authoring risk management procedures and audit them, and create documentation needed before and after risk analysis, risk evaluation and risk controls.
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
0 Base Course
Lesson 1. Introduction
– To be determined
Lesson 2. The risk management process
Lesson 3. Quality requirements
- To be determined
Lesson 4: Audits and inspections
- To be determined
Lesson 5. Managing risk management work
- To be determined
Lesson 6. Leading the risk management work
- To be determined
Lesson 7. Safety principles and risk controls
- To be determined
0 Base Course
Lesson 8. Evaluating the overall residual risk acceptability
- To be determined
Lesson 9. Risk management review
- To be determined
Lesson 10. Production and post-production activities
- To be determined
Lesson 11. Risk in other standards and risk based approach
- To be determined
Lesson 12. Risk management according to the MDR
- To be determined
Lesson 13. Final exam
Lesson 14. 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 5-10 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 shot.
You will have access to the course for six months.
What if I lose internet connection during the final exam?
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.
Can I fail the final exam?
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!
Where can I find my course certificate?
What payment methods will you accept?
You can pay using a credit card. You will receive a receipt of payment over email. You can select to pay by invoice instead of credit card at the end of the check-out process. Please note, if you would like to be invoiced, this will take longer and you may incur an invoicing fee.
Can I view the course on a mobile device?
Yes, you can. The course is in HTML5 format which will play on any new iOS or Android devices.
Do you offer volume discounts?
If you buy more than 5 seats, you may want to consider group purchase, which will give you discounted prices for seats on the course. Reach out to us using the contact form below and let us know how many seats you are interested in purchasing.
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.
Is the instructor accredited or certified to give this training?
There is no certification or accreditation for risk management, however the instructor has conducted training in the field for many years and continuously participate in authoring the ISO 14971 standard, which is the highest qualification you can have in this area.
What are the pre-requisites for this course?
A pre-requisite for this course is that you have taken the Introduction to Risk Management for Medical Devices and ISO 14971:2019 online course.
