Risk management for medical devices and ISO 14971 online training
Take the free 30-minute introductory course, or the full version with course certificate for USD 299.
Risk Management for medical devices and ISO 14971
This is an interactive course that corresponds to a traditional one day course. You can pause, resume and repeat the course any time you like and you have 6 months to complete it. Every lesson has a quiz at the end that allows you to assess your learning. The goal of the course is that you should be able to work with risk management, it is a practical course with focus on how to do things, rather than just requirements or principles from the standard. The course is appropriate for anyone working with risk management, such as R&D Engineers, product specialists and the Quality Assurance department. It is also appropriate for people with a need to understand the requirements and principles of risk management, such as management, internal auditors, regulatory affairs and customer service.
1. Why risk management
This lesson covers what safety and risks are, why you should work with risk management and the regulatory background of risk management. It also includes an overview of important standards for risk management.
2. The General Requirements of Risk Management
The main topic of this lesson is the general requirements of risk management including management responsibility. You will also be introduced to the structure of the standard.
3. Risk Analysis
This lesson defines when to start risk analysis and appropriate pre-conditions. It also covers key definitions in risk management and the process to identify hazards and estimate risk. You will also be introduced to tools such as Fault-Tree Analysis (FTA), Failure Mode Effects Analysis (FMEA) and Process-FMEA.
4. Risk Evaluation
Learn how to evaluate risks and explain different areas in the risk evaluation matrix.
5. Risk Control
You will learn what types of risk control you should choose and in which order you are required to select them. The lesson introduces risk/benefit analysis, how you should verify risk controls and using risk controls from standards.
6. Overall Residual Risk Evaluation, Risk Management Report and Production and Post-production Information
You will learn to understand the concept of overall residual risk acceptability, know what should be included in the risk management report and the importance of continuing to update the risk management file.
7. Annex Z – The Content Deviations
In the recent EN ISO 14971:2012 version there are 7 content deviations that have to be addressed for the European market. This lesson critically assesses the impact of those content deviations and provide solutions on how the requirements can be met.
8. Final exam
You will only have one shot at the final exam. You should answer 60 randomly selected question in less than 45 minutes.
Is the course a live webinar?
The course is not a webinar, but a pre-recorded course with animations and audio. You can watch it as many times as you like, whenever you want and where ever you want. You can not download the course though, thus you will need to have internet connection to take the course.
How much time does the course take?
All in all, the average time to complete the course is 6-8 hours, but you can complete it in less time if you only go through it without repetitions and 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 in the final exam, where you will only have one shot.
For how long do I have access to the course?
You will have access to the course for at least three months, but we don’t automatically remove people from the course after that time, so for the most cases, you will have access for a longer time.
What if I lose internet connection during the Final exam?
You need to have contact with our servers to register your result on the final exam. In the unfortunate event you have a computer problem that does not allow you to send the result of the final exam to our servers for any reason, we recommend you to capture the screen with your result using “Print screen” or any other screen capture. You can even photograph the screen. E-mail this image to us and we will investigate if you can have 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), but your result will be printed on the course certificate, so if you have between 90% and 100% correct answers, you can be proud of your result.
Where can I find my course certificate?
The course certificate is available for download after completing the final exam. Log in to your account, go to the lessons overview and expand the final exam. From there you can download a pdf version of your course certificate.
What payment methods will you accept?
You can pay using Visa, Mastercard, Discover or American Express through paypal or use a paypal account. For Swedish and Danish customers we also offer the possibility to invoice the course. Contact us and say that you want to order the course and have it invoiced using the contact form.
Can I view the course on mobile?
Yes you can. The course is in HTML5 format which will play on any new iOS, Android or Windows phone.
Do you offer volume discounts?
If you buy more than 10 seats, we do. Use the contact form to request a quote for more than 10 participants.
Can a colleague and I take the course at the same time?
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.