Course price
€ 499 € 399
Course price
€ 499 € 349
Course price
€ 49 FREE
To help you build your skills and experience whilst gaining maximum value for money we have created the 3-course bundle offer for the special price of €748 (€1047 if bought separately). As part of the bundle package you get upgraded to life-time plans of the risk management courses for free.
We strongly recommend you take the introductory risk management course first as it is pre-requisite to have good knowledge and experience of risk management and ISO 14971 prior to taking the advanced course.
The bundle 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 three courses consist of pre-recorded videos, quizzes, and a final exam. You will receive a course certificate for each course upon completion.
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.
Become an expert in doing risk management workThe goal is that upon completion of this 3 – course bundle you should be able to not only work with risk management practically, but also 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 sourceThe instructor is a member of JWG3 that authors the ISO 14971 standard. This means you will be getting first-hand information from a truly qualified expert.
Flexible, self-paced learning with certification at the end to prove your competencyThe great thing about our online courses is that you can stop, repeat and resume as many times as you like! This provides you with the flexibility to learn how and when you want. You will receive a certificate at the end of each course which you can show auditors to prove your competency.
This online course focuses on risk analysis, evaluation and risk control. It covers an orientation of the risk management process according to the EN ISO 14971:2019 version of the standard as well as the standard’s relation to tools and techniques such as FMEA and P-FMEA.
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.
This ‘How to’ course focuses on the practical creation of a medical device risk management plan that meets the requirements of ISO 14971:2019, MDR and QSR. In order to get the most out of this course we suggest you have the Medical Device HQ risk management plan template with you. Template is included with the course.
All in all, the average time to complete the 3-course bundle is 15-40 hours. We recommend you take one course at a time.
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.
On the condition that you complete the final exam for both the Advanced and Introductory Risk Management online courses within 6 months of enrolment, you will have lifetime access to the courses (conditions apply).
The course certificates are 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 them under Your Course Certificates.
We offer a number of payment methods via checkout 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.
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 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.
There are no pre-requisites for this 3-course bundle.
If you wish to purchase two or more licenses of the same bundle, click the ‘Buy multiple bundles’ button below which will take you to the product page where you can simply enter the number of bundles you require.
If you purchase three or more of the same bundle 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.
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
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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.
Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.