€ 399 € 249
€ 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 €548 (€748 if bought separately).
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 are made up of pre-recorded videos, quizzes, and final exams. You will have access to the course bundle for 6 months from enrolment and 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.
The 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.
The 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.
You will have access to the 3-course bundle 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. 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. If you don’t have one, you can download it here for FREE.
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.
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.
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.
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 same bundles or more 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 email@example.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?