ADVANCED RISK MANAGEMENT COURSE BUNDLE
INTRODUCTION TO RISK MANAGEMENT + ADVANCED RISK MANAGEMENT + HOW TO CREATE A RISK MANAGEMENT PLAN
This unique 3-course bundle will provide you with a much broader and more in-depth knowledge of risk management than any other training in the market for only €548! The basics on how to perform risk management is covered in the introductory course and the advanced course includes detailed perspectives on risk management up to expert level. It corresponds to at least 3 days of traditional classroom training in terms of scope and depth.
What's included in the bundle
Course price
€ 299
Course price
€ 399 € 249
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 €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.
Benefits for you
Become an expert in doing risk management work
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 source
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.
Flexible, self-paced learning with certification at the end to prove your competency
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.
INTRODUCTION TO RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019 (ONLINE)
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.
Course programme
- Welcome
- What you need to know
- Set your course goal completion date
- Pre-course assessment quiz
- Why risk management and what it is? – Part 1
- Why risk management and what it is? – Part 2
- ISO 14971 vs FMEA
- The regulatory background for risk management
- The different versions of the standard
- What is new in ISO 14971:2019
- What is new in ISO 14971:2019/A11:2021
- Getting to know the standard
- The risk management process
- Calling things by their right names
- Management responsibility and training
- Risk management planning and file
- When and how to start
- Hazard identification
- Reasonably foreseeable sequence or combination of events
- Hazardous situations and harm
- How to work
- Probability of occurrence of harm – Part 1
- Probability of occurrence of harm – Part 2
- Severity
- Risk evaluation
- Risk control option analysis – Part 1
- Risk control option analysis – Part 2
- Information for safety and disclosure of residual risk
- Risk controls and verification
- Estimating the residual risk and benefit
- Residual risk in EU
- Overall residual risk acceptability
- Risk management review
- Production and post-production activities
- Usability engineering
- Final Exam
- Course evaluation
ADVANCED RISK MANAGEMENT FOR MEDICAL DEVICES AND ISO 14971:2019
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.
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
- The risk analysis process – Part 4
- 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
- The design, process and use – Part 3
- Setting up a spreadsheet for hazard traceability
- Challenges with Po
- The most common mistakes in RM and the solution – Part 1
- The most common mistakes in RM and the solution – Part 2
- The most common mistakes in RM and the solution – Part 3
- The risk control process
- Inherent safety by design and protective measures – Part 1
- Inherent safety by design and protective measures – Part 2
- Information for safety and disclosure of residual risk – Part 1
- Information for safety and disclosure of residual risk – Part 2
- Information for safety and disclosure of residual risk – Part 3
- Verification of effectiveness of risk controls
- The alternative HTM and risk control
- The risk management database
- Using a spreadsheet as a risk management database
- Using a SW tool for risk management
- Final exam
- Course evaluation
HOW TO CREATE A MEDICAL DEVICE RISK MANAGEMENT PLAN
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.
Course programme
- Welcome
- Why and what is it?
- When to use it?
- How to create it?
- Final exam
- Course evaluation
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.
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.
Group purchase
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 support@medicaldevicehq.com.