SAFETY FOR ELECTRICAL MEDICAL DEVICES AND IEC 60601-1
BLENDED COURSE: ONLINE COURSE + LIVE VIRTUAL CLASSROOM SESSIONDuring this innovative course, you will build an awareness of effective management of safety throughout the product lifecycle.
Develop and maintain electrical medical devices according to the IEC 60601-1 standard with more confidence after this blended course. You will gain an understanding for basic safety, and how to avoid the most common pitfalls. Learn the theory first during the online course, and then apply that theory during the live virtual classroom session(s).
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BLENDED COURSE |
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| Course length | approx. 17-22 hours |
| Next classroom session(s) |
25 – 26 Jan 2022
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| Course fee (per person) | € 1099 |
Course description
This course consists of two parts:
- The Introduction to Safety for Medical Devices and IEC 60601-1 online course
- A live virtual classroom session held by the course creator
First, you complete the popular introductory safety for medical devices online course. It covers topics such as proactive safety by design, identifying and managing requirements, internal verification, third party test and certification and product maintenance.
You can start the online course immediately and have access to it for 6 months, but you must successfully complete the final exam prior to the classroom session. If you have already completed the online course, you can register for the classroom session only.
The unique, highly interactive live virtual classroom session is facilitated by Claus Rømer Andersen, who is an expert in this field. During the session, you get to apply the theory you have learnt via case studies, workshops, and discussions. There is plenty of time for Q&As, and with a maximum of 8 people per classroom session, all participants have the opportunity to learn firsthand from an industry expert.
A printed course companion is included, as well as time-saving templates on how to implement design control effectively and efficiently.
We recommend this course to those who are working with development or maintenance of an electrical medical device, such as R&D engineers, product specialists, risk management specialists, regulatory specialists and the Quality Assurance department.
Want to know more about our blended courses? Watch the video below.
The online training allows for the flexibility in the way you learn, so that you can learn in a way which suits you best. You can access it whenever and wherever you want, and you can stop, start, and repeat the lessons and quizzes as often as you would like. To help maximise your learning, you can check your knowledge and understanding every step of the way by taking the assessment test beforehand, as well as the checkpoint quizzes that are found throughout the course. Ultimately, you will take a final exam at the end of the course.
The classroom session is highly interactive and focuses on applying the theory you have learnt during the online course with the guidance of the expert instructor. There are real-life case scenarios to work through and plenty of time for discussions and questions.
Claus Rømer Andersen is an accomplished trainer, consultant and facilitator in the medical device industry. With a background in electrical engineering, he has worked with regulatory navigation, approval management, device testing throughout his whole career.
He is recognized as having a pragmatic and solution oriented approach to helping development teams focus on relevant issues throughout the entire product life-cycle.
Benefits for you
Understand why and how to work with safety for electrical medical devices
Safety for electrical medical devices can be made incredibly abstract if there is too much focus on the intangible requirements instead of how to actually do the work. This course focuses on identifying and managing applicable safety related requirements throughout the design control process.
Get the big picture
You will get a clear overview of safety for electrical medical devices, which covers all aspects of the IEC 60601 series of standards, how to identify and manage product-specific requirements and how this process is integrated with the design control and risk management processes.
Blended learning combines the best of both worlds
You get to learn the theory at your own pace, during the online course, before applying the theory to practice with the guidance of an industry expert. You can get started on the online course right after registration and invoicing.
Course certificate
Auditors may look for evidence that you are competent in safety for electrical medical devices. You will receive a course certificate after the successful completion of the course, which you can show the auditors if they ask.
Course structure
Online course
The online course comprises a mixture of pre-recorded videos, quizzes, and a final exam. You have the access to the online course for 6 months. It is self-paced and flexible in that you can start, stop, and repeat as much as you like. When you have finished the online course, you will be taking the final exam.
The Introduction to Safety for Electrical Medical Devices and IEC 60601-1 online course consists of 14 lessons which are outlined below.
0. Opening
Lesson 1. Introduction
- Welcome
- What you need to know
- Set you course completion date
- Pre-course asssessment quiz
- Why consider general safety – and what is it?
- Which types of medical devices are in scope of IEC 60601
- When to address IEC 60601 in the design process
- The changing world of regulatory requirements and standards
Lesson 2. Structure of the 60601 series of standards
- Introduction to the 60601 series of standards
- The general standard
- Relationship with ISO 14971 on risk management
Lesson 3. Key terminology
- Basic safety and essential performance
- How to determine which parts are applied parts
- Identifying patient connections
- How to categorise applies parts
- Explanation of means of protection (MOP)
Lesson 4. Proactive safety by design
- Where most manufacturers go wrong
- How to integrate with the risk management process – Part 1
- How to integrate with the risk management process – Part 2
- How to manage requirements
- Effective identification of applicable risks and requirements
- Iterative concept development, coupled with safety by design
- Define your documentation architecture – Risk management file records related to safety
Lesson 5. Identifying and managing requirements
- Hazards, risks, test method, test level acceptance criteria
- Systematic review and translation of the standards
- Development of the insulation diagram
- Identifying and managing critical components
- Classifications according to the standard
- Identifying insulation requirements – Part 1
- Identifying insulation requirements – Part 2
- Defining test plans and protocols
Lesson 6. Design and development
- The objective: Safe in NC and SFC
- Critical components vs redundant design
- Power supplies and batteries
- Enclosure material and design (fire encl., IP)
- Indicator lights
Lesson 7. General requirements
- General requirements related to safety
- General requirements related to electromagnetic compatibility
- General requirements related to usability engineering
- Lifecycle managment of software
0. Opening
Lesson 8. Internal verification
- Minimum requirements for inhouse testing
- Documentation: records, test plans and test reports
- Confidence in results and conclusions
Lesson 9. Third party test and certification
- On third party testing, accreditation and ‘CB Scheme’
- Selection of laboratory
- Request for quote
- Preparing the documentation
- Pre-testing
- Preparing for test
- Managing the test process
- Evaluating the test results, reports and certificates
Lesson 10. Product maintenance
- Change control
- Reasons for change
- Impact assessment and gap analysis
- Retesting
Lesson 11. Summary and conclusion
- Summary and conclusion
Lesson 12. Final Exam
- Final Exam
Lesson 13. Course Evaluation
- Course evaluation
Lesson 14. Classroom session info, case study & more!
- Learn more in a live virtual class
- The live virtual class product
- Get your questions answered on the live virtual class
Classroom session(s)
You will attend this 1-day or 2 half-day live virtual instructor-led classroom session(s) via Zoom. The focus is on practicing the new skills, knowledge, and understanding learnt during the online course, in a relaxed environment, with the guidance of an expert instructor. There are real-life case scenarios to work through, and plenty of time for discussions and questions.
The live virtual class will cover all aspects of the IEC 60601 series of standards, how to identify and manage product specific requirements and how this process is integrated with the design control and risk management processes.
The maximum number of people in a classroom session is 8.
Included is a printed course companion and the following time-saving templates:
- IEC 60601-1 ed. checklist
- Insulation diagram
- Critical component checklist
- Insulation barrier table
- Test protocol
- Test plan
- Essential performance specification
Frequently asked questions
Is the course a live webinar?
The blended course consists of two parts: the online course, and a live virtual classroom session.
The online course is made up of carefully scripted pre-recorded videos in order to maximise your learning. The live virtual classroom session is a virtual face-to-face 1-day session where you will be interacting with the instructor and the other course participants via Zoom. You are required to be visible on video when taking the classroom session.
Can I view the online course on a mobile device?
Yes, you can.
How long does it take to complete the course?
The time spent on the course varies greatly. If you are a beginner or have very high ambitions, you will typically spend more time on it. If you are already experienced in the field, you will probably finish it more quickly. The online course takes 10-15 hours to finish on average.
You do not have to watch the whole course at once. In fact, you can pause, resume, and replay as often as you like. The live virtual classroom is a 1-day session, or 2 half-days, and lasts approximately for 7 hours.
Where can I find my course certificate?
You will be receiving a course certificate after completing the final exam. The course certificate is available when you log in to your account. Go to “My Courses”, and scroll down. You will find it under “Your Course Certificates”.
After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email.
Do you offer volume discounts?
If you buy more 3 or more seats for one person, we do. Use the contact form to request a quote for 3 or more participants. Please note, if there are more than 5 people from your organisation that should take the course, consider arranging an in-house course. The price will be lower, and the course can be customised to your needs.
How long will I have access to the course?
You will have access to the online course for six months.
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What is the maximum number of participants in the live virtual classroom?
The maximum number of participants for the live virtual classroom session is 8.
Can I fail the final exam?
There is no pass/fail score on the exam as such, but you are required to achieve 85% or more on the final exam to be allowed to attend the classroom session. The check-point quiz questions that are available during the online course will be a good model of what you will get on the final exam.
If you do not achieve 85%, the final exam can be reset for an administrative fee of 50 EUR, and you can take it again.
What if I have already completed the online course and taken the final exam?
If you have already completed the online course and taken the final exam more than 3 weeks prior to the classroom session, and regardless of whether you have achieved >85%, we will reset the final exam for you for free.
You will need to retake the final exam by 3pm CET the day before the classroom session. This is because we insist all participants have the information fresh in their mind in order to maximise the learning experience in the live virtual classroom session.
What are the pre-requisites for this course?
There are no pre-requisites for this course.
Is the instructor accredited or certified to give this training?
There is no certification or accreditation for safety for medical devices or IEC 60601, however the instructor has conducted training in the field for many years and continuously participates in authoring standards such as the IEC 60601-1 and the collateral standards.
He is an accomplished trainer, consultant, and facilitator in the medical device industry. With a background in electrical engineering, he has worked with regulatory navigation, approval management, device testing throughout his whole career. This ensures the instructor has access to leading-edge knowledge and information, which is the highest qualification available for teaching the course.
What payment methods do you accept?
The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, then you can select Direct bank transfer at the very end of the checkout process. You will receive an invoice instead, and you can pay by bank transfer.
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