SAFETY FOR ELECTRICAL MEDICAL DEVICES AND IEC 60601-1
BLENDED COURSE: ONLINE COURSE + LIVE VIRTUAL CLASSROOM SESSIONS
During 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 two live virtual classroom sessions.
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Course length
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approx.
17-22 hours |
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Next classroom sessions
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13-14 Sept 2023
1PM-4:30PM CET |
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Course fee
(per person) |
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€ 1099
Cancellation policy |
Course description
This course consists of two parts:
1. The Introduction to Safety for Medical Devices and IEC 60601-1 online course
2. Two half-day live virtual classroom sessions 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 sessions. If you have already completed the online course, you can register for the classroom sessions only.
The unique, highly interactive live virtual classroom sessions are facilitated by Claus Rømer Andersen, who is an expert in this field. During the sessions, 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 first-hand 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.
Our blended learning courses combine the best of both worlds: online training and two half-day live virtual classroom sessions afterwards.
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 sessions are 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
- Get the big picture
- Blended learning combines the best of both worlds
- Course certificate
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.
- 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
- Introduction to the 60601 series of standards
- The general standard
- Relationship with ISO 14971 on risk management
- 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)
- 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
- 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
- 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
- General requirements related to safety
- General requirements related to electromagnetic compatibility
- General requirements related to usability engineering
- Lifecycle managment of software
- Minimum requirements for inhouse testing
- Documentation: records, test plans and test reports
- Confidence in results and conclusions
- 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
- Change control
- Reasons for change
- Impact assessment and gap analysis
- Retesting
- Summary and conclusion
- Final Exam
- Course evaluation
- 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 these two half-day live virtual instructor-led classroom sessions 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 classes 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
The blended course consists of two parts: the online course, and two half-day live virtual classroom sessions.
The online course is made up of carefully scripted pre-recorded videos in order to maximise your learning. The live virtual classroom sessions are virtual face-to-face sessions 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 sessions.
Yes, you can.
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 two half-day live virtual classroom sessions take approximately 7 hours in total.
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.
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 sessions. 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.
If you have already completed the online course and taken the final exam more than 3 weeks prior to the classroom sessions, 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 first 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 sessions.
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.
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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