INTRODUCTION TO SAFETY FOR ELECTRICAL MEDICAL DEVICES AND IEC 60601
ONLINE COURSELearn how to be effective in medical device safety at your own pace.
Take a look at our free short course on electrical medical device safety and 60601-1:
ONLINE COURSE |
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| Course length | 6-12 hours |
| Course fee (per person) |
€ 449
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Course description
This online course focuses on identifying and managing applicable safety related requirements throughout the design control process.
The course is practical and is suitable for anyone 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.
This online course covers an orientation of the entire 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.
By the end of the course you will know how to navigate the requriements of the standards effectively.
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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
Become confident in how to develop a safe electrical medical device that meets type approval requirements
The goal is that upon completion of this course, you should be able to understand how to navigate and manage the many requirements of the IEC 60601 series of standards. You should be able to integrate these requirements with the risk management process throughout the design control process.
Self-paced learning
You will have access to the course 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, where and when you want.
Increase your communication skills across functions
Learn how to cooperate with design team members from other functional areas (electrical, mechanical, software, RA, QA, etc.) and avoid the confusion and frustration that is common when working with IEC 60601 and type testing.
Course certificate to prove to regulatory bodies you know your stuff
Auditors will look for evidence that you are competent in 60601-1. At the end of this course you will receive a course certificate which you can show auditors.
Course programme
0 Base Course
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01. Introduction
- Welcome
- What you need to know
- Set your course completion date
- Pre-course assessment
- 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
02. Structure of the 60601 series of standards
- Introduction to the 60601 series of standards
- The general standard
- Relationship with ISO 14971 on risk management
03. 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)
04. 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
05. 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
06. 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
07. General requirements
- General requirements related to safety
- General requirements related to electromagnetic compatibility
- General requirements related to usability engineering
- Lifecycle managment of software
0 Base Course
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08. Internal verification
- Minimum requirements for inhouse testing
- Documentation: records, test plans and test reports
- Confidence in results and conclusions
09. 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
10. Product maintenance
- Change control
- Reasons for change
- Impact assessment and gap analysis
- Retesting
11. Summary and conclusion
- Summary and conclusion
12. Final exam
- Final exam
13. Course evaluation
- Course evaluation
14. End of course
- End of course
NOTE – Course programme is subject to change
Frequently asked questions
The course is not a webinar. This online course is made up of carefully scripted pre-recorded videos to maximize your learning. You can watch it as many times as you like, whenever and wherever you want. You can not download the course though, thus you will need to have an internet connection to take the course.
All in all, the average time to complete the course is 6-12 hours, but you can complete it in less time if you don’t repeat any of the lessons and have just one attempt at the quizzes. 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 shot.
You will have access to the course for six months.
What if I lose internet connection during the final exam?
You need to have contact with our servers for your results to register on the final exam. If your computer for some reason has a problem and does not allow you to send the result of the final exam to our servers, we recommend that you take a photo or a “print screen” of the screen with your results. E-mail this image to us and we will investigate if you have successfully completed the exam and therefore should receive a course certificate even though the result has not been registered, or if you have to do the final exam again.
Can I fail the final exam?
There is no pass/fail on the final exam (as long as you complete it within the time frame). Your result will be printed on the course certificate which means you can be really proud of your result if you get between 90% and 100% of the answers correct!
Where can I find my course certificate?
What payment methods will you accept?
You can pay using a credit card. You will receive a receipt of payment over email. Reach out to us on support@medicaldevicehq.com if you would like to be invoiced instead. Please note, if you would like to be invoiced, this will take longer and you will incur an invoicing fee.
Can I view the course on a mobile device?
Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.
Do you offer volume discounts?
If you buy more than 5 seats, you may want to consider our professional plan, which will give you discounted prices for seats on the course. Reach out to us using the contact form below and let us know how many seats you are interested in purchasing.
The course is personal, that means you buy a license for one person. It is also really inexpensive compared to any traditional course with the same scope. If you have more than one person needing the course, please purchase another seat on the course.
Is the instructor accredited or certified to give this training?
What are the pre-requisites for this course?