SAFETY FOR ELECTRICAL MEDICAL DEVICES AND IEC 60601-1
ONLINE + LIVE VIRTUAL CLASSROOM TRAINING - BLENDED COURSEThis is a blended (online + live virtual classroom session) course designed to teach you how to identify and manage applicable safety related requirements throughout the design control process according to IEC 60601-1.
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BLENDED COURSE |
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| Course length | approx. 18-24 hours |
| Next classroom session |
20 April 2021 9:00-4:30 CET |
| Course fee (per person) | € 1099 |
Course description
This blended (online + live virtual) course focuses on identifying and managing applicable safety related requirements throughout the design control process. Topics covered include: proactive safety by design, identifying and managing requirements, internal verification, third party test and certification and product maintenance.
The course 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.
It is intended to be practical and 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.
What is a blended course?
Our blended learning courses combine the best of two worlds: online training with live virtual classroom sessions. You get to learn the theory first at your own pace, during the online course, before applying theory in practice with the guidance of the expert instructor.
The online training provides flexibility in how you learn so you can learn in a way that 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 like. To help maximise your learning we assess your knowledge and understanding at the start and throughout the online training, culminating with a final exam at the end.
The classroom session is highly interactive and focuses on applying the theory in practice 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
Become confident in doing safety for medical devices work
The course is practical. You will be working on realistic tasks relating to the safety for medical devices according to IEC 60601-1, both in groups and individually during the live virtual classroom session. 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 and integrate them with the risk management process throughout the design control process.
Templates to give you a head start
The course includes useful templates for safety for medical devices. You can customize or learn from them and use in your company. This can give you a head start on software development if your company is not up and running already in this field.
Start right away
You can get started on the online course after registration and invoicing.
Course certification
Auditors may look for training on the IEC 60601. You will have a nice-looking course certificate to present if you get asked the question during an audit. Avoid the discussion with the auditor of whether you know IEC 60601 or not.
Get information from the source
The instructor is an expert member of the project authoring the IEC 60601-1 standard and the collateral standards. If you are looking for a course about safety for medical devices, make sure you choose a course where the instructor has first-hand information.
Course programme
Online course structure
0. Opening
01. 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
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
08. Internal verification
- Minimum requirements for inhouse testing
- Documentation: records, test plans and test reports
- Confidence in results and conclusions
0. Opening
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. Pre-classroom survey
- Pre-classroom survey
13. Final Exam
- Final Exam
14. Course Evaluation
- Course evaluation
15. End of course
- End of course
Classroom session
1-day or 2-half days live virtual instructor-led classroom sessions working on case studies & real-life scenarios.
Frequently asked questions
Is the course a live webinar?
The online course is made up of carefully scripted pre-recorded videos to maximize 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 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?
How long does it take to complete the course?
All in all, the average time to complete the blended course is 18-24 hours. The online course takes approximately 10-14 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 live virtual classroom is a 1-day session and lasts approximately 8 hours.
After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email.
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.
There is no certification or accreditation for 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. This ensures the instructor has access to leading edge knowledge and information which is the highest qualification available for teaching the course.There is no certification or accreditation for software development, however the instructor is an expert member of the project authoring the standard. If you are looking for a course about software development, make sure you choose a course where the instructor has first-hand information.
Testimonials
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