INTRODUCTION TO SAFETY FOR ELECTRICAL MEDICAL DEVICES AND IEC 60601
ONLINE COURSE
Learn how to be effective in medical device safety during this self paced, interactive online course.
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Course length
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10-15 hours
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Course fee
(per person)
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€ 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.
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
Become confident in how to develop a safe electrical medical device that meets type approval requirementsThe 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.
At the end of this course you will receive a course certificate which you can show auditors.
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. Auditors will look for evidence that you are competent in 60601-1.
Course programme
- 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
- 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 management 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
NOTE – Course programme is subject to change
Do you think you will learn more from a classroom course?
This course is also delivered as a blended course, where we combine the best of two worlds. You start with the online course, and then attend a live virtual 1-day classroom session with more in-depth information and practice.
Frequently asked questions
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.
Testimonials
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Group purchase
You can make a single seat purchase through the shopping cart on Medical Device HQ using a credit card or bank transfer. Please note that, when buying for yourself, the course access is linked to the email address, and the name you enter on checkout.
For a multiple seat purchase, click the button below which will take you to the product page where you can simply enter the number of seats you require.
With a group purchase, we can grant you (or another person you assign) group leader access which enables management of your group, including both adding and removing participants, and receiving progress reports and quiz reports.