This 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.


Course lengthapprox.
18-24 hours
Next classroom session
12 – 13 Oct 2021
1 PM – 5 PM 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 - Design Control Testimonial

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

This blended course is done in two parts: an online course with a final exam and a classroom session.

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 blended course comprises two parts: the online course and a live virtual classroom session.

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?

Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.

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.

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, we do. Use the contact form to request a quote for 3 or more participants.
How long will I have access to the course?
You will have access to the online course for six months.
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?
No, you cannot fail the final exam. However, it is 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 marker on 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 are the pre-requisites for this course?
There are no pre-requisites for this course.
Is the instructor accredited or certified to provide training?

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.

What payment methods will you accept?
After signing up on the course registration page, we will send you the invoice for the course.


It is a very high quality online course that I will recommend to my colleagues. The high density of the topic makes it ideal for a video course for me so I can see special topics more than once. It is evident that Claus Rømer Andersen knows what he is talking about from many years of practical experience with test and consultancy within electrical safety.
Good job!
Klaus Bang Andersen

Risk Manager, UNEEG Medical

This was well presented, comprehensive but always succinct and to the point; condensing some fairly complex concepts from EN60601-1 and providing plenty of practical take away ideas and methods to apply in device development.
Ben Bristow

Director, theDesignLink Limited

Would you prefer a course held on your premises?
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.

Register for a course

If you are already prepared to take a course, you can register for one of our upcoming blended courses. You’ll have 24 hours to cancel your reservation in case you can’t come.

Get more info about the course

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