Learn how to be effective in medical device safety during this self paced, interactive online course.

Online course
Course length
10-15 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.

It 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 requirements of the standards effectively.

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.

The course is made up of pre-recorded videos, quizzes, and a final exam. You will have access to the course for 6 months from enrolment and will receive a course certificate upon successful completion of the course.

Claus Rømer - Instructor

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

Checkmark MDHQ 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.

Checkmark MDHQ 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.

Checkmark MDHQ 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
  • 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 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 10-15 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.
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.
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!
The course certificate is available for download after completing the final exam. All you need to do is log in to your account, go to My Courses and scroll down. You will find it under Your Course Certificates.

We offer a number of payment methods including credit card, GooglePay, ApplePay, PayPal, wire transfer/invoice depending on the country you are buying from. If you cannot find your country on the list at checkout or you are not given wire transfer as a payment method, you can submit your order via our invoice order form

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

If you purchase five seats for the same online course at the same time, we will give you one extra seat for free on that same course (e.g. buy 5 get 6, buy 10 get 12, etc). The free seat is assigned manually after the order has been received.

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.
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 are no prerequisites for this course, though a general working knowledge of design control and risk management is expected.


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.

Still haven’t decided?
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