SAFETY FOR ELECTRICAL MEDICAL DEVICES AND IEC 60601
- Online course
- EU and US requirements
- Beginner - intermediate
- Last updated - Apr 2026
Learn how to be effective in medical device safety during this self paced, interactive online course.
Select your course plan
ONLINE
YOU ARE HERE
€ 449
Average completion time 9-25 hours
Total video duration 4.5 hours
CPD points 18
Number of quizzes 41
Final exam
Course certificate
Ask the instructor
6 months access to the course and instructor
Digital course companion
ONLINE LIFETIME
€ 549
Average completion time 9-25 hours
Total video duration 4.5 hours
CPD points 18
Number of quizzes 41
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Digital course companion
BLENDED
€ 1099
Average completion time 16-32 hours
Total video duration 4.5 hours
CPD points 25
Number of quizzes 41
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Digital course companion
Classroom sessions (2 * 3.5 hours)
Templates
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needsCourse overview
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 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.
It is made up of pre-recorded videos, quizzes, and a final exam. You will receive a course certificate upon successful completion of the course. There is also a downloadable course companion within the course.
If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access (conditions apply).
- This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training.
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.
Training effectiveness and record-keeping
Participants’ knowledge is assessed through pre-training quizzes and a final exam, enabling a true measure of the training’s effectiveness. Furthermore, we provide records, including the final exam score and course certificate, to satisfy ISO 13485 requirements, ensuring compliance and accountability.
Self-paced and bite-sized learning
Our interactive online courses offer the flexibility to learn at your own pace. The high-quality videos are designed in bite-sized segments, making it easier to grasp and retain information. This format provides a convenient alternative to traditional classroom courses accommodating different learning styles and preferences.
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.
Course modules
- 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
Frequently asked questions
All in all, the average time to complete the course is 9-25 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.
If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access to the course if you complete the final exam within 6 months of enrolment (conditions apply).
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 download a course companion within the online course. It contains a selection of key slides from the course and is in PDF format.
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 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.
Medical Device HQ is proud to be an accredited CPD provider, demonstrating our commitment to your continued professional development with high-quality training courses.
A CPD record showcases your professional growth, boosts confidence in your abilities, and can be presented to management for better career opportunities.
As a participant of a CPD certified course, you will receive a certificate awarding you CPD points following completion of the training.
Upon completing the course, you can claim 18CPD hours (18 CPD points) for the online course, and 25 CPD hours for the blended course.
Your course certificate will display the earned CPD hours. Read more.
Reviews
Abbvie
Cardiacbooster
AWCT
Heka-Dental A/S
UNEEG Medical
theDesignLink Limited
Lemberg Solutions
Group purchase
If you wish to purchase two or more seats on the same online course, click the ‘Buy multiple seats’ button below which will take you to the product page where you can simply enter the number of seats you require.
If you purchase three seats or more on the same online course at the same time, you will be added to the Professional Plan for free. This means a group account will be created for you that you can manage. You will be able to track the participant’s course progress from your group account and view quiz results.
It is the person that places the order who will be our single-point-of-contact and group leader for the group account. If you wish to change this to someone else later on, you can email us at support@medicaldevicehq.com.