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.

ONLINE COURSE

Course length10-15 hours
Course fee
(per person)
from € 449
Purchase the course access for single user:
Purchase the course access for a group of users:

Select your course plan

ONLINE

YOU ARE HERE

€ 449​

Checkmark MDHQ  Average completion time​  10-15 hours

Checkmark MDHQ  Total video duration​ 4.5 hours

Checkmark MDHQ  Number of quizzes​ 42

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ 6 months access to the course and instructor

ONLINE LIFETIME

€ 549

Checkmark MDHQ  Average completion time​  10-15 hours

Checkmark MDHQ  Total video duration​ 4.5 hours

Checkmark MDHQ  Number of quizzes​ 42

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ Ask the instructor

Checkmark MDHQ Lifetime access to the course and instructor

BLENDED

€ 1099 ​

Checkmark MDHQ  Average completion time​  17-22 hours

Checkmark MDHQ  Total video duration​ 4.5 hours

Checkmark MDHQ  Number of quizzes​ 42

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ  Lifetime access to the course and instructor

Checkmark MDHQ  Printed course companion

Checkmark MDHQ  Classroom sessions (2 * 3.5 hours)

Checkmark MDHQ  Templates

IN-HOUSE TRAINING​

CONTACT US​

Tailored training to meet your company's needs
Average completion time
The average course completion time varies based on prior knowledge and individual course goals. It includes video viewing, quizzes, and final exam.
Total video duration
This is the total recorded video duration for the whole course (excludes quizzes and exam). Participants often rewatch videos for better comprehension.
Number of quizzes
This is the total number of quiz questions in the course. They are spread throughout the course, typically at the end of each lesson. They can, for example, be multiple choices, true/false, or short written answers.
Course access
Lifetime access to the online course is granted upon completion of the course and final exam within six months from enrollment. Access continues as long as the course remains available on the website without significant changes.
Final exam
The final exam consists of 30-45 randomly selected quiz questions, taken once under timed conditions, for verification of training and course certificate issuance. No pass/fail, but the score is recorded in training record.
Course certificate
Upon completion of the final exam, two course certificates are issued: 1) A social media-friendly certificate that can be easily shared on LinkedIn. 2) A PDF course certificate, including the final exam score, suitable for your training records. When attending the blended course, a course certificate covering both the online course and the classroom session is also issued.
Ask the instructor
Enrolled learners can utilize the comment fields in each lesson to ask questions, which are answered by the course creator. Please note that the course creator provides responses to questions of a generic nature and they do not substitute regular consulting assignments.
Printed course companion
The personal printed course companion serves as a comprehensive summary of the online course, condensing the key concepts into concise bullet points accompanied by relevant images and helpful flowcharts.
Classroom sessions (2 * 3.5 h)
The classroom sessions, held over two half-days (3.5 hours each), provide a highly interactive environment for applying the theory learned during the online course. Guided by an expert instructor, there are real-life case scenarios to work through and plenty of time for discussions and questions. It's an opportunity to further enhance understanding and practical skills in a collaborative setting.
Templates
Our exclusive collection of time-saving templates are designed to enhance the online course experience. These templates provide practical knowledge and assist in implementing corresponding requirements to improve operations.
€ 449
10-15 hours
4.5 hours
42
6 months access

You're here

€ 549
10-15 hours
4.5 hours
42
Lifetime access
€ 1099
17-22 hours
4.5 hours
42
Lifetime access
Contact us​
Tailored training to meet your company’s needs

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 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.

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).

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 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.

Checkmark MDHQ 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.

medical device hq instructors - Claus Rømer

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 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

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.

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)

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.

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.

Testimonials

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.

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IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?

Oops, I actually wanted to buy seats for several people. Take me to the right place.

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Multiple seats

IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?

Oops, I actually wanted to buy seats for several people. Take me to the right place.

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