INTRODUCTION TO QUALITY MANAGEMENT FOR MEDICAL DEVICES AND ISO 13485

Learn about quality management and the requirements of ISO 13485 during this self-paced, interactive online course.

Quality Management for Medical Devices and ISO 13485 feature image
Online course

From € 299/ seat

See pricing plan

Course length approx. 10-27 hours
(19 CPD points)

Learn about quality management and the requirements of ISO 13485 during this self-paced, interactive online course.

Quality Management for Medical Devices and ISO 13485 feature image

ONLINE COURSE

Course length10-15 hours
Course fee
(per person)
from € 299
Purchase the course access for single user:
Purchase the course access for a group of users:

Select your course plan

ONLINE

YOU ARE HERE

€ 299​

Checkmark MDHQ  Average completion time​  10-27 hours

Checkmark MDHQ  Total video duration​ 5.5 hours

Checkmark MDHQ  CPD points 19 

Checkmark MDHQ  Number of quizzes​ 39

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

€ 399

Checkmark MDHQ  Average completion time​  10-27 hours

Checkmark MDHQ  Total video duration​ 5.5 hours

Checkmark MDHQ  CPD points 19 

Checkmark MDHQ  Number of quizzes​ 39

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ Ask the instructor

Checkmark MDHQ Lifetime access to the course and instructor

BLENDED

€ 899 ​

Checkmark MDHQ  Average completion time​  17-22 hours

Checkmark MDHQ  Total video duration​ 5.5 hours

Checkmark MDHQ  CPD points 26 

Checkmark MDHQ  Number of quizzes​ 34

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.
CPD points
This course is CPD-accredited. You will be able to claim CPD points and get a certificate with confirmation of CPD hours
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.
Digital 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.
€ 299
10-27 hours
5.5 hours
19 CPD points
39
6 months access

You're here

€ 399
10-27 hours
5.5 hours
19 CPD points
39
Lifetime access
€ 899
17-34 hours
5.5 hours
26 CPD points
39
Lifetime access
Contact us
Tailored training to meet your company’s needs

Course overview​

This online course is specifically tailored to make the requirements of the ISO 13485 as tangible and concrete as possible, so participants can confidently work in an organisation where ISO 13485 requirements apply. It introduces tools and methods on how to work successfully and efficiently within a quality management system.

Topics covered on the course include: the regulatory framework, the quality management system (QMS), documentation pitfalls, risk-based approach, management responsibility, product realization & traceability.

It is relevant for people working with QA related tasks in a medical device organisation (including authoring, reviewing and approving procedures) and those who are typically engaged in supporting QA related tasks such as CAPA, complaints, risk management, documentation and internal auditing.

The online course is made up of pre-recorded videos, quizzes, and a final exam. 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).

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Sis standard developer 2024 certification
Peter Sebelius instructor

Peter Sebelius (PMP) is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that has authored the latest versions of ISO 13485 and ISO 14971 standards.

He has vast ‘hands on’ experience too having developed, amongst other things, a mechanical chest compression and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.

Benefits for you

Checkmark MDHQ Understand the meaning of the requirements

Reading the ISO 13485 standard is easy (albeit not particularly entertaining), but understanding the meaning of the requirements and how to implement them in an effective way is much harder.

This course gives you the keys to unlock the meaning of the requirements and the ways you need to work operationally to meet the requirements.

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.

Course modules​​

  • Welcome
  • What you need to know
  • Set your course completion date
  • Pre-course assessment quiz
  • What is quality management and why it is important
  • The regulations and standard
  • What is a quality management system?
  • Shall or should
  • The structure of the QMS
  • Processes, policies and procedures
  • Maintaining the QMS
  • Which standard should you use?
  • Getting to know the ISO 13485
  • Risk management and ISO 13485
  • ISO 13485 stakeholders
  • Different types of audits
  • ISO 13485 internal audit requirements
  • Documents and records
  • Establish and implement a new document
  • Update and maintain a document
  • Control of records
  • Quality policy and objectives
  • Management review
  • Human resources
  • Responsibility and authority
  • Infrastructure and work environment
  • Selling a medical device
  • Design and development and projects
  • Design and development planning
  • Design and Development inputs
  • Design and development outputs
  • Verification and validation
  • Design and development transfer
  • Design and development review
  • Product documentation
  • Production (part 1)
  • Production (part 2)
  • Process validation
  • Measuring equipment and calibration
  • Nonconforming products
  • Design and development changes
  • Feedback and data analysis
  • CAPA
  • Course evaluation

NOTE – The course program structure 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 10-27 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.

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.

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 or Android 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 ISO 13485 and ISO 14971. 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 pre-requisites for this 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 earn CPD points and receive a certificate confirming your CPD hours.

Upon completing the course, you can claim 19 CPD hours (19 CPD points) for the online course, and 26 CPD hours for the blended course.

Your course certificate will display the earned CPD hours.

Reviews

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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