Quality Management for Medical Devices: FDA QMSR, MDR and ISO 13485
- Online course
- EU and US requirements
- Beginner - intermediate
- Last updated - Sep 2026
Learn how quality management works in practice - and understand the requirements of FDA QMSR, the EU MDR, and ISO 13485 - in this self-paced, interactive online course.
- Understand how FDA QMSR, EU MDR, and ISO 13485 relate to one another - and what they mean in practice.
- See how quality management system requirements are typically implemented in medical device organisation.
- Learn how to apply the risk-based approach across processes - not just in risk management.
- Work confidently within a QMS - whether in QA, RA, R&D, production, or management.
| Course length | approx. 14-40 hours (28 CPD points) |
| Course length | approx. 14-40 hours |
Do you want this course on your internal LMS? Contact us
Select your course plan
ONLINE
YOU ARE HERE
€ 449 € 349
Average completion time 14-40 hours
Total video duration 7 hours
Number of quizzes 61
Final exam
Course certificate
Ask the instructor
6 months access to the course and instructor
ONLINE LIFETIME
€ 549 € 449
Average completion time 14-40 hours
Total video duration 7 hours
Number of quizzes 61
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
CPD points
Course overview
This online course is specifically tailored to make the requirements from the FDA QMSR, the EU MDR and ISO 13485 as tangible and concrete as possible, so participants can confidently work in an organisation where quality management system requirements apply. It introduces practical tools and methods for working successfully and efficiently within a quality management system.
Topics covered in the course include: the regulatory framework, the quality management system (QMS), documentation pitfalls, the risk-based approach, management responsibility, and product realisation & traceability.
This course serves as a solid starting point for QA professionals and others who are new to, or looking to strengthen their foundation in, quality management for medical devices.
It is suitable not only for those in dedicated QA roles, but also for professionals with a keen interest in quality management working in regulatory affairs, R&D, operations, production, and management who need a clear and practical understanding of how the system works in everyday practice.
The course is particularly 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).
Is this the right course for you?
Need a concise foundation for the wider team?
Introduction to Working in the Medical Device Industry covers the essential medtech and quality knowledge for R&D, production and other functions.
For internal auditors or deeper ISO 13485 understanding:
ISO 13485 Internal Auditor Training provides in-depth interpretation of the standard from an auditing perspective.
Course modules
- Welcome
- What you need to know
- Set your course completion date
- Pre-course assessment quiz
- The regulatory framework
- Standards
- Stakeholders
- What is a medical device
- What is quality management and ISO 13485
- Processes, policies and procedures
- Effective or efficient
- What is a QMS
- Shall or should
- The structure of the QMS
- Maintaining the QMS
- Risk management in ISO 13485
- Risk based approach – System
- Risk based approach – Prioritisation
- Efforts proportionate to risk
- Different types of audits
- How to behave during an audit
- ISO 13485 internal audit requirements
- Third-party audits
- Documents and records
- Establish and implement a new document – Part 1
- Establish and implement a new document – Part 2
- Update and maintain a document
- Control of records
- Quality policy and objectives
- Management review
- Human resources
- Responsibility and authority
- Infrastructure and work environment
- Design and development and projects
- Design planning
- Design and development inputs
- GSPR
- Design outputs
- Design verification and validation
- Design transfer
- Design review
- Product documentation
- Labelling and IFU
- Design changes
- Clinical evaluation and clinical investigation
- Medical device classification
- Market access routes for the EU
- EUDAMED
- Market access routes for the US
- Selling a medical device and claims – Part 1
- Selling a medical device and claims – Part 2
- Purchasing
- Production– Part 1
- Production – Part 2
- Process validation
- Measuring equipment and calibration
- Nonconforming products
- Device identification, tracking and traceability
- Feedback and data analysis
- CAPA – Part 1
- CAPA – Part 2
- Post-market surveillance (PMS)
- Complaints
- Vigilance – Part 1
- Vigilance – Part 2
- Corrections, removals and recalls
- Post-market clinical follow-up (PMCF)
- Management representative and PRRC
- Electronic records and signatures (FDA Part 11)
- Computer system validation
- Pre-final exam
- Final exam
- Course evaluation
NOTE – The course program structure is subject to change
Do you want this course on your internal LMS? Contact us
- Medical Device HQ is a member of the Swedish standardisation committee TK355 developing standards such as ISO 13485, ISO 14971 and IEC 62366-1. Peter Sebelius has partaken in authoring all of the above standards at an international level.
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
Understand the meaning of the requirements
Reading ISO 13485, the FDA QMSR, or the EU MDR may seem straightforward (albeit not particularly entertaining), but truly understanding the meaning of the requirements – and how to implement them in an effective and practical way – is much more challenging.
This course gives you the keys to unlock the intent behind the requirements and shows you how to translate them into operational ways of working that meet the expectations of ISO 13485, FDA QMSR, and the EU MDR – not just on paper, but in everyday practice.
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.
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 14-40 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.
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.