This course is different to most courses on ISO 13485; it is more logical and focuses on how to practically implement the requirements of the standard, not just remember them.
You learn the theory first during the online course and then apply this knowledge during practical exercises in the virtual classroom sessions to gain hands-on experience.
€ 899/ seat
| Course length | approx. 17-34 hours (26 CPD points) |
| Next classroom sessions | 10-11 June 2025 1PM -4:30PM CET |
ONLINE
€ 299
Average completion time 10-27 hours
Total video duration 5 hours
CPD points 19
Number of quizzes 39
Final exam
Course certificate
Ask the instructor
6 months access to the course and instructor
Digital course companion
ONLINE LIFETIME
€ 399
Average completion time 10-27 hours
Total video duration 5 hours
CPD points 19
Number of quizzes 39
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Digital course companion
BLENDED
YOU ARE HERE
€ 899
Average completion time 17-34 hours
Total video duration 5 hours
CPD points 26
Number of quizzes 34
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 needs
This course consists of two parts:
1. The Introduction to Quality Management for Medical Devices and ISO 13485 online course
2. Two half-day live virtual classroom sessions led by an industry expert
First, you complete the popular introductory quality management for medical devices online course. Topics include among other things; regulatory framework, QMS, risk-based approach, and product realisation and traceability,.
You can start the online course immediately after enrolment and you must successfully complete the final exam prior to the classroom sessions. If you have already completed the online course, you can register for the classroom sessions only.
The unique, highly interactive live virtual classroom sessions are facilitated by Pontus Gedda, an expert in this field. During the sessions, you get to apply the theory you have learnt via case studies, workshops, and discussions. There is plenty of time for Q&As, and with a maximum of 8 people per classroom session, all participants have the opportunity to learn firsthand from an industry expert.
A downloadable pdf with text and slides, and time-saving templates are included in the blended course.
This course is ideal for individuals involved in QA-related tasks within medical device organisations, including the authoring, review and approval of procedures. It is also suitable for those who support QA tasks such as complaints, CAPA, risk management, internal auditing, and documentation.
Our blended learning courses combine the best of both worlds: online training and a live virtual classroom session(s) afterwards.
The online training allows for the flexibility in the way you learn, so that you can learn in a way which suits you best. You can access it whenever and wherever you want, and you can stop, start, and repeat the lessons and quizzes as often as you would like. To help maximise your learning, you can check your knowledge and understanding every step of the way by taking the assessment test beforehand, as well as the checkpoint quizzes that are found throughout the course. Ultimately, you will take a final exam at the end of the course.
The classroom session is highly interactive and focuses on applying the theory you have learnt during the online course with the guidance of the expert instructor. There are real-life case scenarios to work through and plenty of time for discussions and questions.
Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.
He has vast experience in the MDR and its implementation through hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.
He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.
Comprehending and translating the ISO 13485 requirements into effective operational procedures can be challenging. However, this course provides you with the tools necessary to unlock the meaning of the requirements and implement them efficiently.
By the end of the course you will be able to design and implement operational processes that align with ISO 13485 standards.
Gain exclusive up to the minute information by learning from authors of the standards.
Our courses are developed by members of the standardization committees involved at both national and international levels, ensuring you receive first-hand knowledge and insights.
Our instructors are passionate about what they do, bringing their expertise and love for the subject into the learning experience.
Participate in active learning by asking questions directly to the instructor, taking part in group workshops and discussions. This allows you to seek clarification, share insights, apply and transfer knowledge.
The online course comprises a mixture of pre-recorded videos, quizzes, and a final exam. It is self-paced and flexible so that you can start, stop, and repeat as much as you like. You will have lifetime access to the online course (conditions apply).
The Introduction to Quality Management for Medical Devices and ISO 13485 online course consists of 17 lessons which are outlined below.
You will attend these two half-day live virtual instructor-led classroom sessions via Zoom. The focus is on practicing the new skills, knowledge, and understanding learnt during the online course in a relaxed environment, with the guidance of an expert instructor. There are real-life case scenarios to work through, and plenty of time for discussions and questions.
The live virtual classes will delve into the practical implementation of tools and techniques to work efficiently within a quality management system.
The maximum number of people in a classroom session is 8.
Included is a downloadable course companion and the following time-saving templates:
The blended course consists of two parts: the online course, and two half-day live virtual classroom sessions.
The online course is made up of carefully scripted pre-recorded videos in order to maximise your learning. The live virtual classroom sessions are virtual face-to-face sessions where you will be interacting with the instructor and the other course participants via Zoom. You are required to be visible on video when taking the classroom sessions.
Yes, you can.
The time spent on the course varies greatly. If you are a beginner or have very high ambitions, you will typically spend more time on it. If you are already experienced in the field, you will probably finish it more quickly. The online course takes 10-27 hours to finish on average.
You do not have to watch the whole course at once. In fact, you can pause, resume, and replay as often as you like.
The two half-day live virtual classroom sessions, take approximately 7 hours in total.
You will be receiving a course certificate after completing the final exam. The course certificate is available when you log in to your account. Go to “My Courses”, and scroll down. You will find it under “Your Course Certificates”.
After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email.
If you wish to buy 3 or more seats, we invite you to reach out using the contact form to discuss discount options. Please note, if there are more than 5 people from your organisation wising to take the course, consider arranging an in-house course. The price will be lower, and the course can be customised to your needs.
If you complete the final exam within 6 months of enrolment, you will have lifetime access to the online course (conditions apply). If you do not, your course access will expire after 6 months.
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.
The maximum number of participants for the live virtual classroom session is 8.
There is no pass/fail score on the exam as such, but you are required to achieve 85% or more on the final exam to be allowed to attend the classroom session. The check-point quiz questions that are available during the online course will be a good model of what you will get on the final exam.
If you do not achieve 85%, the final exam can be reset for an administrative fee of 50 EUR, and you can take it again.
If you have already completed the online course and taken the final exam more than 3 weeks prior to the classroom session, and regardless of whether you have achieved >85%, we will reset the final exam for you for free.
You will need to retake the final exam by 3pm CET the day before the classroom session. This is because we insist all participants have the information fresh in their mind in order to maximise the learning experience in the live virtual classroom session.
The instructor has worked for a notified body for many years and has participated in NB-MED and expert groups. This ensures the instructor has access to leading edge knowledge and information which is the highest qualification available for teaching the course.
We offer a number of payment methods at checkout 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.
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 completion of this blended course, you are awarded 26 CPD points.
Your course certificate will display the exact number of CPD points. Read more.
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
Choose your course options below
IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?
Choose your course options below
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.
Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.