ONLINE
YOU ARE HERE
€ 399
Average completion time 9-26 hours
Total video duration 5.5 hours
CPD points 18
Number of quizzes 29
Final exam
Course certificate
Ask the instructor
Digital course companion
6 months access to the course
ONLINE LIFETIME
€ 499
Average completion time 9-26 hours
Total video duration 5.5 hours
CPD points 18
Number of quizzes 29
Final exam
Course certificate
Ask the instructor
Digital course companion
Lifetime access to the course and instructor
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
Templates
This online course focuses on the European regulation for medical devices, the MDR. It covers an orientation of the Medical Device Regulation according to (EU) 2017/745 as well as related guidance, like MDCG, and how to apply to a notified body for conformity assessment.
Topics covered include: how to work with the MDR, obligations of the manufacturer and other economic operators, UDI & EUDAMED, clinical evaluation and PMCF, post-market surveillance and vigilance.
It is suitable for anyone working with regulatory questions, such as RA and QA engineers, PRRC or management.
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).
NOTE – The course program structure is subject to change
Become confident in the MDRThe goal is that upon completion of this course, you should understand the overall structure and requirements of the MDR and where to find the answers to any stakeholders’ questions. You should also be confident in communicating with the regulators and other experts.
Self-paced and bite-sized learningOur 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.
Training effectiveness and record-keepingParticipants’ 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.
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.
All in all, the average time to complete the course is 9-26 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).
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.
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 worked for a notified body for many years and has participated in NB-MED and expert groups which is probably the highest qualification you can have in this area.
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 the course, you are awarded 18 CPD points.
Your course certificate will display the exact number of CPD points. Read more.
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.
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.
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.
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.