Register For Module 1 | Free-To-Attend
Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.
£716.00 – £1,356.00
Register for Module 1-Free (delivered online)
Gain a comprehensive understanding of the clinical data required for your device for CE marking under the MDR
Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.
Discount has been applied to the price above. VAT, if applicable, will be added. The full price for the 3-day classroom option is £1,995 and the 3-day live online option is £1,695.
The Medical Device Regulation (MDR) requires clinical evidence to demonstrate safety and clinical performance of a medical device. Clinical data obtained through clinical evaluations and investigations is required to CE mark a device. For most devices, clinical data must also be collected when the device is on the market to maintain patient safety. The regulations and guidance documents as well as applicable standards are detailed and require careful interpretation for different types of devices.
This interactive course focusses on all aspects of clinical evidence. You will examine the latest requirements and guidance available to ensure that you collect the right type of evidence and sufficient evidence for your medical device. You will learn about the clinical evaluation process, clinical investigations and post market clinical follow up studies and data collection. You will also cover specific clinical documents including the clinical investigation plan, clinical investigation report, clinical evaluation plan, clinical evaluation report, clinical development plan, summary of safety and clinical performance as well as post market clinical follow up plans.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver both online and classroom training courses. If you have any concerns about COVID-19 before registering on to the course, please read our COVID-19 commitment.
Find out when this course is running so you can plan your training.
3-Day Live Online Training
Register at the top of the page.
3-Day Hybrid Training
Get in touch to register for these dates. The largest price saving of 20% will be applied.
You can attend the days relevant to you:
When selecting 1 or 2-days, we will contact you confirming the day(s) you will be attending
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Or please summarise your objectives by following the link. Get in touch.
You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. If you cannot make the in-person course, you can attend online. The price is dependent on the option.
We recommend visiting our website to learn more. Click here to learn more about hybrid training at Educo Life Sciences.
* | • When selecting 1 or 2-days, we will contact you confirming the day(s) you will be attending |
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Kings College University (verified owner) –
One of the best medical device training courses I have attended. The course is very well structured and Janette is a very knowledgeable trainer with a wealth of experience in the field.
Reckitt Benckiser –
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Continence Care –
A well structured course following the MDR structure and contents of the topic of the course. Important for learning is the involvement and participation by participants in talks, considerations and cases – this too opened up as course moved forward thereby contributing to learning of second opinions and own insight and skill building – hands on, so to speak, being a valuable angle to the outcome value of course particpation.
Individual Booking –
As a complete beginner this was a very supportive environment in which to learn.
BAAT Medical (verified owner) –
I attended the full course and enjoyed the structured manner of teaching and the interactivity. We had a lot of interesting discussions during the course, which contributes a lot to my understanding and learning of the matter.
Individual Booking –
This course has been immensely valuable for me. It was well structured, engaging and had great content on the topic of “Gathering Clinical Evidence”. The delivery was excellent and the course was highly interactive. The trainer (Janette) was very accomodating and took time for all questions and queries. Her insights were really beneficial for me. Overall, this course has helped me gain great skills relevant to my job and I definitely recommend this to anyone seeking to gain new skills or expand their existing knowledge on this topic.
Individual Booking –
“The discussion room was very useful. I got useful insights that I took with me to share with my team.
The pre-learning analysis form- I was very skeptical at the start of the course, with regard to its use, for a person with my role- a multifaceted one. Having completed the course, I now have a different perception of it because I now see it as an aid in communicating with my team.
It is about seeing it as a conceptual tool that I can tailor to meet the needs of my audience and facilitate their learning or buy-in of a new idea. etc “
Inspira –
This course covers the clinical trial process and needs in a very clear fashion. The clinical evaluation plan and report was discussed a lot as this is the main change that will affect the development process of the device.
EMIS Health –
Great course, useful content, fantastic speaker
Sandoz (verified owner) –
I enjoyed this course so much. (It was face to face). The trainer was vibrant, super knowledgeable and keen on help and touch all topics the attendees were interested in. Special queries were allowed. Very informative course!
Alpha Omega (verified owner) –
n/a