The seminar helps you understand the MDR's regulatory requirements for creating clinical evaluation files. We introduce you to the clinical evaluation process and use exercises and case studies to show you how to review and assess clinical evaluation files in a targeted manner.
In this seminar, you will learn about the process and documentation of clinical evaluation at a meta-level.
Our expert will show you:
The trainer is highly competent and presented an informative and well-structured seminar from which I learned a lot. I liked the group work and the concrete examples best. All materials were excellent and very helpful. The organization was professional and optimal.
With your newly acquired knowledge, you can optimize your budget and resource planning for, e.g., development and post-market surveillance and perform risk estimation for your device approval or upcoming audits. In addition, you will receive valuable tips for implementing the actual data collection to save valuable time and money in this area.
The seminar combines short presentations, practical exercises using sample documents, group work, and an intensive exchange of experiences from past audits. You will gain the knowledge you need to act as a future reviewer (e.g., as CEO, project manager, or PRRC).
There is a voluntary online exam at the end of the seminar (duration: approx. 20 min). By passing this exam, you will receive a certificate proving your newly acquired knowledge and skills in addition to your attendance confirmation.
Phone
+49 7531 94500 20
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The seminar covers the following topics:
After the seminar, you will have all the relevant information to:
This seminar is designed for people who:
Participants can easily follow this seminar even without any special prior knowledge. Understanding your own medical devices is helpful.
After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.
An invoice will be sent to you within the next 48 hours, with a payment term of 14 days. If this payment term is not feasible for your company, please send a short e-mail to [email protected] to find a solution.
Three days before our online seminars and workshops, you will receive two e-mails: The first contains the final link to the seminar and the second contains the access data to a cloud folder in which you will find documents for preparation, exercises, and presentations.
If the seminar or workshop takes place in person, you will also receive the access link to your seminar documents three days before the date of the event. We will also provide documents in digital form for in-person events.
The seminar takes place either in person or online.
Our online/remote seminars and workshops are conducted via the video conferencing tool MS Teams. We recommend dialing in 20 minutes before the seminar begins so that any technical problems can be resolved in good time. If you have any questions or encounter any issues, our team is always available to help.
We also recommend that you arrive at the seminar room approximately 20 minutes before the start of the face-to-face events.
At the end of the seminar, you will receive a feedback link for evaluation. The following day, we will send you your certificate of attendance.
If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The documents provided also include an emergency number to help you in urgent cases.
Our general FAQ section answers further technical and organizational questions.
Dr. Nadine Jurrmann holds a doctorate in biology and worked for a medical device manufacturer for over six years. Her responsibilities at that time included conducting clinical evaluations and planning, implementing, and evaluating PMCF studies. Since 2019, she has been supporting our customers with strategic consulting on clinical evaluation and documentation of PMS and PMCF activities in accordance with MDR.
We are also happy to offer our seminars, courses, and workshops in-house. Depending on your needs, these can be held online or at your premises.
Please feel free to contact us.
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