This practical seminar helps you, as an author, understand the regulatory requirements of the MDR, the relevant MDCG documents, and MEDDEV 2.7/1 rev.4 for clinical evaluation.
Based on this, you will learn how to plan your clinical evaluation optimally, carry it out efficiently, and document it compliantly.
First, you will gain a detailed overview of the complex requirements for clinical evaluation and learn about the interactions with other regulatory processes.
We will then show you how to:
The seminar was very well structured. The mix of lectures and group work in small groups or as a whole was very good and helped to better understand and consolidate what we had learned. I was very impressed by the knowledge of the different backgrounds of the participants and their requirements, and this was repeatedly incorporated into the seminar. It is probably the best seminar I have attended so far.
Our expert team provides you with strategic approaches and proven procedures to optimally plan your clinical evaluation, carry it out efficiently, and document it in the clinical evaluation file in accordance with MDR. We familiarize you with industry best practices. In doing so, we follow regulatory standards and the latest feedback from notified bodies.
The seminar is characterized by its practical relevance. In addition to relevant case studies, you will deepen your knowledge through numerous practical exercises on creating a clinical evaluation file. You will gain complete confidence in writing your own clinical evaluation as a (future) author.
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.
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+49 7531 94500 20
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The seminar covers the following topics:
After the seminar, you will:
This seminar is designed for:
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.
Lea Wettlaufer supports our customers in conducting clinical evaluations and post-market surveillance of medical devices. Her focus is on defining clinical strategies in accordance with MDR requirements. As a certified clinical research associate, she is familiar with the interaction between clinical investigations and clinical evaluation. Her responsibilities include supporting post-market activities, particularly clinical follow-up. As a lecturer for seminars, workshops, and our Medical Device Days, she knows our customers' challenges in clinical evaluation and PMS/PMCF.
Dr. Anja Kuhnert spent many years as a quality and regulatory affairs manager for various medical device manufacturers, where she gained first-hand experience of the concerns of start-ups and small companies. At the Johner Institute, she now supports our customers in defining the clinical evaluation strategy, creating compliant clinical evaluations, and meeting regulatory requirements for post-market surveillance.
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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