In this expert-led e-learning course, you will learn step by step how to conduct targeted and successful literature research as part of your clinical evaluation and document it in accordance with MDR – using your own medical device as an example.
Our e-learning platform provides a comprehensive insight into the requirements for literature research and teaches you how to implement them easily using suitable methods. It enables you to obtain relevant data on the state of the art and, if necessary, clinical data on your own medical device.
We have not yet received any written feedback on this course.
Our expert will show you how to optimize your literature search with a systematic search strategy. This strategy not only saves you a lot of time, effort, and stress when searching for literature but can also spare you unnecessary clinical investigations and, thus, additional costs.
The e-learning course consists of various videos and tasks in which you perform a complete literature search and evaluation for one of your devices and document it in accordance with the MDR. You will benefit from our proven templates for literature search reports and protocols.
Four remote sessions with our expert accompany the course. Use these not only to clarify any questions you may have on the individual topics but also for discussions and an intensive exchange of experiences with the other participants.
Upon successful completion of the course, you will receive a certificate attesting to your newly acquired expertise in literature research in accordance with MEDDEV 2.7/1 rev. 4. Upon request, we can also have your final literature file reviewed and evaluated by our expert team.
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+49 7531 94500 20
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The course covers the following topics:
After the course, you will:
This course is designed for:
Participants can easily follow this course 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 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 the course, you will receive two e-mails: The first contains the final link to the sessions and the second contains the access data to a cloud folder in which you will find documents for preparation, exercises, and presentations.
On your first day, you'll get the login details for the e-learning platform, the dates for the four Q&A sessions, and your course schedule.
The course consists of the following components:
Please refer to the information sheet for the exact schedule.
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. Anja Kuhnert is a highly qualified regulatory and quality affairs expert with more than ten years of experience bringing medical devices to market. She is well versed in implementing and maintaining quality management systems in accordance with DIN EN ISO 13485 and in clinical evaluations in accordance with Regulation (EU) 2017/745. She has developed and coordinated approval strategies for medical devices in various risk classes. Her structured, results-oriented approach and scientific curiosity make her an experienced consultant with comprehensive clinical evaluation and post-market surveillance expertise.
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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