Insights into the applicability and general structure of the MDR
Webcode 24012503
Prof. Dr. Stephen Gilbert
TU Dresden - University of Technology Else Kröner Fresenius Center for Digital Health, Dresden, Germany
Professor of Medical Device Regulatory Science;
Prof Gilbert's primary focus is on advancing the regulatory science of software as a medical device and AI-enabled medical devices. He recognizes that innovative digital healthcare approaches must be accompanied by innovative regulatory approaches to ensure timely market availability and maximum patient access to life-saving treatments while maintaining safety standards.
His research interests primarily revolve around four key areas. Firstly, he is interested in data sharing and the European Health Data Space. Secondly, he explores approaches to market approval of adaptive AI-enabled medical devices. Thirdly, he investigates the realization of drug-digital/AI-enabled medical device products. Lastly, he explores the concept of digital/virtual twins as an organizing principle for the future of healthcare.
More information please click here.
Robert Lindner, Esq., MLB, MHA
Ada Health GmbH, Berlin, Germany
Senior Legal Counsel;
Robert Lindner is an innovative and successful bilingual attorney working in the digital health industry. He holds a Juris Doctor, Master of Law and Business, and Master of Healthcare Administration. With over three years of experience as in-house legal counsel and six years in international commercial transactions and renewable energy departments of prestigious law firms in Germany, including financial investments and capital markets, Robert is well-versed in negotiations and proficient in conducting research, drafting, and reviewing transactional agreements in both English and German. His detail-oriented and well-organized nature adds to his expertise in the field.
More information please click here.
22/01/2024
22/01/2024
9:00 - 17:00 - You may dial in 30 mi...
9:00 - 17:00 - You may dial in 30 min. before the session
online
online
Veranstaltung - 1,190 € zzgl. MwSt.
The fee includes comprehensive documentation and a personalised certificate that can be downloaded.
Veranstaltung - 1,190 € zzgl. MwSt.
The fee includes comprehensive documentation and a personalised certificate that can be downloaded.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de
Learn the essentials of the MDR and how to navigate around the legislation and to apply it.
The MDR presents a comprehensive framework of regulations that can be particularly challenging, especially for individuals who are not familiar with the medical device industry. Join our online crash course to acquire the knowledge and skills needed to effectively implement the MDR, understand its scope, and locate specific references.
You will gain insights into key aspects such as defining a medical device, its classification, understanding the responsibilities of manufacturers, authorized representatives, importers, and distributors (MAID), and comprehending the MDR's requirements related to quality, safety, and performance.
Eliminate any uncertainties and get an overview of the peculiarities of the MDR.
Participating in this seminar will equip you with a solid comprehension of clinical evaluation requirements, technical documentation standards, and post-marketing surveillance protocols. This knowledge will empower you to navigate the regulatory landscape more effectively and ensure strict compliance with EU MDR regulations.
Robert Lindner
Robert Lindner
Robert Lindner
Dr. Stephen Gilbert
Dr. Stephen Gilbert
Dr. Stephen Gilbert
Dr. Stephen Gilbert
FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
Overall score of all evaluations in 2022
Five stars on Trustpilot = Excellent
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