Insights into the applicability and general structure of the EU-MDR
Webcode 22092501
Jan Bart Hak
ProPharma Group, Leiden, The Netherlands
Head Medical Device Department;
Jan-Bart Hak is heading the medical device department of ProPharma Group, in Leiden, the Netherlands. He and his team provide services, internationally, in various medical device related areas such as quality management systems, regulatory affairs, clinical strategy, vigilance and product development.
Prior to ProPharma Group, Jan Bart held different management positions in clinical and regulatory affairs at international oriented companies, such as Xendo, QPS and Cordis (Johnson & Johnson). He also worked at a start-up company in biodegradable medical devices, which is currently a successful company. As a Medical Biologist, Jan Bart holds a Ph.D. degree in cardiac physiology.
More information please click here.
Krysten Oates
ProPharma Group, Leiden, The Netherlands
Consultant, Medical Device Department;
Krysten Oates is a Consultant on the medical device team of ProPharma Group in Leiden, the Netherlands. As part of the team, she provides guidance to international companies regarding device-related topics such as quality management systems, regulatory affairs, clinical strategy, vigilance and product development.
Prior to joining ProPharma Group, Krysten worked as a Senior Consultant in the technology transfer and commercialization area, conducting market analyses and developing market entry/regulatory strategies for small- to mid-sized companies to guide their innovations to market. She also worked for a small spin-off company that developed body-powered prostheses in the Netherlands. Krysten holds a MSc degree in Biomedical Engineering with a concentration in biomechanics and prosthetic devices.
More information please click here.
08.09.2022
08.09.2022
9:00-17:00
online
online
Veranstaltung - 1.090,- € zzgl. MwSt.
The fee includes comprehensive documentation and a personalised certificate that can be downloaded.
Veranstaltung - 1.090,- € zzgl. MwSt.
The fee includes comprehensive documentation and a personalised certificate that can be downloaded.
Antje Bauer
Conference Manager
+49 6221 500-655
a.bauer@forum-institut.de
Learn the essentials of the MDR and how to navigate around the legislation and to apply it.
The MDR is a comprehensive set of rules that is a challenge at best, especially for people from outside the medical device industry. In this online crash course, you will learn how to apply the MDR, what it covers and where you can find specific references.
Among other things, you will learn what a medical device is, how it is classified, what the roles of manufacturers, authorised representatives, importers and distributors (MAID) are, and what requirements the MDR places on quality, safety and performance.
Eliminate any ambiguities and get an overview of the peculiarities of the MDR.
This online course addresses employees who have just started in the field of medical devices and need the essentials of the Medical Device Regulation.
This includes beginners as well as professionals switching area of expertise, e.g., from a pharmaceutical company to a medical device company. However, anyone needing an update on the MDR will also benefit from this crash course.
The interactive online format allows you to attend from wherever you want. Our two experts will be happy to answer any questions you may have and will cover the essentials of the MDR, enabling you to navigate around the legislation.
The Zoom webcasts are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live, using the chat function.
1. You will receive brief instructions on how to use Zoom online seminars beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Use the chat function to ask questions
Overall score of all evaluations in 2021
Five stars on Trustpilot = Excellent
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