according to § 83 MPDG:
Training and e-Learning for non-German speaking employees
Webcode 23122331
Prof. Dr. Stephen Gilbert
Technische Universität Dresden, 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.
Esq. Robert Lindner, 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.
anytime
anytime
online
online
Event - 390 € plus tax
The fee for a single account that is valid for 90 days is € 390 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
Our General Terms and Conditions (as of 01.11.2021) apply, which we will send at any time upon request and which can be viewed on the Internet at https://www.forum-institut.com/cancellation-policy, as well as supplementary/different special conditions listed on each course website in individual cases.
Event - 390 € plus tax
The fee for a single account that is valid for 90 days is € 390 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
Our General Terms and Conditions (as of 01.11.2021) apply, which we will send at any time upon request and which can be viewed on the Internet at https://www.forum-institut.com/cancellation-policy, as well as supplementary/different special conditions listed on each course website in individual cases.
Ute Akunzius-Jehn
Conference Manager
+49 6221 500-685
u.akunzius-jehn@forum-institut.de
With our e-learning specially tailored to medical device consultants, you will receive the knowledge essential for medical device advisors - so that you can move about in your everyday professional life with legal certainty!
Our e-learning is perfectly tailored to medical device advisors: Learn which current legal requirements are placed on medical device advisors.
The focus of the 5 modules is on the regulatory framework for medical devices in the European Community and the current requirements and duties of medical device advisors.
After successful completion of this e-learning, you will be familiar with the legal framework and will be ideally equipped for your day-to-day work as a medical
device advisor.
What do you know and can you do after our e-learning?
Here you can get a brief insight into the e-Learning Medical Device Advisor (MPDG).
Many medical device manufacturers, especially those with an international presence, have non-German speaking employees who inform or instruct German Healthcare professionals.
In order for the manufacturer to comply with the legal obligation to provide regular training, the Forum Institut offers an English-language e-learning course for medical device advisors to teach the following content:
In Germany, according to § 83 MPDG (Medizinprodukterecht-Durchführungsgesetz), or in Austria, according to § 48. MPG (Medizinproduktegesetz) a medical device advisor is someone who professionally informs specialist circles or instructs them in the proper handling of medical devices.
He/she may only carry out this activity if he/she has the necessary expertise and experience for the respective medical devices to inform and, if necessary, instruct in the handling of the respective medical devices. This also applies to information given by telephone (Germany).
Anyone who
1. has successfully completed education in a scientific, medical, technical or IT-commercial profession and has been trained in relation to the respective medical devices or
2. has acquired experience in providing information on the medical devices in question and, where necessary, in instructing them in their use, by working for at least one year, which may be shorter in justified cases.
The medical devices advisor must prove his expertise to the competent authority upon request. He shall keep up to date with the latest state of knowledge about the respective medical devices in order to be able to give expert advice. The client must ensure that the medical product adviser receives regular training.
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