according to § 83 MPDG:
Training and e-Learning for non-German speaking employees
Webcode 24122544
Prof. Dr. Stephen Gilbert
Technical University of 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.
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.
anytime
anytime
online
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.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@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 take away from our e-learning?
Here you can get a brief insight into the e-Learning Medical Device Advisor (MPDG).
A medical device advisor is a person who professionally informs healthcare professionals about medical devices or instructs them in their proper use. According to Section 83 of the Medical Devices Implementation Act (MPDG), such an activity may only be carried out if the consultant has the expertise and experience required for the respective medical devices to provide information and, if necessary, to instruct in the handling of the respective medical devices.
Who is allowed to work as a Medical Device Advisor?
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 keep up to date with the latest state of knowledge about the respective medical devices in order to be able to give expert advice. In addition, he or she must prove expertise to the competent authority upon request. Regular training is therefore required.
Our e-learning provides you with the information you need for your day-to-day work. With our certificate, you have the necessary proof for the medical device consultant according to 83 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:
of 5 stars of all ratings from 2023
of 5 stars on Trustpilot = good
The e-learning provides a comprehensive understanding of the German healthcare system, market access and reimbursement o...
This e-learning provides a comprehensive understanding of reimbursement in the German healthcare market, covering outpat...
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeabl...
We provide flexible education and training with high-quality e-Learning programmes for several topics. You can access to...
Details
- It is very structured & legitimate, every country must implement this - keep the good work - very good learning module - Nice and informative lectures - This e-Learning programme provided a comprehensive understanding of the various aspects of MPDG. I liked that it covered all the main points in relation to the medical device regulation and got to know the overall working of medical devices industry - I like your questiones and answers patterns. I was easy to understand. Modulus are good - E learning programme is good - Good - it was good - Good - All good
Feedbacks in 2023
