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
Your personal single-user account is valid for 90 days from the date you receive your login details. During this period, you can revisit the modules as often as you like. Upon successful completion, you will receive a personalised, qualifying certificate. The participation fee includes all accompanying materials, further information, links, and templates. All materials are available for download.
Our General Terms and Conditions (as of 01.06.2024) 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
Your personal single-user account is valid for 90 days from the date you receive your login details. During this period, you can revisit the modules as often as you like. Upon successful completion, you will receive a personalised, qualifying certificate. The participation fee includes all accompanying materials, further information, links, and templates. All materials are available for download.
Our General Terms and Conditions (as of 01.06.2024) 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
Our e-learning, specially tailored for medical device consultants, provides you with the essential knowledge to navigate your professional duties confidently and in full legal compliance.
Our e-learning course provides you with the latest legal requirements for medical device advisors - practical, concise, and flexible, at your own pace.
Upon successful completion of all modules and passing the knowledge assessments, you will receive a qualifying certificate. This certificate allows you to demonstrate your required expertise in accordance with § 83 MPDG to the relevant authority at any time.
After completing this course, you will be optimally prepared:
Robert Lindner, Esq., MLB, MHA
Prof. Dr. Stephen Gilbert
Prof. Dr. Stephen Gilbert
Prof. Dr. Stephen Gilbert
Robert Lindner, Esq., MLB, MHA
The FORUM Institute offers a flexible form of further training with high-quality e-learning courses on various topics. You can access the best know-how from anywhere.
You book an e-learning course, which consists of several didactically prepared learning modules. The main component of our e-learning courses are videos in which experts share their knowledge on the respective subject area with you. The e-learnings also contain supplementary material, such as additional documents, links, practical cases or checklists. Furthermore, the learning modules of many e-learning courses are designed to be interactive with learning tasks and exercises. This gives you the opportunity to become active yourself and to deepen your new knowledge by putting it into practice.
Each learning module ends with a learning success check. Once you have completed all the modules and successfully passed the learning success checks, you will be issued with a qualifying certificate, which you can conveniently print out straight away.
How exactly does it work?
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
This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeabl...
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...
Try out our e-Learning programmes free of charge and without any obligation.
DetailsOur options in German language: Medizinprodukteberater gemäß § 83 MPDG (Basics) and Refresher Medizinprodukteberater ge...
DetailsWe are now officially certified to ISO 9001 and ISO 21001 standard.
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
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