2024-04-12 2024-04-12 , online online, 390 € zzgl. MwSt. Prof. Dr. Stephen Gilbert https://www.forum-institut.de/seminar/24122544-e-learning-medical-device-advisor-mpdg/referenten/24/24_12/24122544-e-learning-medical-device-advisor-mpdg_gilbert-stephen.jpg e-Learning: Medical Device Advisor (MPDG)

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!

Topics
  • European medical device law and its application in Germany
  • The MDR and IVDR - an overview of all relevant innovations for medical device advisors
  • What a medical device is and how it is brought to market
  • Current requirements and tasks of medical device advisor
  • Vigilance and market observation


Who should attend
  • You inform professionals about medical devices or in vitro diagnostics and are a medical device advisor?
Your employer has to prove that you have trained according to § 83 MPDG?
  • You are a member of the internal or external sales force?

Then you are in the right place. With this online training you can get the necessary knowledge step-by-step at your own learning pace with free time management.
e-Learning for medical device advisors (§ 83 MPDG)
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.
Your benefit

What do you take away from our e-learning?

  • You know the regulations of the medical device legal framework (both MDR and IVDR, and national implementation like MPDG etc.) and your tasks and duties as a medical device advisor.
  • You acquire the required expertise according to § 83 MPDG.
  • You can prove your expertise to your competent authority upon request with our certificate.
  • Valuable tips make it easier for you to implement your reporting and cooperation obligations.

e-Learning: Medical Device Advisor (MPDG)

Medical Device Advisor (Medizinprodukteberater)

according to § 83 MPDG:
Training and e-Learning for non-German speaking employees

Benefits
  • Up-to-date expert knowledge on-demand
  • Individual time management
  • Continuing education where you want
  • Learning success checks

Webcode 24122544

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Referenten


Alles auf einen Blick

Termin

anytime

anytime

Zeitraum

online

online
Veranstaltungsort

online

online

Downloads
Gebühr
Your contact

Verena Planitz
Conference Manager

+49 6221 500-655
v.planitz@forum-institut.de

Details

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!

Topics

  • European medical device law and its application in Germany
  • The MDR and IVDR - an overview of all relevant innovations for medical device advisors
  • What a medical device is and how it is brought to market
  • Current requirements and tasks of medical device advisor
  • Vigilance and market observation


Who should attend
  • You inform professionals about medical devices or in vitro diagnostics and are a medical device advisor?
Your employer has to prove that you have trained according to § 83 MPDG?
  • You are a member of the internal or external sales force?

Then you are in the right place. With this online training you can get the necessary knowledge step-by-step at your own learning pace with free time management.

e-Learning for medical device advisors (§ 83 MPDG)

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.

Your benefit

What do you take away from our e-learning?

  • You know the regulations of the medical device legal framework (both MDR and IVDR, and national implementation like MPDG etc.) and your tasks and duties as a medical device advisor.
  • You acquire the required expertise according to § 83 MPDG.
  • You can prove your expertise to your competent authority upon request with our certificate.
  • Valuable tips make it easier for you to implement your reporting and cooperation obligations.

Detailed programme

online

Module 1: European Medical Device law and its Application in Germany
  • Hierarchy of norms
  • Current European legal framework
  • Previous national regulations and what happens to them
  • Standards. What are they?

Module 2: The REGULATIONS (EU) 2017/745 on medical devices and (EU) 2017/746 on in vitro diagnostic medical devices
  • Obligations of economic operators
  • UDI, Eudamed, DMIDS
  • Notified bodies
  • Post-market surveillance (PMS)
  • Practical implications for Medical device manufacturers and advisors
  • PRRC

Module 3: What a medical device is and how it is brought to market
  • Meaning of the CE marking: Purpose, CTS and GSPR
  • Classification
  • Technical and clinical development
  • Validation and verification
  • Product documentation
  • Risk management and risk analysis
  • Product labelling
  • Symbols and marking (DIN EN 980)
  • Declaration of conformity, CE marking

Module 4: Current Requirements and Tasks of Medical Device Advisor
  • Qualification, function and tasksof a medical device consultant
  • Active medical devices according to MPBetreibV and obligation to instruct by manufacturer?
  • Cooperation with and tasks of PRRC
  • Cooperation with health care professionals
  • Obligation to cooperate
  • (Regular) training(s) and obligations of the medical device/IVD manufacturer
  • How to proof your expertise

Module 5: Vigilance and Market Observation (Medical Device Monitoring and Reporting System)
  • Basics of the vigilance system
  • Higher federal authorities and competent authorities in Germany
  • What is an incident?
  • Your obligation to report: What, when, how (quickly), where must be reported and who must report?
  • Who is responsible for "false reports" or "not reporting"?
  • Risk management by the competent authorities
  • New reporting obligations in medical devices vigilance (PMS, PSUR, SSCP)

Trailer

e-Learning: Medical Device Advisor (MPDG)

Here you can get a brief insight into the e-Learning Medical Device Advisor (MPDG).


Stephen Gilbert and Robert Lindner

FAQs

What is a Medical Device Advisor?

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.

German "Medizinprodukteberater § 83 MPDG" for English speaking employees

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:

  • European regulations and the German medical device law
  • What a medical device is and how it is placed on the market
  • Requirements and tasks of medical device advisors
  • Vigilance and market surveillance (monitoring and reporting system)

Our e-learning concept in details


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?

  • 1. You book the e-learning course on our website.
  • 2. You will receive an e-mail with your login details for our customer portal and will be redirected to the learning platform from there.
  • 3. You start individually with your learning modules.
  • 4. You complete the respective modules with a learning success check.
  • 5. After successfully completing all modules, you will receive a certificate that you can print out at your convenience.

Test the DEMO version of our e-learning free of charge and get an insight into our learning world!

This distinguishes our events

of 5 stars of all ratings from 2023

of 5 stars on Trustpilot = good

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Go forward

Trailer

Watch the trailer for our e-Learning programme "Medical Devices Advisor (MPDG)".

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e-Learning - Click and learn

We provide flexible education and training with high-quality e-Learning programmes for several topics. You can access to...

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Try out our e-Learning programmes for 14 days without any obligation.

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Testimonials

- 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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