2025-02-22 2025-02-22 , online online, 225 € plus tax Robert Lindner, Esq., MLB, MHA https://forum-institut.com/seminar/25122541-e-learning-medical-devices-basics-a-quick-introduction/referenten/25/25_12/25122541-e-learning-medical-devices-basics-medical-devices-basics-a-qu_lindner,-esq,-mlb,-mha-robert.jpg e-learning: Medical Devices Basics - A Quick Introduction

Gain essential knowledge for your entry into the medical device industry in just 90 minutes! Understand regulations, market access, and vigilance with our compact e-learning.

Topics
  • European Medical Device Law and its Application in Germany
  • Definition of a medical device is and how it is brought to market
  • Vigilance / Market Observation (MD Monitoring and Reporting System)


Who should attend
  • Employees of medical device manufacturers and distributors with little or no experience in regulatory and quality affairs.
  • University graduates or young professionals with a medical or scientific background who want to prepare for a career in the regulatory and quality departments of medical device companies.
Aims and objectives
Are you new to the MedTech industry or transitioning from another field?

Then our e-learning is perfect for you! In three modules, you will learn the fundamentals of medical device regulations in EU and germany, how medical devices enter the market, and how the reporting and monitoring system works.

Get a comprehensive overview in just 90 minutes!
Your benefit

By the end of this e-learning, you will:

  • Understand the European medical device law and its application in Germany.
  • Be able to define what qualifies as a medical device and explain the process of bringing it to market.
  • Comprehend the vigilance system, including market observation, monitoring, and reporting requirements for medical devices.

25122541 e-learning: Medical Devices Basics: Medical Devices Basics - A Qu

Medical Devices Basics - A Quick Introduction

E-learning with 3 modules: Medical Device Law, Development and Conformity Assessment, Vigilance

Benefits
  • Up-to-date expert knowledge
  • Flexible learning at your own pace
  • Qualifying certificate
  • Practical examples and case studies
  • Official certification according to ISO 9001 and ISO 21001

Webcode 25122541

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

Details

Gain essential knowledge for your entry into the medical device industry in just 90 minutes! Understand regulations, market access, and vigilance with our compact e-learning.

Topics

  • European Medical Device Law and its Application in Germany
  • Definition of a medical device is and how it is brought to market
  • Vigilance / Market Observation (MD Monitoring and Reporting System)


Who should attend
  • Employees of medical device manufacturers and distributors with little or no experience in regulatory and quality affairs.
  • University graduates or young professionals with a medical or scientific background who want to prepare for a career in the regulatory and quality departments of medical device companies.

Aims and objectives

Are you new to the MedTech industry or transitioning from another field?

Then our e-learning is perfect for you! In three modules, you will learn the fundamentals of medical device regulations in EU and germany, how medical devices enter the market, and how the reporting and monitoring system works.

Get a comprehensive overview in just 90 minutes!

Your benefit

By the end of this e-learning, you will:

  • Understand the European medical device law and its application in Germany.
  • Be able to define what qualifies as a medical device and explain the process of bringing it to market.
  • Comprehend the vigilance system, including market observation, monitoring, and reporting requirements for medical devices.

Detailed programme

online

Robert Lindner, Esq., MLB, MHA

Module 1: European Medical Device Law and its Application in Germany
  • General Overview of Law in Europe
  • General Overview of Law in Medical Device Laws in Germany
  • Database for Medical Devices in Germany
  • MDCG Guidances and ISO Standards for EU Regulatory Compliance

Prof. Dr. Stephen Gilbert

Module 2: Definition of a medical device is and how it is brought to market
  • Definition of medical device and in vitro diagnostic medical device
  • Path to CE Marking
  • Intended Purpose
  • Classification (Class I - Class III)
  • Technical Documentation
  • Clinical Evaluation and Clinical Investigation
  • Risk Management
  • Design, Verification and Validation
  • Conformity assessment procedure and declaration of conformity
  • Product Documentation

Prof. Dr. Stephen Gilbert

Module 3: Vigilance / Market Observation (MD Monitoring and Reporting System)
  • Basics of the Vigilance System
  • Higher Federal Authorities and Competent Authorities
  • The Obligation to Report

FAQs

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 interactive learning modules. Our e-learning stands out through a combination of text elements, graphics, videos, audio tracks, and quiz questions. The multimedia design ensures a varied and engaging presentation of the content, going beyond plain text to create a comprehensive, multi-dimensional learning experience.

Each module is self-contained. Upon completion of all modules and successful performance in the learning assessments, participants will receive a qualifying certificate.

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!

How is the e-learningstructured and how long does it take?

The e-learning course "Medical Devices Basics - A Quick Introduction" consists of three learning modules that combine text elements, graphics, videos, audio tracks, and quiz questions. The multimedia design ensures a varied and engaging presentation of the content, going beyond plain text to create a comprehensive, multi-dimensional learning experience.
The corresponding presentation materials can be downloaded.

Each learning module lasts approximately 15 to 50 minutes and concludes with a knowledge check. Every module is self-contained and can be completed individually as often as you like within 90 days. Once all modules have been completed and all knowledge checks successfully passed, a qualifying certificate will be issued.

The entire training takes an average of 90 minutes, plus the time required for the knowledge checks.

Please note: The total duration of the e-learning course may vary significantly depending on your individual reading speed and learning pace.

Is there an exam? How do you receive your certificate?

At the end of each module, a knowledge check is conducted in the form of an online test. Each test consists of 6 to 8 questions (single or multiple choice), of which 75% must be answered correctly to pass.

Once you have passed all modules and passed the quiz, you will receive a qualifying certificate issued by the FORUM Institut für Management.

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