e-Learning: Medical Devices Basics - A Quick Introduction

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

  • 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
e-Learning: Medical Devices Basics - A Quick Introduction

e-Learning

Ab 225,00 € zzgl. MwSt.
Leistungen & Ablauf

Buchungsdetails

e-Learning

Ab 225,00 € zzgl. MwSt.
Leistungen & Ablauf

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.

Your speakers

Robert Lindner, Esq., MLB, MHA

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…

Prof. Dr. Stephen Gilbert

Prof. Dr. Stephen Gilbert

TU Dresden - University of Technology
Else Kröner Fresenius Center for Digital Health,
Dresden, Germany

Professor of Medical Device Regulatory Science;
Prof Gilbert's primary focus is on advancing the…

What to Expect

  • 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.

Objective of the Event

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.

Programme

online

Module 1: European Medical Device Law and its Application in Germany
Robert Lindner, Esq., MLB, MHA
  • 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

Module 2: Definition of a medical device is and how it is brought to market
Prof. Dr. Stephen Gilbert
  • 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

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

Module 1: European Medical Device Law and its Application in Germany

Robert Lindner, Esq., MLB, MHA

  • 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

Module 2: Definition of a medical device is and how it is brought to market

Prof. Dr. Stephen Gilbert

  • 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

Module 3: Vigilance / Market Observation (MD Monitoring and Reporting System)

Prof. Dr. Stephen Gilbert

  • Basics of the Vigilance System
  • Higher Federal Authorities and Competent Authorities
  • The Obligation to Report

Downloads

Request the documents using our form.

Prospekt

Brochure

Abbreviations-Medical-Devices

Further Informations


Training for the World of Tomorrow

The FORUM Institute offers a flexible form of professional development with high-quality e-learning programmes across various subject areas. You can access the best expertise from anywhere.

You book an e-learning programme consisting of several didactically structured learning modules. The main component of our e-learnings is video content in which experts share their knowledge on the respective topic. The e-learnings also include supplementary materials such as additional documents, links, case studies or checklists. Many e-learning modules are designed to be interactive, featuring learning tasks and exercises. This gives you the opportunity to actively engage and deepen your newly acquired knowledge in practice.

Each learning module concludes with a learning success assessment. Once you have completed all modules and passed the assessments, you will receive a qualifying certificate that you can conveniently print out. The certificate and assessments are generated on the basis of an automated, non-individual multiple-choice test.

How does it work exactly?

1. You book an e-learning programme on our website

2. You receive an email with your login details for our learning platform

3. You log in to our learning platform using these credentials

4. You start the learning modules at your own pace

5. You complete each module with a learning success assessment

6. After successful completion, you receive a certificate that you can conveniently print out

Try out the DEMO versions of our e-learnings for free and get a first impression of our learning environment!


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.

The certificate and assessments are generated on the basis of an automated, non-individual multiple-choice test.


In-house Offers - On-site and Online

We also conduct this seminar exclusively for your company - individually tailored to your requirements, flexible scheduling and available as either on-site or online format. Contact us and we will prepare a customized offer for you.

Request a quote

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Further Information

We guarantee the highest quality

We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

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In-house seminars

In-house seminars

Our programmes are also available for in-house training. Just contact us!

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DEMO-Account e-Learning

DEMO-Account e-Learning

Try out our e-Learning programmes free of charge and without any obligation.

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Your Contact Person

We are happy to advise you personally and individually.

Our further education offerings are comprehensive. We are happy to personally match your requirements with our offerings. Let our further education experts advise you and contact us today.
Verena Planitz

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