2025-03-31 2025-03-31 , online online, 1,715 € zzgl. MwSt. Jürgen Mehring https://forum-institut.de/seminar/25092300-medical-devices-for-beginners/referenten/25/25_09/25092300-compact-seminar-on-the-entire-medical-device-development-process_mehring-juergen.jpg Medical Devices for Beginners

This seminar provides newcomers and career changers with a comprehensive introduction to European and national medical device regulations. Participants gain essential knowledge on development, classification, clinical evaluation, and post-market surveillance of medical devices. Our preparatory e-learning ensures optimal readiness for the seminar and helps deepen the practical understanding.

Topics
  • Preparatory e-learning course "Medical Devices Basics"
  • Introduction to medical devices and regulatory fundamentals
  • Classification and conformity assessment procedures of medical devices
  • Clinical evaluation and clinical investigation
  • Vigilance and market surveillance
  • Advertising of medical devices
  • Special topics: Combination products, software, and cyber security


Who should attend
The combination of e-learning and the live online intensive seminar equips newcomers and career changers in the medical device industry with essential foundational knowledge. The following departments in particular will benefit:
  • Research and Development
  • Clinical Research Regulatory Affairs
Quality Management
Aims and objectives
This seminar provides a comprehensive introduction to European and german medical device legislation. You will gain well-founded knowledge of the legal framework and the key steps required for the development and market placement of medical devices. Our experienced speakers will share valuable practical advice to help you develop, evaluate, and monitor medical devices in a safe and compliant manner.

Two weeks before the live online seminar, all participants will receive access to the preparatory e-learning course "Medical Devices Basics" (Webcode: 24122541). The course consists of three modules covering medical device legislation, development and conformity assessment, as well as vigilance. This ensures you are well-prepared and able to address your individual questions during the seminar.
Your benefit

During the seminar, you will receive:

  • A detailed introduction to the legal requirements and regulatory framework for medical devices
  • Solid knowledge of classification and conformity assessment procedures for safe market entry
  • In-depth understanding of clinical evaluation and requirements for clinical investigations
  • Insights into vigilance, post-market surveillance, and the use of reporting systems
  • Knowledge of legal advertising practices, software as a medical device, and cybersecurity requirements

25092300 Compact seminar on the entire medical device development process

Medical Devices for Beginners

Compact seminar on the entire medical device development process in compliance with the MDR and the MPDG.

Benefits
  • Including e-learning for optimal preparation
  • The medical device lifecycle in detail
  • Your entry into the MedTech industry
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25092300

Jetzt buchen

JETZT Buchen
Referenten

Jürgen Mehring

Mehring Consulting, Ahlen, GERMANY

More information please click here.

Dr. Angela Graf

Dr. Fandrich Rechtsanwälte Partnerschaftsgesellschaft mbB, Bonn

Lawyer
More information please click here.

Kirsten Sander

Aurevia GmbH, Kassel

CEO; Clinical Research Manager / Scientific & Medical Writing; M.Sc. Kirsten Sander joined Aurevia GmbH after her studies of biology. Her main focus lies in the area of medical writing, especially the preparation of publications. In this area she could gain important experience in the successful publication of numerous publications in international and national journals with different target groups.
More information please click here.

Walburga van Hövell, LL.M.

Dr. Fandrich Rechtsanwälte Partnerschaftsgesellschaft mbB, Bonn, GERMANY

Lawyer
More information please click here.

Alles auf einen Blick

Termin

04-05/09/2025

04-05/09/2025

Zeitraum

Day 1: 09:00 - 16:30; Day 2: 09:00 - 13:00. Access to the virtual seminar room opens at 08:30 on both days.

Day 1: 09:00 - 16:30; Day 2: 09:00 - 13:00. Access to the virtual seminar room opens at 08:30 on both days.
Veranstaltungsort

online

online

Downloads
Abbreviations - Medical Devices
Abbreviations - Medical Devices
Gebühr

Veranstaltung - 1,715 € zzgl. MwSt.
The participation fee includes downloadable seminar documentation, a certificate of attendance, access to the Learning Space, and full technical support, including a pre-meeting session.

Veranstaltung - 1,715 € zzgl. MwSt.
The participation fee includes downloadable seminar documentation, a certificate of attendance, access to the Learning Space, and full technical support, including a pre-meeting session.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Dr. Myriam Friedel
Conference Manager

+49 6221 500-563
m.friedel@forum-institut.de

Details

This seminar provides newcomers and career changers with a comprehensive introduction to European and national medical device regulations. Participants gain essential knowledge on development, classification, clinical evaluation, and post-market surveillance of medical devices. Our preparatory e-learning ensures optimal readiness for the seminar and helps deepen the practical understanding.

Topics

  • Preparatory e-learning course "Medical Devices Basics"
  • Introduction to medical devices and regulatory fundamentals
  • Classification and conformity assessment procedures of medical devices
  • Clinical evaluation and clinical investigation
  • Vigilance and market surveillance
  • Advertising of medical devices
  • Special topics: Combination products, software, and cyber security


Who should attend
The combination of e-learning and the live online intensive seminar equips newcomers and career changers in the medical device industry with essential foundational knowledge. The following departments in particular will benefit:
  • Research and Development
  • Clinical Research Regulatory Affairs
Quality Management

Aims and objectives

This seminar provides a comprehensive introduction to European and german medical device legislation. You will gain well-founded knowledge of the legal framework and the key steps required for the development and market placement of medical devices. Our experienced speakers will share valuable practical advice to help you develop, evaluate, and monitor medical devices in a safe and compliant manner.

Two weeks before the live online seminar, all participants will receive access to the preparatory e-learning course "Medical Devices Basics" (Webcode: 24122541). The course consists of three modules covering medical device legislation, development and conformity assessment, as well as vigilance. This ensures you are well-prepared and able to address your individual questions during the seminar.

Your benefit

During the seminar, you will receive:

  • A detailed introduction to the legal requirements and regulatory framework for medical devices
  • Solid knowledge of classification and conformity assessment procedures for safe market entry
  • In-depth understanding of clinical evaluation and requirements for clinical investigations
  • Insights into vigilance, post-market surveillance, and the use of reporting systems
  • Knowledge of legal advertising practices, software as a medical device, and cybersecurity requirements

Detailed programme

Day 1: 09:00 - 16:30; Day 2: 09:00 - 13:00. Access to the virtual seminar room opens at 08:30 on both days.

08:50

Preparatory e-learning: Medical Devices basics
  • Access to the e-learning course "Medical Devices Basics" will be granted two weeks before the start of the live online seminar. This allows you to become familiar with the terminology and gain a basic understanding of medical device law, development, conformity assessment, and vigilance.

09:00 Day 1 - Welcome and participant introductions


09:15

Dr. Angela Graf

Overview of Regulatory Foundations and Legal Frameworks
  • Which legal frameworks apply to medical devices?
  • Introduction to MDR and MPDG
  • Current transitional periods and extensions
  • Distinction between medical devices and other product categories (pharmaceuticals, cosmetics, food, dietary supplements)
  • From idea to product: A brief overview
  • Excursus: Combination products and drug-device combinations
    • Definition and legal classification
    • Article 117 MDR & consultation procedure
    • Relevant EMA guidelines

10:30 Coffee break


10:45

Jürgen Mehring

Classification, Conformity Assessment & Certification
  • How are medical devices classified and what are the legal foundations of the conformity assessment process?
  • General Safety and Performance Requirements (GSPR)
  • Requirements for technical documentation
  • Routes to CE marking
  • The role and tasks of Notified Bodies
  • Common deficiencies and how to avoid them
  • Excursus: Software as a medical device
    • Differences between embedded and standalone software
    • Software risk classification
    • Digital Health Applications (DiGAs)

12:30 Lunch break


13:30

Kirsten Sander

Clinical Evaluation and Clinical Investigations
  • What are the requirements for clinical evaluation?
  • Sources of clinical evidence
  • Impact of clinical evaluation on other regulatory processes
  • Case scenarios in clinical settings: Is a clinical investigation always required? Regulatory assessment
  • Procedures involving ethics committees and authorities
  • How to design a clinical investigation plan - and what is biostatistics?
  • ISO 14155: Clinical investigations of medical devices involving human subjects
  • Requirements for patient information and informed consent
  • Key content for the Investigator's Brochure
  • Why is monitoring important in clinical investigations?
  • Documentation requirements before, during, and after the study
  • 14:45 - Coffee break within the topic block

16:30 End of Day 1


09:00 Day 2 - Welcome


09:15

Kirsten Sander, Jürgen Mehring

Vigilance and Market Surveillance
  • What does post-market surveillance (PMS) involve?
  • What is vigilance and which reporting systems are in place?
  • The role of authorities in market surveillance
  • Incidents, serious incidents, recalls, field safety corrective actions and reporting obligations
  • Reporting obligations in the context of clinical investigations: How are SAEs reported and assessed?
  • Excursus: Cybersecurity in medical devices
    • How to protect devices from cyberattacks
    • Security testing and monitoring (e.g. penetration testing)

10:45 Coffee break


11:00

Walburga van Hövell, LL.M.

Advertising of Medical Devices
  • Legal framework according to MDR, MPDG and HWG (German Act on Advertising in the Healthcare Sector)
  • Integration of Article 7 MDR into the system of advertising law

12:30 Q&A session


13:00 End of Seminar


Further information

Access to and procedure for online events

Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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