2022-09-08 2022-09-08 , online online, 1.090,- € zzgl. MwSt. Jan Bart Hak https://www.forum-institut.de/seminar/22092501-crash-course-medical-device-regulation/51/N/0/0/0/referenten/22/22_09/22092501-crash-course-medical-device-regulation_hak-jan-bart.jpg Crash Course: Medical Device Regulation

Learn the essentials of the MDR and how to navigate around the legislation and to apply it.

Topics
  • Overview of the European Medical Device Regulation
  • Responsibilities of the various parties
  • Quality management system requirements (ISO 13485)
  • General safety and performance requirements (GSPR)
  • Technical documentation and CE certification
  • Post-market surveillance: vigilance, PMCF and reporting
Aims and objectives
The MDR is a comprehensive set of rules that is a challenge at best, especially for people from outside the medical device industry. In this online crash course, you will learn how to apply the MDR, what it covers and where you can find specific references.

Among other things, you will learn what a medical device is, how it is classified, what the roles of manufacturers, authorised representatives, importers and distributors (MAID) are, and what requirements the MDR places on quality, safety and performance.

Eliminate any ambiguities and get an overview of the peculiarities of the MDR.
Who should attend

This online course addresses employees who have just started in the field of medical devices and need the essentials of the Medical Device Regulation.

This includes beginners as well as professionals switching area of expertise, e.g., from a pharmaceutical company to a medical device company. However, anyone needing an update on the MDR will also benefit from this crash course.

Crash Course Medical Device Regulation

Crash Course: European Medical Device Regulation

Insights into the applicability and general structure of the EU-MDR

Benefits
  • Meet the experts!
  • The essentials in one day!
  • Online format: modern, flexible, interactive
  • We are following the IMI quality criteria

Webcode 22092501

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

08.09.2022

08.09.2022

Zeitraum

9:00-17:00

9:00-17:00
Veranstaltungsort

online

online

Gebühr
Ihr Ansprechpartner

Antje Bauer
Conference Manager

+49 6221 500-655
a.bauer@forum-institut.de

Details

Learn the essentials of the MDR and how to navigate around the legislation and to apply it.

Topics
  • Overview of the European Medical Device Regulation
  • Responsibilities of the various parties
  • Quality management system requirements (ISO 13485)
  • General safety and performance requirements (GSPR)
  • Technical documentation and CE certification
  • Post-market surveillance: vigilance, PMCF and reporting
Aims and objectives

The MDR is a comprehensive set of rules that is a challenge at best, especially for people from outside the medical device industry. In this online crash course, you will learn how to apply the MDR, what it covers and where you can find specific references.

Among other things, you will learn what a medical device is, how it is classified, what the roles of manufacturers, authorised representatives, importers and distributors (MAID) are, and what requirements the MDR places on quality, safety and performance.

Eliminate any ambiguities and get an overview of the peculiarities of the MDR.

Who should attend

This online course addresses employees who have just started in the field of medical devices and need the essentials of the Medical Device Regulation.

This includes beginners as well as professionals switching area of expertise, e.g., from a pharmaceutical company to a medical device company. However, anyone needing an update on the MDR will also benefit from this crash course.

Detailed programme

9:00-17:00

The regulation and guidance documents
  • EU MDR and CE marking
  • Definition and classification
  • Combination products

Economic operators
  • Roles and responsibilities of the MAID
  • Competent authorities and Notified Bodies
  • Person responsible for regulatory compliance (PRRC)

Quality management system requirements
  • Article 10, 9
  • EN:ISO 13485:2016
  • Risk management

Annex I: General safety and performance requirements
  • Alignment with EN:ISO 13485:2016, clause 7.3
  • Clinical evaluation
  • Risk management
  • Summary of safety and clinical performance (SSCP)

Annex II: Technical documentation
  • Technical documentation (Annex II)
  • Notified body selection
  • Life cycle management

Clinical Evaluation
  • Purpose of Clinical Evaluation
  • Clinical Data
  • Clinical Evaluation Plan (Annex XIV) (CEP)
  • Clinical Development Plan
  • Clinical Evaluation Report (CER)

Post-Marketing Surveillance
  • PMS Plan
  • PMS Report
  • Setup and Implementation of PMS
  • PMCF
  • Vigilance

More information

Your benefits

The interactive online format allows you to attend from wherever you want. Our two experts will be happy to answer any questions you may have and will cover the essentials of the MDR, enabling you to navigate around the legislation.

How does an online seminar work?

The Zoom webcasts are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live, using the chat function.

1. You will receive brief instructions on how to use Zoom online seminars beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Use the chat function to ask questions

The benefits of an online seminar

  • online seminar - live and interactive via zoom
  • Your access data and documents always accessible in your customer portal
  • Didactically and technically well-rounded concept with plenty of room for your questions.
  • Continuous support during the online seminar for optimal learning success.

FAQ

1.) You need a reliable Internet connection and a browser. The following Windows browsers are applicable:
- Internet Explorer 8 onwards
- Mozilla Firefox
- Google Chrome

2.) We recommend using the Zoom app to connect with your mobile device.
- You will need a headset, loudspeakers, or a telephone for audio.

3.) Can I test my equipment beforehand?
- Yes, you can check whether everything will work properly on the day of your online training.
Just click the following link to run a test: https://zoom.us/test

This distinguishes our events

Overall score of all evaluations in 2021

Five stars on Trustpilot = Excellent

Recommendations

Betäubungsmittel

Dieses Seminar informiert Sie ausführlich über Ihre Verantwortlichkeiten rund um den Einsatz von Betäubungsmitteln im ph...

22.09.2022 in Frankfurt
Details

Qualitätsbedingte Variations

Online-Seminar mit Fokus: Welche Änderung in Analytik und Herstellung bedingt welchen Typ Änderungsanzeige?

04. - 05.07.2022, Online
Details

Großhandelsbeauftragte

Ein Seminar über die verantwortlichen Personen von pharmazeutischen Unternehmen und des Großhandels - die Aufgaben, Vera...

06.09.2022, Online
Details

Vigilanz für Medizinprodukte

Unsere Experten informieren Sie detailliert über das Vigilanzsystem für Medizinprodukte und das Vorgehen aus Sicht der H...

07. - 08.07.2022 in Frankfurt
Details

PharmaFORUM GMP-/GDP-Webcast

Unsere Online-Schulungsreihe informiert Sie einmal im Monat über aktuelle Themen aus dem Bereich GMP/GDP. Kommunizieren ...

01.08. - 31.07.2023, Online
Details

Go forward

e-Learning - Click and learn

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

Details
e-Learning
Technical requirements

Here you can find the technical requirements for our online events that must be met.

Details
Technical requirements
Quality guaranteed!

Quality guaranteed!

Details
More on our quality criteria