08-032-24-EN

Post-Market-Surveillance (PMS) und Post-Market-Clinical-Follow-up (PMCF) von Medizinprodukten

Präsenztraining​1 DayBeginnerVirtuelles Klassenzimmer

Post-market surveillance (PMS) and post-market clinical follow-up (PMCF) are central components of market surveillance and are mandatory. Due to the Medical Device Regulation (MDR, 2017/745), there are numerous additions and innovations that manufacturers must implement for the market surveillance of their products. These are intended to contribute to the monitoring of residual risks, the identification of potential new risks and the verification of the performance of the products placed on the market through continuous assessment in order to ensure that safe and high-performance products with a proven benefit are on the market.

The implementation of the new requirements is monitored by the notified bodies, which are required by the MDR to carry out regular inspections to check compliance with the PMS/PMCF strategies and their documentation.

This training is also offered in German, you can find the link here.

  • You will learn the legal requirements of the Medical Device Regulation (MDR) for PMS/PMCF in a concentrated manner.
  • You will get an overview of the importance of vigilance in the context of market monitoring.
  • You will gain knowledge about the implementation of the requirements for PMS/PMCF in the company.
  • Requirements for PMS/PMCF according to the MDR
  • Role of PMS and PMCF within the product life cycle of your medical device
  • Role of economic operators in PMS
  • Importance of vigilance as part of PMS
  • Implementation of PMS/PMCF requirements within the company
  • Documents within the scope of PMS/PMCF
  • Requirements by MDR to authorities and Notified Bodies
  • with regard to market surveillance

Certificate of attendance from TÜV SÜD Academy

  • Quality Management
  • Regulatory Affairs
  • Clinical Affairs
  • Product Management
  • Project Management
  • Consultant in the medical device industry
  • Service provider for clinical studies with medical devices
  • As a participant, you will receive an edition of the pocketbook Medical Device Regulation (MDR).
Nettopreis (exkl. USt.)
ab759,00 €

Termin buchen
Seminar buchen: Post-Market-Surveillance (PMS) und Post-Market-Clinical-Follow-up (PMCF) von Medizinprodukten
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Ab 11.09.2024
Online
759,00 € exkl. USt.

Veranstaltungsnr.
9622

Dauer
​1 Day

Seminarplan anzeigen

Veranstaltungsort
Online

Preis

Nettopreis
759,00 €
20% USt.
151,80 €

Bruttopreis
910,80 €
Wie läuft eine Online-Prüfung ab?

 

Informationen zu den Anforderungen und dem Ablauf unserer Online-Prüfungen finden Sie hier.

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