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

Produktnummer 08-032-24-EN

Training Präsenz / Virtuell
1 Day
Beginner

Details

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.

Vorteile | Advantages

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.

Inhalte | Content

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

Abschluss | Degree

Certificate of attendance from TÜV SÜD Academy

Zielgruppe | Target group

Quality Management
Regulatory Affairs
Clinical Affairs
Product Management
Project Management
Consultant in the medical device industry
Service provider for clinical studies with medical devices

Hinweis | Note

As a participant, you will receive an edition of the pocketbook Medical Device Regulation (MDR).

Duchführende Akademie | Executing Academy

Alle Online Termine dieser Veranstaltung werden von der TÜV SÜD Akademie GmbH in Deutschland durchgeführt. Bei Onlinetrainings gelten daher zusätzlich die Allgemeinen Geschäftsbedingungen und Prüfungsordnungen sowie Datenschutzinformationen der TÜV SÜD Akademie GmbH. Bei Rückfragen stehen wir Ihnen gerne unter [email protected] zur Verfügung.

809,00 €Nettopreis

970,80 €Bruttopreis

Preisdetails einblenden

Nettopreis809,00 €

20% USt.*161,80 €

Bruttopreis970,80 €

*Kann außerhalb von Österreich abweichen

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Wie können wir helfen?

+43 5 0528 3030

[email protected]