🇨🇿 Manufacturer's Post-marketing Activities I – Post-marketing Surveillance (PMS)
Join us for the first of a series of three webinars that will guide you through the key aspects of post-market surveillance of medical devices. The seminar is primarily intended for manufacturers, but it is also very beneficial for distributors and importers.
Date
05 Sept 2024, 09:30 – 11:30
Online: Cisco Webex
About
The event is held in Czech language only!
Webinar focused on post-market surveillance. We will clarify basic terminology, MDR requirements and the context of PMS within a quality management system. We will go through the possible PMS activities that can be carried out by the manufacturer. We will also focus on the structure of the PMS plan and on the form in which PMS activities must be reported in relation to the asset's risk class. We will also not forget the trend report. In conclusion, we will mention the relevance of PMS to clinical assessment and risk management.
Lecturers:
- Barbora Charvátová
- Lýdie Hojková
Contents:
- concepts and definitions
- overview of PMS activities
- the content of the PMS plan
- report on PMS
- regularly updated security report
- follow-up to risk management and clinical evaluation
Related Webinars:
- 12 Sep 2024 – Manufacturer's Post-marketing Activities II – Post-marketing Clinical Follow-up (PMCF)
- 19 Sep 2024 – Manufacturer's Post-marketing Activities III – Vigilance
Additional information:
- during the webinar, participants will have the opportunity to ask questions
- each participant will receive a certificate of participation
- a PDF presentation will be sent to all participants
Participation fee:
- CZK 3,900 without VAT
- CZK 8,900 without VAT when ordering all three webinars for viewing after the launch
- after binding confirmed registration, a 100% cancellation fee applies, but with the possibility of sending a replacement participant