🇨🇿 Manufacturer's Post-marketing Activities III – Vigilance

The event is held in Czech language only!

The webinar on medical device vigilance is not only for manufacturers, but also for distributors and importers. The webinar will explain the basic terminology and processes of vigilance in accordance with the MDR, and will detail the steps in the vigilance process according to the best practices described in the available guidelines, in particular MDCG 2023-3. We will focus on setting up the vigilance process within a quality management system (QMS), using insights from notified bodies and supervisory authorities. We will also clarify the role of distributors and importers in this process. We will then translate this theoretical knowledge into practice through concrete real-life examples.

Lecturers:

• Barbora Charvátová
• Veronika Moravová

Content:

• Concepts and definitions
• obligations of manufacturers
• MDR requirements in practice
• MDCG 2023-3
• reporting deadlines and methods
• vigilance within the manufacturer's QMS
• role of distributors and importers

Related webinars:

• 5 Sep 2024 – Manufacturer's Post-marketing Activities I – Post-marketing Surveillance (PMS)
• 12 Sep 2024 – Manufacturer's Post-marketing Activities II – Post-marketing Clinical Follow-up (PMCF)

Additional information:

• During the webinar, participants will have the opportunity to ask questions
• each participant will receive a certificate of attendance
• a PDF of the presentation will be sent to all participants

Participation fee:

• 2.900 CZK excluding VAT
• 8.900 CZK excl. VAT when ordering all three related webinars
• 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant