🇨🇿 Behind the scenes: typical non-conformities from notified bodies
Do you want to minimize the risk of unexpected findings during your next audit? Join the online seminar for medical device manufacturers and gain practical know-how to successfully prepare for an audit from a notified body.
Date
16 Sept 2025, 09:30 – 12:00
Online: Cisco Webex
About
The event is held in Czech language only!
An audit by a notified body can be stressful and challenging - deficiencies in the technical documentation or quality management system can lead to delays in the assessment of your device and costly corrective action. Are you a medical device manufacturer and don't want to pay for unexpected deficiencies in your next audit? Stay one step ahead! Join our online seminar and get valuable advice and recommendations on what to look out for in the technical documentation and in the quality management system. We will look at an overview of common non-conformities and documents that auditors have focused on in our experience so far. We will share our recommendations on how to behave, communicate and thus handle the audit with insight and confidence. As a bonus, we will mention SUKL's audit findings. Don't wait - get ready for the audit before the auditor comes knocking.
Who the webinar is for:
regulatory specialists of manufacturers
quality department staff of manufacturers
anyone working in the medical device industry who wants to broaden their horizons in this field
Lecturers:
Magdalena Folkmanová
Sidónia Molitorisová
Content:
non-conformities in technical documentation according to MDR
nonconformities in the quality management system according to MDR
checklist of critical documents
ten recommendations for audit behavior
SUKL's recurring audit findings
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:
3.900 CZK excluding VAT
100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant
Webinar hosted by:
Porta Medica
ID: 03301931, VAT: CZ03301931
registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město