🇨🇿 Effective Risk Management in Practice II
The second of the two-part webinar builds seamlessly on the previous topics and focuses on the advanced stages of risk management, measures for controlling risks, and their proper integration into key sections of the technical documentation.
Date
04 Nov 2026, 09:30 – 12:00
Online: Cisco Webex
About
The event is held in Czech language only!
Risk management does not end with the creation of baseline documents; rather, it is an ongoing process that must reflect new findings throughout the entire life cycle of a medical device. Selecting the appropriate measures to control individual risks and establishing suitable procedures for collecting relevant information are key prerequisites for meeting the requirements of the MDR and IVDR.
The follow-up second part of the webinar, dedicated to risk management in practice, will therefore focus primarily on risk control measures, their implementation, and verification of their effectiveness, as well as on the collection and review of manufacturing and post-market information and the relationship between other parts of the technical documentation and risk management. The webinar will include examples of good (and bad) practices and real-world nonconformities from notified bodies.
Who the webinar is for:
Manufacturers’ regulatory specialists
Quality managers
Persons responsible for regulatory compliance (PRRC)
Medical device design and development engineers
Lecturers:
Ing. Kateřina Sinevičová
Ing. Petr Votava
Content:
Linking risk management to the application of usability techniques in accordance with EN 62366-1
Risk assessment, including methods for verifying the implementation and effectiveness of measures
Benefit-risk ratio, assessment of overall residual risk
Activities related to the collection and review of relevant manufacturing and post-market information
Key relevant sections of the technical documentation under the MDR/IVDR and their links to risk management
Examples of best and worst practices, as well as examples of actual nonconformities from notified bodies
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 s.r.o.
ID: 03301931, VAT: CZ03301931
Registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město