🇨🇿 Risk Management III – The Most Difficult Parts of Risk Management in MDR and IVDR

The event is held in Czech language only!

The last of three webinars on risk management for medical devices according to EN ISO 14971:2020 and ISO/TR 24971:2020. During the three online sessions we will explain the basic concepts and their differences from those defined by MDR/IVDR and take you through the entire process of risk management for medical devices, including practical examples of good and bad practice. In this last seminar, we will focus on the most difficult parts of risk management. Participants will especially appreciate discussing possible approaches for determining benefit-risk ratios and linking risk management to other parts of the technical documentation.

Participants who want comprehensive training in medical device risk management are recommended to complete all three modules, however, the online seminars are designed to be easily understood by participants who want to improve only in individual sub-areas.

Lecturers:

• Barbora Charvátová
• Kristýna Zobalová

Content:

• risk control, including ways of verifying the implementation and effectiveness of measures
• benefit/risk ratio 
• assessment of the overall residual risk
• analysis of the main differences between EN ISO 14971 and MDR/IVDR
• available methods and approaches for determining the benefit/risk ratio
• activities related to the collection and review of relevant production and post-production information
• essential related parts of the MDR/IVDR technical documentation and their links to risk management

Individual topics will be supplemented by:

• examples of good and bad practice
• examples of real non-conformities from notified bodies on the topics discussed
• practical exercises for participants

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

Related webinars:

• 21ˆ Nov 2024 – Risk Management I – The Basics You Can't Do Without
• 5 Dec 2024 – Risk Management II – Risk Analysis and Assessment in Practice

Participation fee:

• 3.900 CZK excluding VAT
• 9.900 CZK excluding VAT when ordering all three risk management webinars
• 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant