🇨🇿 Risk Management II – Risk Analysis and Assessment in Practice

The event is held in Czech language only!

The second of three webinars dedicated to risk management of 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 according to MDR/IVDR and take you through the entire process of risk management of medical devices, including practical examples of good and bad practice. The second webinar will focus on the main risk management processes such as risk estimation and risk assessment. We will present many inspiring examples to the participants on how to set scales for probability of occurrence and severity or risk acceptability criteria.

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 easy to understand for participants who only want to improve in individual sub-areas.

Lecturers:

• Barbora Charvátová
• Kristýna Zobalová

Content:

• risk analysis – risk estimation – probability of occurrence and severity – qualitative and quantitative methods
• risk assessment
• risk acceptability criteria
• linking risk management to the application of the usability technique according to EN 62366-1

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
• 19 Dec 2024 – Risk Management III – The Most Difficult Parts of Risk Management in MDR and IVDR

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