🇨🇿 Risk Management I – The Basics You Can't Do Without

The event is held in Czech language only!

This is the first of three webinars dedicated to 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 according to MDR/IVDR and take you step-by-step through the entire process of risk management for medical devices, including practical examples of good and bad practice. In the first webinar, we will work together to create solid building blocks for further risk management education. In particular, we will explain in clear terms what sub-processes are involved in risk management, explain the basic concepts and present the practical connections between hazard, hazardous situation and damage.

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

Lecturers:

• Barbora Charvátová
• Kristýna Zobalová

Content:

• risk management process according to EN ISO 14971 and ISO/TR 24971 and other related standards – EN 62366-1, EN 62304 and EN ISO 10993-1
• explanation of the basic concepts - risk and residual risk - how the concepts differ according to the standards and according to MDR/IVDR
• hazard, hazardous situation and damage
• risk management plan

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:

• 5 Dec 2024 – Risk Management II – Risk Analysis and Assessment in Practice
• 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