🇨🇿 Effective Risk Management in Practice I
The first of two webinar sessions focuses on placing risk management within the context of a medical device’s technical documentation, clarifying key concepts, and properly establishing the risk management process in accordance with standards and guidance documents.
Date
21 Oct 2026, 09:30 – 12:00
Online: Cisco Webex
About
The event is held in Czech language only!
A properly established risk management process is an essential prerequisite for compliance with the MDR and IVDR requirements. However, experience shows that manufacturers often encounter challenges when linking the EN ISO 14971 technical standard with legislative requirements, when integrating it with the suitability for use assessment, clinical evaluation, or when collecting post-market surveillance (PMS) information. These shortcomings subsequently lead to frequent non-conformities on the part of notified bodies.
This first part of the webinar will provide a comprehensive overview of the topic, ranging from an explanation of basic terms and principles to the creation of a risk management plan and the process of risk analysis, assessment, and evaluation. The focus will be on practical demonstrations, examples of real-world nonconformities, and the proper implementation of requirements in technical documentation.
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:
The role of risk management in the context of medical device technical documentation
Explanation of basic terms—risk and residual risk, hazard, hazardous situation, and harm
Risk management plan
The risk management process in accordance with EN ISO 14971 and ISO/TR 24971 and other related standards (EN ISO 10993-1, EN 62366-1, EN 62304)
Risk analysis, risk assessment (probability of occurrence and severity)—qualitative and quantitative methods
Risk evaluation and risk acceptability criteria
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