The supreme goal of risk management for medical devices is to eliminate or minimise risks by means of conceptual measures or design. Systematic risk analysis in accordance with the EN ISO 14971:2012 standard assists with the identification and estimation of risks.
After attending this seminar you are familiar with the fundamental requirements for risk analysis of medical devices in accordance with the applicable standards. You are able to implement the risk analysis process in your company. You know how to proceed in risk analysis and how to document the results correctly. On day 2 of the seminar, you have ample opportunity to practise the risk analysis process step-by-step on specific case studies and discuss any problems you may encounter in the course of implementation with our experts.
Day 1: Applicable standards and how to use them
- Applicable standards
- Terms and definitions
- Risk analysis, risk management
- Risk analysis process
- Risk evaluation and control
- Implementation of risk analysis: estimation of risks
- Estimating the severity of harm
- Estimating the probability of occurrence
- Estimating the total risk
- Examples of form and documentation
- The role of risk analysis in the design process
- The effect of risk analysis on the QM system
- How to incorporate significant additional information from ISO/TR 24971 into risk management in a meaningful manner
Day 2: Practice-focused workshop
- Practical implementation of the standards
- Implementation of risk analysis
Who should attend
Individuals involved in the risk-analysis process:
- QM Representatives
- Safety experts for medical devices
- Product managers, designers
- Personnel in charge of approval and design
- Personnel in regulatory affairs
certificate of attendance TÜV SÜD Akademie
This seminar forms part of modular qualification. Following successful completion of the advanced modules, you can obtain the following recognised qualifications:
- Manager Regulatory Affairs– TÜV
- Specialist Medical Software – TÜV
- 1st and 2nd Party Process Auditor Medical Devices – TÜV
This seminar addresses internationally valid standards and can also be held abroad.
TÜV SÜD Akademie senior expert trainers
- Acquire the know-how you need for establishing the risk management system required for medical devices.
- Learn how to carry out risk analyses for medical devices in compliance with the standard.
- Know how to implement EN ISO 14971:2012 in your company.