Seminar Risk Management and ISO 14971 (two days)

Gain the required knowledge to create audit-proof documentation and to defend it competently 

You will first become familiar with all relevant laws, standards, directives, and regulations, as well as their interaction in the context of risk management. This will provide you with the basis for optimally implementing your company's required risk management processes and creating a complete risk management file for your medical devices. 

Carry out risk management processes in a targeted and efficient manner in your company 

We will introduce you to the most suitable methods and approaches for risk analysis, risk acceptance, and risk minimization.
You will be able to 

• define (un)acceptable risks for your medical devices, 
• systematically identify hazards from your medical devices, 
• successfully manage the risks posed by your medical devices, and 
• integrate these activities into your development process in a meaningful way. 

You can find the exact learning content as well as the schedule of the seminar in the agenda:

Note: There is a voluntary online exam at the end of the seminar (duration: approx. 20 min). By passing this exam, you will receive a certificate proving your newly acquired knowledge and skills in addition to your attendance confirmation.