Seminar Risk Management and ISO 14971 (two days)
Become the first point of contact for risk management in your company
This seminar will not only provide you with a comprehensive knowledge of risk management but also the capability to coordinate the required activities in your company and create the risk management files for your medical devices in compliance.
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.
Benefit from our many years of experience to get started quickly
Our seminar has matured over many years so that the content is optimally tailored to the needs of the participants. In addition to the clearly structured lectures and descriptive documents, you will benefit from numerous case studies and practical exercises. You will also receive useful tips to prevent problems in audits and during the approval of your medical devices.
You can find the exact learning content as well as the schedule of the seminar in the agenda:
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