Risk management is becoming increasingly important in the development and marketing of medical devices.
From development to marketing, maintenance and disposal of a medical device, risks arise to which the patient or user is exposed. These must be eliminated or minimized. In addition to regulatory requirements, which demand risk management, it should also be in the entrepreneurial interest to operate a risk management system.
With it, a risk-benefit analysis of your product can be created, analyzed and the remaining residual risk can be evaluated.
MEDTECH360 supports you very flexibly in every phase of risk management.
- Development and implementation of a risk management system
- Performing risk analyses (according to EN ISO 14971) together with your team (finding and evaluating risks)
- Creation of a risk management file
- Determination of appropriate measures to mitigate risks
- Employee training and education