Risk management for medical devices and in-vitro diagnostics
Medical products used in or on humans carry a certain degree of risk. There is a particularly high level of protection, which is why the remaining residual risk must be weighed against the benefits of the product. German, European and American law for medical devices therefore consistently require risk management for medical devices and in-vitro diagnostics.
If these risks are not promptly identified and eliminated, this can have far-reaching consequences. According to the Medical Devices Act and the Medical Device Regulation, risk management is a mandatory requirement for all medical devices.
Our service portfolio in the field of risk management for medical devices is designed to support manufacturers in precisely meeting international standards and regulations. From extensive planning and risk assessment to the implementation of effective risk minimization strategies, we support our customers throughout the entire product life cycle.