First we define the scope and strategic approach together with you and agree on a time frame including any deadlines that need to be met. This is followed by the exchange of all necessary information.
An initial Risk Management Plan (RMP) is drafted and the level of risk is determined. If an RMP is already in place, it is updated according to the lifecycle phase and update requirements which apply to the medical device.
Maßnahmen zur Risikokontrolle werden festgelegt, einschließlich der Bewertung des Restrisikos. Risk control measures are defined, including the assessment of residual risk.
Finally, there is a risk/benefit analysis of the individual risks.