- QMS implementation
- Development of ISO 14971 risk management file
Development of ISO 14971 risk management file
Risk management file refers to the manufacturer's documentation reflecting an evaluation of all possible risks associated with the production and operation of the medical device, taking into account the probability of their occurrence and measures aimed at reducing these dangers.
Our company offers the following services for the development of risk management file:
Development and description of risk management procedures;
Performing analysis of possible risks at every stage of medical device life cycle;
Formation of strategy of risk reduction and its implementation;
Preparation of risk management file, including evaluation of the effectiveness of risk management measures and acceptability of all residual risks.
During the procedure of state registration risk management file appears to be as important as technical and operational documentation for the medical device!