Język
en
Treść
The risk management process is of great importance when designing medical devices. For risk management process realization are helpful two documents: EN ISO 14971:2012 [1] Standard, and, if a medical device contains animal tissue derived substance, EN ISO 22442-1:2007 [2] Standard. The realization of the risk analysis, being the main area of the risk management, allows for the identification of a vast area of the potential unconformities concerning the performance and safety of the analyzed medical device. The application of risk analysis in design of the medical devices supports the selection of an appropriate and safe research programme in order to verify the performance, verify the stability during storage and transportation and estimate the life-span of the products [3].
The risk analysis strictly supports the appropriate estimation of the verification tests that significantly reduce the risk to an acceptable level. Risk management is the main tool useful to demonstrate the level of benefits and risks resulting from the use of a medical device as intended. Designing of medical devices is limited by the obligation to meet the essential requirements taking into the account the published standards, clinical and scientific data (literature) and validated test results.
