All medical devices have to fulfil the requirements of the basic safety standard for medical systems: the product standard IEC 60601-2-33 and its related collateral standards.The risk management process as described in the process standard ISO 14971 must also be applied by the manufacturer of the medical system. In practice, this creates many problems.
It is good to realize that it is the manufacturer’s responsibility to satisfy the requirements for this process, whereby it is also his responsibility to show the adequacy of the assumptions made during this process. The application of risk management following the framework as given in the ISO 14971 standard is an important tool to streamline the discussions. When done appropriately, it minimizes the work to be done by the manufacturers to demonstrate the overall safety of its device.
MR:comp – Your competent partner for risk management
The safety of medical devices used in the magnetic resonance (MR) environment represents the main portfolio of services by MR:comp. This service includes specific consultancies on the realization of the so-called risk management file, including the device hazard analysis as required by the international standards.
Our comprehensive consulting service addresses the risk management requirements for product improvements, new product development, and personnel training. This service is not limited to medical devices used in the MR environment but is applicable to all medical devices.
Our knowledge is based on active involvement in the development of international standards and practical experience working with medical device manufacturers.