This article describes the requirements of the in vitro diagnostic medical device regulation (IVDR) for software development and documentation. The requirements apply to software that is part of an IVD (embedded software) and to software that is an IVD itself (“standalone” software). This article also compares the software requirements of the MDR and the IVDR.
DetailsUnannounced audits are random sampling checks of the quality management systems by notified bodies with the aim of Initial experience with unannounced audits is now available.
DetailsTIR 57 is a “Technical Information Report” from the American AAMI. It is intended to assist in recognizing and controlling risks due to inadequate IT security of medical devices, thus fulfilling the requirements of ISO 14971 for risk management.
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