Unannounced audits by notified bodies
Unannounced 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.
DetailsAAMI TIR 57: IT security and risk management
TIR 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.
DetailsIEC 61010-2-101: Requirements for IVD medical devices
IEC 61010-2-101 is a harmonized standard for in vitro diagnostics (IVD). IVD manufacturers can use IEC 61010-2-101 to demonstrate conformity with the general safety and performance requirements of the IVD Regulation (IVDR).
