IMDRF
The document highlights the key points regarding the regulatory approach to be applied with respect to cybersecurity-related matters associated with legacy medical devices. Table Of Contents: The International Medical Devices Regulators Forum (IMDRF), a voluntary...
IMDRF
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has announced public consultations related to the document issued recently by the IMDRF. The International Medical Device Regulators Forum (IMDRF), a...
IMDRF
The International Medical Device Regulators Forum (IMDRF), a voluntary association of medical device regulating authorities collaborating on the improvement of the legislative framework has published a position paper describing the proposed approach to the post-market...
IMDRF
The International Medical Device Regulators Forum (IMDRF), a voluntary association of medical device regulating authorities collaborating on the improvement of the existing legal framework, has developed detailed proposals related to the application of quality...
IMDRF
In the course of continuous improvement of the regulatory framework for software as a medical device (SaMD), the International Medical Device Regulators Forum (IMDRF) has developed a new approach to SaMD risk categorization and corresponding consideration. The...
IMDRF
The Medical and Healthcare products Regulatory Agency (MHRA) of the UK has updated the information dedicated to tests and testing kits intended to detect the COVID-19. The information describes how the different types of COVID-19 tests operate and provides...
