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...
IMDRF
To ensure the sustainable development of innovative technologies, the International Medical Device Regulatory Forum (IMDRF) has developed a special framework for software with the intended medical purpose. Three guidance documents dedicated to terminology, risk-based...
IMDRF
The International Medical Device Regulators Forum, a voluntary association of medical device regulating authorities focused on the improvement of the regulatory framework, issued guidance dedicated to the principles and practices for cybersecurity for medical devices....
The International Medical Device Regulators Forum (IMDRF), a voluntary association of national regulating authorities focused on the improvement of the medical device regulatory framework, published a proposal on competence and training requirements for regulatory...
The International Medical Device Regulators Forum (IMDRF), an association composed of medical device regulating authorities, proposed new principles of classification of the in vitro diagnostic medical devices. The organization itself is focused on the development and...
