SOFTWARE AS A MEDICAL DEVICE

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to reach harmonization on medical device regulation. IMDRF develops internationally agreed upon documents related to a wide variety of topics affecting medical devices. In 2013, IMDRF formed the Software as a Medical Device Working Group (WG) to develop guidance supporting innovation and timely access to safe and effective Software as a Medical Device globally. Chaired by the FDA, the Software as a Medical Device WG agreed upon the key definitions for Software as a Medical Device, framework for risk categorization for Software as a Medical Device, the Quality Management System for Software as a Medical Device, and the clinical evaluation of Software as a Medical Device... As technology continues to advance all facets of health care, software has become an important part of all products, integrated widely into digital platforms that..

Primary location: Silver Spring United States