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ISO/TC 210
Get your Facts Straight!
The International Organization for Standardization’s 210 technical committee (ISO/TC 210) establishes standardization of requirements and guidance for the quality management and corresponding general aspects for medical devices. When its members recently met at AAMI headquarters in Arlington, VA, Scott Colburn, director of the Standards and Conformity Assessment Program at the FDA’s Center for Devices and Radiological Health (CDRH), met with AAMI’s Robert Burroughs, chief learning and development officer, to talk about the establishment of an official ISO liaison with the Global Harmonization Working Party (GHWP), and the International Medical Device Regulators Forum (IMDRF).