MDR | regulatory | IVDR
How Your Medical Director Can Help You Scope SOTA Properly: A Physician's Perspective
State of the art (SOTA) is a key element of the technical documentation required for MDR/IVDR certification. As a new requirement for devices in lower-risk classes, many manufacturers are struggling to provide SOTA context that meets notified body expectations. Whether for new devices or those that have been on the market for a long time, physicians can help manufacturers overcome many of these challenges.
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