The Global Harmonization Task Force issued a guidance that provides 17 rules for device classification, according to a MassDevice report. The guidance provides rules for classification of devices and ...

Regulatory agencies are starting to catch up on their guidance agendas, including the European Union’s Medical Device Coordination Group (MDCG), which has posted a guidance for risk classification.

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The Central Drugs Standard Control Organisation (CDSCO) has announced risk classification of 119 medical devices pertaining to radiotherapy under the Medical Devices Rules (MDR), 2017, as part of ...

A team of U.S. and South Korean researchers have developed an AI model called MSI-SEER that can not only predict microsatellite instability-high (MSI-H) tumors ...