Can I read Risk Management File ISO14971 ClearSightAI on EtoBox?

Risk Management File ISO14971 ClearSightAI by N.r. Koka is a document available to read on EtoBox.

What is Risk Management File ISO14971 ClearSightAI about?

The document outlines the risk management activities for the ClearSight AI Diagnostic Imaging Platform, a Class II Software as a Medical Device designed for pulmonary nodule detection in chest CT scans. It details the risk management plan, identified hazards, control measures, and the evaluation of residual risks, emphasizing the importance of clinical validation and user safety. A formal review confirmed the implementation of the risk management plan, with ongoing post-production monitoring to be establish

Author

N.r. Koka

Language

EN