CortiCare provides a brain monitoring service to ICU patients in the US. We provide EEG equipment at the patients bedside, then a certified techician will monitor the patients from a remote location.
This project is to provide a short report that identifies the regulatory requirements for such an operation. Then lay out step by step pathways on how to obtain the requirements/certifications. Requirement to bid on this project: some level of US Regulatory Affairs/FDA experience.