Registration of medical device with FDA and RAQA maintenance activities to remain in compliance

Client Type: Medical Device, Regulatory Inspections

Jurisdiction(s): USA

Services Provided: Engaged in interactive review processing with the FDA and the client until 510(k) clearance. Upon successfully obtaining clearance, performed Facility Registration with the FDA. Quality system compliance activities included – SOPs, complaints, recall management, regulatory reporting, change control, internal audits, and country compliance. Regulatory Affairs services entailed amendments, facility changes, device notifications, regulatory inspection preparation, and hosting correspondence.