Development of QMSfor Start-up, US FDA 510K Application

Client Type: Medial Device

Jurisdiction(s): USA & Canada

Services Provided: Reviewed and ascertained FDA and Health Canada regulatory requirements to determine an appropriate regulatory path to approval. Audited, reviewed and studied technical data/documentation/reports in support of compliance and drafted an audit report with corrective actions. Issued final report and assisted with corrective action plans resulting in successful attainment of FDA approval for 510(k) premarket notification submission andHealth Canada approval for a MDEL.

Additionally, the client successfully obtained a Quality Management System (includes Standard Operating Procedures or SOPs) to support product licensing and establishment licensing requirements in both the United States and Canada.