Quality systems are required to be implemented and effective for all manufacturers of commercially available medical devices.  Our expertise is available to design, establish and maintain an appropriate and bespoke quality system for your organization or to assist with refining specific system elements.
  • Quality System Expertise (FDA Quality System Regulations / GMPs & ISO 13485)
    • Quality System Design & Implementation
    • Team Training Support
    • Quality Strategy
    • Corrective and Preventive Action (CAPA) Support
    • Complaint Investigation & Root Cause Analysis
    • Interim Quality System Management
  • Audits
    • Gap Analysis
    • Internal Quality System Audits
    • Mock FDA Audits
    • Supplier Qualification and Maintenance Audits