Quality Assurance Services

Libra Medical has developed and installed many Quality Assurance Systems from ground zero and has upgraded already installed Quality Assurance Systems that have passed multiple quality system audits by the Notified Body and FDA. The Quality Assurance System will be customized specifically to meet your needs and will be a compliant and robust system that reduces risks, solves problems, and supports future growth.

Services provided:

  • Full Quality System SOP Design -- QSR and ISO 13483
  • Change Control System
  • Design Control System
  • Risk Management System
  • CAPA System
  • Complaints, MDR and Vigilance
  • Vendor Management

 

  • Sterilization Validation
  • Process Validation and Control
  • Biocompatibility Testing
  • Design Verification and Validation
  • Internal and Vendor Audit
  • External Audits Management
  • Quality System Training