QPRG works with manufacturers of reusable medical devices and their key customers, the sterile processing departments that reprocess those devices, to enable better interactions, information flow from SPD to manufacturer and back, and to enable both to function with better likelihood of success, better patient outcomes, improved process control, and lower costs.

Spanning the range of knowledge and services required to serve this need, we are a group of sterile processing experts with expertise covering the range of:

  • Cleaning, Disinfection, Sterilization, and General Reprocessing Practice and Product Validation
  • IFU Creation and Interpretation
  • Optimization, Verification and Validation of Sterilization and Cleaning in Sterile Processing Departments
  • Wet Pack and Staining Remediation
  • Organizational Design, SOPs, Quality Manual Production for Sterile Processing Departments and Integration in the Healthcare Facilities systems
  • Systems to monitor continuing education requirements and compliance
  • Infection Control Audits and Process Improvement
  • CDC HAN 383 Reporting, Joint Commission and CMS Pre-Audits
  • Training for Industry Engineers and End-Users (SPD)
  • Post-incident evaluation, investigation, and remediation
  • FDA Filings, CAPA Consulting, and Master Product System Implementation for Medical Device Manufacturers
  • FDA Complaint Reporting for Sterile Processing Departments.