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FDA Filings for Medical Device Manufacturers

Our experience with medical device product development, standards, testing, and validation align to provide a knowledge base that allows solid, efficient preparation of FDA filings.

For sterilizers, high-level disinfectors, and endoscope washers, we can lead the charge. For other reusable medical devices, we provide guidance for testing, data acquisition, and FDA filing support that ensures the correct pathway for clearance is efficiently achieved.

Our experience and personal contact with CDRH/ODE have primed us to help you meet your goals efficiently with reasonable time and cost.

Areas of Expertise:

  • Rigid endoscopic devices
  • Flexible endoscopic devices
  • Orthopedic instruments and power tools
  • Sterilizers
    • Steam
    • Ethylene Oxide
    • Hydrogen Peroxide/Plasma
    • New Technologies
  • Washers and Washer/Disinfectors
    • For endoscopic instruments
      – Flexible & rigid/thermal
  • Chemical disinfection
    • Software and hardware validation from a risk-management approach (ISO 14971)

QPRG’s connection with various laboratories, including SMP GmbH, provides you one-stop shopping for validation, testing, and, more importantly, an engaged ongoing discussion within regulatory function and testing capabilities.

Take the first step and reach out for a consultation