Medical Device Manufacturers

From complex medical devices to every cleaning aspect of Sterile Processing, QPRG is involved.

As active participants in the US and international medical device standards-making process and WITH active involvement with sterile processing departments, we get genuine feedback about reusable medical devices, their reprocessing, their IFUs, and the good and bad of medical device design.

The GOOD news is that we can share this vital information with you, the medical device manufacturer.

Difficulty with any design or documentation feature will lead to feedback up the chain to the doctor, and no informed doctor wants to use a device that can’t be rendered safe for use on patients.

Our experience in assisting manufacturers of reusable devices and reprocessing equipment can help streamline your design process and avoid costly device redesign. Avoid the path of others and let us work together to a better and safer means for device use.

Areas of Expertise:

• Rigid Endoscopic Devices
• Flexible Endoscopic Devices
• Orthopedic Instruments and Power Tools
• Robotic Instruments
• Sterilizers
  • Steam
  • Ethylene oxide
  • Hydrogen peroxide/plasma
• Washers and Washer/Disinfector
  • Thermal and chemical disinfection
  • Alkaline and enzyme detergents
• Design for sterilizability
• Design for cleanability
• Human factors, including design for reprocessing
• IFUs utilizing standard cycles and methods and clear writing style

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:

• 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. SMP GmbH provides testing that satisfies the requirements of both the FDA and CE marking, providing you with one solution with international application.