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 and Rigid, and for   Thermal and Chemical Disinfection)
  • Software and Hardware Validation from a Risk-Management Based Approach
  • Device History File Creation and Maintenance
  • GMP and QSR Compliance Audits and Systems Creation

FDA Filings for Medical Device Manufacturers

QPRG’s connection to SMP GmbH (and other laboratories) also allows you to have one-stop shopping for validation and testing, and, more important, an engaged, ongoing discussion between the regulatory function and the testing capability.

Let us share our experience with you

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

For sterilizers, disinfectors, and washers, we can lead the charge. For other reusable medical devices, we can provide guidance for your testing, the wrapper for the data, and the advocacy for the filing to ensure it gets through FDA to the desired clearance via the most-efficient path.

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