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.
Areas of Expertise:
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