The regulations involved in manufacturing and marketing a medical device can be daunting. We can help you determine the regulations that apply to you. Let us answer your questions and help guide you through the process.

Kelly Device specializes in FDA submissions and compliance that are effective and economical. We design processes to fit the budget of start-up firms but that also grow naturally with the firm.

Kelly Device is readily available for clients in North Carolina, South Carolina, Virginia, and the surrounding areas.

Kelly Device is an independent consulting group led by Bob Kelly. He has more than twenty years experience in all phases of medical design and development, particularly Class 2 devices, which are submitted via the 510k process.

His experience spans cardiovascular devices with Edwards Laboratories, combination products with VLI Corporation, and disposables for gastroenterology with Wilson-Cook and Wiltek.

Bob has extensive experience with compliance to the FDA QSR; he has created numerous quality systems including compliance for CE marking for European markets.

Bob has degrees in engineering (UVA), business (Indiana) and is RAC certified.