Bob Kelly has more than twenty years experience in all phases of medical design and development, particularly with Class II devices which are submitted via the 510(k) 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.
His emphasis is submissions and compliance which are effective but economical and fit the budget of start-up firms but that also will grow naturally with the firm.
Bob has degrees in engineering (UVA), business (Indiana) and is RAC certified.
Bob is readily available for clients in NC, VA, and SC and surrounding area.
Contact Information:
mobile: 336-406-9000