Darren Reeves

Mr. Reeves has been in the healthcare industry since 1988. He continually saw the myriad of ways that device companies operated in this heavily regulated industry. That knowledge, along with his own significant management experience, left him with an open mind and a creative vision.

Prior to his present efforts, Mr. Reeves was Vice President of QA/RA for the surgical division of Maxxim Medical, Inc. (formerly Sterile Concepts, Inc), a large medical device and surgical pack manufacturer. During that time his accomplishments included responsibility for QA/RA and FDA activities of nine domestic and seven international sites, including one in Canada and one in the Dominican Republic. Five sites were ISO 9001 certified and three of those sites obtained CE marking. EtO, Gamma, and e-beam sterilization activities were all under his responsibility, including one EtO facility and one gamma facility. Finally, all FDA audits and submissions, including 510(k)s, as well as all complaint, CAPA, and recall activities were under his control.

Mr. Reeves holds a Master’s degree in Business Administration (MBA) and a Bachelor’s degree in biology. He was the Director of QA/RA for Sterile Concepts (a Custom Tray Manufacturer) in Richmond, Va., responsible for the QA/RA activities for four sites in four states. He was Director of QA/RA for a surgical, disposable drape and gown manufacturer, responsible for the activities of three maquiladora operations in Mexico and a manufacturing plant in El Paso, Tx. He was also the Director of Operations for a surgical pack company in California, responsible for operations, integration and budgeting activities.