INSTRUMENT REPROCESSING   SURETEK PRODUCTS   SERVICE METRICS   SURETEK QUALITY   ABOUT SURETEK    
                               
    SureTek was founded to provide high quality surgical reprocessing services at the lowest possible cost.  Company resources are allocated at the highest priority to qualified personnel, equipment and processes that directly impact the quality of our products and services.  By eliminating the traditional 40% of cost of goods due to sales and distribution fees, SureTek is able to return greater cost savings as compared with competing reprocessors. Our 5-7 day turnaround time provides material managers with effective means to control inventory levels and acquisition costs of single-use devices.    
       
       
       
       
       
       
       
    Company and Facility:  SureTek is an employee-owned company in Greenville, SC.  Our location reduces the time and expense of shipping to and from competing reprocessing companies headquartered in the western U.S. Clients along the I-85 corridor of Georgia, South and North Carolina receive regularly scheduled pick-up and delivery.    
       
       
       
       
    Regulatory Compliance:  As a reprocessor of single use devices, SureTek is regulated by the FDA Center for Devices and Radiological Health with requirements to register its facility, list its products, obtain premarket clearances for non-exempt products and maintain an effective quality system in conformance to current Good Manufacturing Practices/Quality System Requirements (cGMP/QSR). Every device is reprocessed under established protocols, including test and inspection by a qualified biomedical engineer or surgical tech with a thorough understanding of the design and intended use of each instrument.  SureTek decontamination, refurbishing, packaging and sterilization processes and controls undergo rigorous validation testing in accordance with ISO and ASTM standards and FDA guidelines for product safety and effectiveness.    
       
       
       
       
       
       
       
       
    SureTek CEO/President:  Mike Sammon received his Ph.D. in Biomedical Engineering from Case Western Reserve University with postdoctoral training at Dartmouth School of Medicine. Dr. Sammon was an Assistant Professor at UMass Medical Center, an Adjunct at Worcester Polytechnic Institute and Clark University Graduate School of Management and has published 9 research articles for Journal of Applied Physiology and Annals of Biomedical Engineering.  Prior to founding SureTek, Mike was Manager of Clinical Services for CardioCommand and Director for Vanguard Medical Concepts and MediSISS.  He is an industry expert in medical device design, process engineering and controls, quality systems, regulatory compliance, clinical sciences and risk management. Dr. Sammon served as industry representative during legislative sessions for the Medical Device User Fee and Modernization Act of 1992 that codified product labeling, premarket requirements and quality system regulations for reprocessors into federal law.    
       
       
       
       
       
       
       
       
       
       
     
  SureTek Medical    25 Maple Creek Circle  Suite B   Greenville, SC  29607     Phone 1.864.299.9743