Bio/Data Corporation Receives ISO 13485:2003 Registration.HORSHAM, Pa. -- Bio/Data Corporation ("Bio/Data"), Horsham-based developer, manufacturer, seller and distributor of hemostasis hemostasis /he·mo·sta·sis/ (he?mo-sta´sis) (he-mos´tah-sis) 1. the arrest of bleeding by the physiological properties of vasoconstriction and coagulation or by surgical means. 2. products, announced it has received a second International Standards Organization See ISO. ("ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. ") registration. ISO is a network of the national standards institutes of 157 countries coordinated in Geneva Geneva, canton and city, Switzerland Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva. , Switzerland. Bio/Data's newly earned ISO 13485:2003 certification, specifically earmarked for medical devices, follows the 9001:2000 general-industry registration the Company achieved in 2004. Registrations acknowledge that their recipients meet internationally recognized quality standards. "This puts us on an equal footing with some of the largest global companies in our field," said William M. Trolio, vice president of the 37-year-old Philadelphia-area privately owned company. "It is a significant achievement for a small medical-device manufacturer like Bio/Data. We had to assess and expand our quality system, educate the entire company and demonstrate to the registrar that our quality system works." The ISO 13485:2003 standard is based on ISO 9001:2000, which promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system. However, a 13485:2003 ISO registration is directed for the design, development, production, installation and servicing of medical devices and related services. "That's why we are proud to showcase our PAP-8E Platelet Aggregation Platelet aggregation The clumping together of blood cells, possibly forming a clot. Mentioned in: Herbalism, Traditional Chinese Profiler(R) and related products at the Mayo Clinic's 12th annual Bleeding and Thrombosis Conference in Rochester, Minn. this week," Trolio added. This year the Mayo conference includes a focus on von Willebrand Disease Von Willebrand Disease Definition Von Willebrand disease is caused by a deficiency or an abnormality in a protein called von Willebrand factor and is characterized by prolonged bleeding. . Bio/Data's PAP-8E is a modern laboratory instrument utilized for testing platelet function. Test results provide a vital pathway enabling medical professionals to diagnose various stages of hemostasis disorders, including von Willebrand Disease, hemophilia and Glanzmann's disease Glanzmann's disease thrombasthenia. Glanzmann's disease Glanzmann's thrombasthenia Hematology An AR inborn error of metabolism characterized by coagulation defects Clinical Epistaxis, bruising, excess bleeding Lab ↑ Bleeding time, defective clot , or to monitor the use of antiplatelet drugs like Plavix(R) and aspirin. Other Bio/Data products consist of reagents and disposables to augment a variety of platelet testing. Bio/Data's web address is www.biodatacorp.com. The company's aggregation products are CE marked. |
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