PROSURG, Inc. Awarded ISO 13485:2003 Quality System upgrade certification.
San Jose, California, April 28, 2006- PROSURG, Inc. announced today that its medical device manufacturing facility located in Silicon Valley California has been awarded ISO 13485:2003 Qulaity System upgrade certification. Prosurg, Inc joins the ranks of internationally renowned medical device manufacturers who have obtained ISO 13485:2003 quality system certificates. ISO 13485:2003 specifies quality management system requirements for an organization to demonstrate its ability to consistently provide products and services at the highest level of quality. The ISO 13485:2003 certificate is a mandatory requirement to demonstrate compliance with appropriate medical device regulatory and statutory requirements for CE-marking in the European Union and CAMDCAS for Canadian approval. Prosurg has already received CE Mark approval for family of products including TURP RF electrodes , TURBT Electrodes for resection, coagulation and vaporization of enlarged prostste, BPH & Bladder tumor resection treatments. Prosurg Inc has also received CE Mark approval for InjecTx, GelTx and other Injection system for controlled tissue ablation of Prostate, Bladder, Uterine Fibroids, breast fibroadenomas and Endometrial Gel ablation.
Ashvin Desai, CEO and President stated, "Prosurg is committed to patient safety and customer satisfaction. We stand behind our Qulaity policy that all of our products and services provided to our customers shall be safe and effective for their intended use. Meeting these Qulaity standards, especially ISO 13485:2003 , means that PROSURG has achieved the highest level of compliance possible for a world-class manufacturing company. For medical devices, CE mark is awarded only to those companies which both satisfy the rigorous standards of ISO 13485 :2003 and comply with the European Union's Medical Device Directive ( MDD) ". Desai continued: "The issuance of the Quality System Certificates of Compliance is the culmination of more than a year's hard work by all of PROSURG"s employees. We are proud of the tremendous efforts made by our employees in bringing this process to a successful conclusion".
PROSURG, Inc. designs, manufactures, and markets single use products for management of urological and gynecological disorders. these products are based on safe and proven R.F. and injection based technology platform to provide cost effective solution for physicians, patients, and health care providers. PROSURG, Inc. currently markets a full line of electrovaporization electrodes for BPH/TURP prostate surgery, and Bladder tumor resection including the SingleBar™, DoubleBar™, RollerLoop™, V+Loop™, CuttingLoop™, Salinetrode™- saline friendly cutting loops and vaporization roller electrodes, which are compatible with commercially available R.F. generators and endoscopic surgical instrumentation. This family of products is available through distributor network on a worldwide basis.Recently, Prosurg has introduced family of new products based on injection technology platform, Injectx, Injectx Flex, GelTx, GelTx Flex, NeoScope & others.Prosurg, Inc is dedicated to develop, manufacture and market innovative products based on the state of the art technology for treatment of Urological, Uro-Gynecological & gynecological diseases and disorders. Prosurg inc is committed to provide cost effective treatment options for men's and women's health. For additional information, please visit www.Prosurg.com