Tangent Medical, creator of the NovaCath™, announced it has been awarded ISO 13485:2003 from the British Standards Institution (BSI). ISO 13485:2003 certification is the internationally recognized quality standard for medical devices and diagnostics.
Online PR News – 16-February-2014 – Ann Arbor, MI – Tangent Medical (www.tangentmedical.com), a manufacturer of IV therapy products and creator of the NovaCath™ Integrated IV Catheter System, announced it has been awarded ISO 13485:2003 from the British Standards Institution (BSI). ISO 13485:2003 certification is the internationally recognized quality standard for medical devices and diagnostics.
Tangent Medical is committed to quality through established and consistent policies, practices, and procedures in the areas of design, manufacturing and distribution of sterile disposable IV therapy products. This certification demonstrates that Tangent meets the highest quality standards in the US and abroad.
“The NovaCath Integrated IV Catheter System was developed after a year of clinical immersion to address many patient and clinician needs, while providing benefits to healthcare facilities and hospitals in the area of safety, compliance and cost-savings,” said Tangent Medical CEO Jeff Williams. “Receiving this ISO 13485 certification marks another significant milestone we’ve achieved in our commercialization efforts. We are committed to the highest quality standards, and are now well positioned to introduce our product into international markets.”
International Organization for Standardization (ISO), the world’s largest developer and publisher of International Standards, is a federation of national standards bodies from 130 countries. The ISO 13485 Quality Management Systems Standard is based on ISO 9001, but it is a Quality Management System standard specifically developed for the manufacture of medical devices.
“NovaCath uniquely integrates several patented design elements that not only reduce the risk of IV complications but also improve healthcare worker safety and clinical efficiency,” said Curtis Bloch, Vice President of Sales & Marketing for Tangent Medical. “Our innovative, award- winning design delivers advanced catheter stabilization, next-generation tubing management, passive needle encapsulation and blood control on every short-peripheral IV start. The clinical feedback from the U.S. market has been exceptional. This ISO certification will enhance our ability to make a positive impact on patient lives, from around the world.”
The NovaCath™ Integrated IV Catheter System integrates a series of next-generation technologies designed to address IV therapy challenges including catheter stabilization, healthcare worker safety, tubing management and patient comfort. NovaCath is the only peripheral IV catheter with advanced catheter stabilization designed to exceed the highest CDC, OSHA and INS standards for IV catheter stabilization. Its passive needle shielding technology and closed system design minimize risk of needlestick injuries and occupational exposure to blood to the lowest feasible extent. Several novel design features uniquely position NovaCath to offer healthcare facilities uncompromising safety and satisfaction – both to the clinician and the patient.
British Standards Institution is currently one of the world’s largest independent certification bodies for management systems. BSI was established in 1901 and was the world’s first national standards body.
About Tangent Medical
Tangent Medical is focused on the development and commercialization of IV therapy products. Founded in 2009, the company's patented NovaCath™ Integrated IV Catheter System is the only safety IV catheter to cost-effectively combine advanced catheter stabilization, passive needle encapsulation, tubing management and blood control. Based on extensive clinical research into the needs of both healthcare workers and patients, this next-generation system is designed to establish a new standard in catheter design, functionality and performance. For more information, visit www.tangentmedical.com.