ivWatch Achieves ISO 13485 Certification: Provides Foundation For International Distribution
Published: Aug 15, 2017
HAMPTON, Va., Aug. 15 2017 /PRNewswire/ -- ivWatch LLC, a medical device company focused on improving the safety and effectiveness of intravenous (IV) therapy, today announced receipt of its ISO 13485 Certification, the global standard for medical device quality management systems (QMS) developed by the International Organization for Standardization (ISO®).
"This is an important milestone for ivWatch, as it validates our commitment to quality and verifies the high standards we follow in the design, development, and manufacturing of the new ivWatch OEM Board and FDA-cleared ivWatch Model 400," says Mike Gahan, vice president of operations at ivWatch. "Obtaining this ISO certification firmly establishes our solid foundation for future growth and we look forward to bringing better, safer IV procedures to more hospitals across the U.S. and around the world."
To achieve this important certification, ivWatch demonstrated that all of its activities and processes conform to both the ISO® standard and the current good manufacturing practices required by international medical device regulations. The company completed a pre-assessment readiness review, followed by a thorough four-day, stage two audit, conducted by TÜV SÜD, an accredited and internationally-recognized certification body. ivWatch passed this comprehensive stage two audit with zero (0) findings; a major accomplishment for any medical device company.
ivWatch is the leader in developing, commercializing and distributing non-invasive sensor technology to monitor a patient's IV site for complications. The ivWatch Model 400 is an FDA-cleared stand-alone continuous monitoring system that allows clinicians to manage the risk of IVs by providing early detection of infiltration and extravasation. The ivWatch technology is also available to OEMs for integration into existing infusion and patient monitoring products. Reliable early detection of infiltrations and extravasations is a requirement to help hospitals manage the risks associated with this common invasive procedure.
The International Organization for Standardization is the world's largest developer and publisher of international standards for the implementation of quality management systems. EN ISO 13485:2012 + AC:2012 certifies that the ivWatch QMS aligns with the requirements of the Canadian Medical Device Regulations (CMDR), the European Union's Medical Device Directive (MDD) and other regulatory requirements found throughout the world.
ivWatch LLC is a medical device manufacturer focused on improving patient safety and the effectiveness of intravenous therapy. ivWatch provides a first-of-its-kind, FDA-cleared, noninvasive medical device that continuously monitors peripheral IVs for infiltration and extravasation events. The ivWatch Model 400 aims to help eliminate patient harm associated with adverse events and to reduce drug delivery errors. The ivWatch OEM Board integrates ivWatch technology into existing products, enabling OEMs to help healthcare providers deliver a higher level of patient care and to reduce risks related to IV therapy. The ivWatch OEM Board is not an FDA-cleared device. It is the responsibility of the Original Equipment Manufacturer integrating ivWatch technology to secure the proper regulatory clearance. Follow us on Twitter@ivWatch or Facebook @ivWatchLLC. www.ivWatch.com
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SOURCE ivWatch, LLC