ivWatch ISO 13485 certification opens the door for international distribution
By Sandra J. Pennecke
Aug 28, 2017, 5:00 PM EST
ivWatch, LLC has achieved a certification that will allow it to reach even further in its efforts to help hospitals improve the safety and effectiveness of intravenous therapy.
The Hampton-based medical device manufacturing company, which was founded in 2010, created a technology that helps clinicians manage the risks associated with IV therapy through early detection.
In mid-August, it achieved its International Organization for Standardization – ISO 13485 certification – which is the global standard for medical device quality management systems.
ivWatch completed a pre-assessment readiness review and a four-day audit to earn the certification.
The certification will allow ivWatch to open up international distribution for its ivWatch Model 400, aimed at helping eradicate injury to patients by monitoring for evidence of infiltration and the ivWatch OEM Board, a technology that incorporates ivWatch into existing products.
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