Skyline Medical Receives ISO 13485 Certification for STREAMWAY® System

 Skyline Medical Inc..producer of the FDA-approved STREAMWAY System for automated, direct-to-drain medical fluid disposal, announces that it has received ISO 13485:2016 certification for its STREAMWAY System.

    ISO certification is an internationally recognized quality standard for medical devices that is awarded when an organization demonstrates its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services, and is a requirement for medical device clearance in Canada, the EU and a majority of other countries that require products meet EU safety, health and environmental requirements.

   Skyline Medical Inc. produces a fully automated, patented, FDA-cleared, waste fluid disposal system that virtually eliminates staff exposure to blood, irrigation fluid and other potentially infectious fluids found in the healthcare environment. Antiquated manual fluid handling methods — which require hand carrying and emptying filled fluid canisters — present an exposure risk and potential liability.

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