ISO (International Organization for Standardization) is an independent, non-governmental international organization. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges. ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
"Eclipse is proud of this significant achievement of obtaining ISO 13485 certification from BSI, an internationally recognized and respected registrar," said Shawn Beddes, Director of Quality and Regulatory Assurance for Eclipse. "This milestone further demonstrates Eclipse's commitment to providing the best quality and innovative products to our customers in a heavily regulated environment."
ISO 13485 certification with BSI, a premier notified body, is key in the continued expansion of Eclipse into the worldwide market. ISO 13485:2003 certification is a strategic element that allows the company to meet the growing global demands for top-selling products including Eclipse PRP®, platelet-rich plasma kits and the soon-to-be introduced Eclipse MicroPen® family of award-winning micro-needling devices.
Eclipse Aesthetics®, LLC. provides superior products to the U.S. and International aesthetic and medical communities. The company has a number of offerings including: Eclipse PRP® kits, a portfolio of Eclipse MicroPen® products and a growing line of high-quality, physician-grade skin care. For additional information, please visit: www.EclipseMed.com or www.EclipseIntl.com.
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SOURCE Eclipse Aesthetics, LLC