Leading Medical, Aesthetic Provider Meets Comprehensive Requirements for Quality Management System in Design/Development of Devices for Skin and Orthopedic Applications
Eclipse Aesthetics®, LLC. achieved ISO 13485:2003 certification and the complete implementation of their Quality Management Systems in December 2016.The designation was a significant and transformative step forward for Eclipse as it continued to design, develop and market leading-edge products to customers in the United States, Canada, Europe and across the globe.
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 obtained the ISO 13485 certification from BSI, an internationally recognized and respected registrar. This milestone 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 was a key component 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.