Eclipse Receives ISO 13485:2003 Certification
Leading Medical, Aesthetic Provider Meets Comprehensive Requirements for Quality Management System in Design/Development of Devices for Skin and Orthopedic Applications
Eclipse Aesthetics®, LLC., a leading manufacturer of medical supplies, is proud to announce the company has achieved ISO 13485:2003 certification and the complete implementation of their Quality Management Systems.
“This designation is a significant and transformative step forward as Eclipse continues to design, develop and market leading-edge products to customers in the United States, Canada, Europe and across the globe,” said Tom O’Brien, Founder and CEO of Eclipse. “Our team has worked tirelessly to implement additional quality control measures to not only quickly achieve this milestone, but to further enhance superior service and products for our customers.”
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 global marketplace. ISO 13485:2003 certificationis 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 solutions to the U.S. and International aesthetic and medical communities. The company offers a portfolio of products including: Eclipse PRP®; Eclipse MicroPen® Elite, and Eclipse Skinfinity RF™, among others. For additional information, contact your representative or Eclipse Customer Care at 800-759-6876.