Certification represents another key milestone for the company that created the Phoenix ICON™ retinal imaging platform
Pleasanton, CA, USA, May 1, 2019– Today, Phoenix Technology Group, LLC (Phoenix), a leading provider of advanced ophthalmic imaging solutions for researchers and clinicians, announced the company received ISO 13485:2016 certification for Medical Device and Quality Management Systems. This certification is a requirement for regulatory purposes and is an international standard that outlines the requirements for a quality management system specific to the medical devices industry.
ISO 13485:2016 is an internationally recognized quality standard that ensures the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes. To be certified, organizations must demonstrate the ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
“ISO 13485:2016 is the best internationally recognized model to demonstrate that Phoenix has successfully complied with the laws and regulations of the medical devices industry,” said Christopher Henderson, Director, Quality and Regulatory for Phoenix. “This certification represents another key milestone for our company and reflects the focus we have on risk-based decision making throughout our organization with a commitment to safety and providing a high-quality product.”
The patented Phoenix ICON™ platform is a wide-angle, hand-held retinal imaging system employs reinvented optics and was designed without constraints of legacy products, to deliver stunning high-resolution and high-contrast retinal images– even on darkly pigmented retinas.
“Successful innovation is only as good as the quality management system created to deliver on the promise to customers,” said Scott Carr, CEO of Phoenix. “This certification demonstrates our strong commitment to quality and enables Phoenix to continue to develop and deliver retinal imaging technology in compliance with the highest standards for safety, product performance and reliability,” said Scott Carr, CEO of Phoenix Technology Group.”
About Phoenix Technology Group: Phoenix Technology Group empowers people to see: we empower researchers to see more in their fight to prevent blindness; we empower clinicians to see more in their fight to save sight (and lives). We do that by providing clinicians and researchers around the world with stunning retinal images, coupled with timely and accurate data about the retina and the eye. Founded by Bert Massie, Ph.D., inventor of the first digital camera for pediatric retinal imaging, our company created the Phoenix MICRON platform for in-vivo imaging of animals in eye research. Phoenix MICRON is the standard of excellence for researchers worldwide: ten of the top twelve research institutions employ a Phoenix MICRON solution. In 2017, the company launched to great acclaim the Phoenix ICON platform which reinvented wide-field retinal imaging for human clinical applications. Phoenix ICON delivers stunning high-contrast, high-resolution images, with quality you can see and data you can trust. The ICON platform also boasts a number of features including a lighter weight cart and a six-hour battery life. Recognizing that telemedicine is the future of ROP screening, in 2018, Phoenix acquired FocusROP, the most widely adopted telemedicine platform for ROP screening. With this acquisition, retinal images from any wide-field retinal imaging camera can, in seconds, be delivered to physicians when and where they are needed, saving them time while providing better documentation.
Contact: Jen King, Phoenix Technology Group, ph.1.925.485.1100 x 244, firstname.lastname@example.org