Camarillo, California – ZPower, the world’s only developer of rechargeable, silver-zinc micro-batteries, and the manufacturer of the ZPower Rechargeable System for hearing aids, has met the Medical Device Quality System standard, which recognizes ZPower as a competent supplier of medical devices.
Specifically, the notified body LNE GMED awarded ZPower the following new certifications: ISO 13485:2016, ISO 13485:2003 CMDCAS and the CE Mark for the ZPower Rechargeable System for Hearing Aids. These new certifications recognize ZPower as a medical device manufacturer and are a significant milestone in the global homologation of its rechargeable system for hearing aids, which will enable distribution outside of the United States.
“The level of quality in which we operate is in alignment with the expectations of the medical device industry,” says Damon Mikoy, VP of quality and regulatory affairs, "and with LNE GMED’s certification as evidence of compliance to these standards, we look forward to supplying our innovative and safe silver-zinc battery technology to the medical device marketplace.”
As medical device manufacturers strive to meet manufacturing, shipping and environmental regulations pertaining to the type of batteries utilized in tomorrow’s products, ZPower is uniquely positioned to offer an energy solution that meets all necessary requirements as well as design solutions.
About ZPower LLC
ZPower is a leader in the development of rechargeable, silver-zinc batteries for miniature battery applications whose headquarters and manufacturing facility is in Camarillo, Calif. The company provides a total solution for hearing instrument manufacturers which includes advanced silver-zinc battery technology and charger design support. The ZPower solution simplifies new product development and speeds time-to-market. For end users, ZPower batteries deliver unmatched performance, improved user experience and are better for the environment. ZPower is ISO13485:2016 and ISOISO 9001:2008 certified and its facility and devices registered with the FDA.