TOILET MOUNTED URINALYSIS SENSOR NOW ISO 13485 CERTIFIED AS REQUIREMENT FOR UPCOMING CE REGISTRATION
Home-based urinalysis innovator, Olive Diagnostics, confirms ISO 13485 certification and puts European market launch clear in its sights.
JERUSALEM, ISRAEL, December 9, 2021 /EINPresswire.com/ -- Olive Diagnostics, developer of the world’s first optical sensor for passive and seamless urinalysis technology has completed ISO 13485 certification.This significant milestone of certification represents a crucial step in the company's regulatory strategy and brings immense reward.
The ISO 13485 for Accredited Medical Devices and Quality Management Systems (QMS) means Olive Diagnostics has demonstrated building the foundation to provide medical devices and related services that will consistently meet customer and regulatory requirements. The Olive team worked diligently, and through its quality design, manufacturing, components and development, the innovative new urinalysis device will change lives and revolutionize early disease detection one drop at a time.
This life altering technology becomes the foundation for the early detection of a multitude of health inhibitors and life-threatening conditions that can be detected in urine. In real-time, users are enabled to leverage the ample health data flowing out of their bodies to better detect and manage illness. The Olive Diagnostics team is excited to soon see the Olive KG device initially hit European elder care homes and women’s health clinics in Q1 2022, with unprecedented potential for expansion throughout Aged-Care systems and individual homes around the world.
About Olive Diagnostics
Olive Diagnostics has developed the world’s first 100% passive, non-invasive urinalysis sensor that seamlessly analyses data in real-time. Its flagship device, the Olive KG, attaches easily to any toilet and analyzes the urine stream by combining advanced spectroscopy and AI. Olive Diagnostics enables users to leverage the ample health data from biomarkers flowing out of their bodies to better detect and manage their health.
Danny Brill
Olive Diagnostics
+972 54-598-0793
uriNation@olive.earth
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