SEOUL, South Korea, Feb. 27, 2018 /PRNewswire/ -- Mobile healthcare startup, BBB Inc.(CEO, Jaekyu Choi), announced that it acquired ISO 13485 Certification (a quality management system standard for medical devices).
ISO 13485 is an international standard that delineates the requirements for a quality management system in the medical device industry. To meet the criteria, businesses are required to ensure a consistent quality management system from production to customer relations.
Earning the qualification is a big step forward for BBB and elemark™, its flagship product, in expanding its sales into international markets.
"BBB's smart IVD (in vitro diagnostics) device has cleared the tall barrier to entry of the European market. Taking this opportunity, we'll enter Europe with international partners with whom we have been in negotiations," said CEO Jaekyu Choi.
After having recently commercialized the world's first power-free plasma isolation technology, BBB is now focusing on the development of a new product that uses AI to gather and analyze blood biomarkers to provide cancer diagnoses from a single drop of blood. The product is scheduled for release in 2019 in both professional and self-test versions and is currently undergoing clinical trials.
BBB is a Korean mobile healthcare startup founded in Oct 2014. The company develops and sells elemark™, an Android-based blood testing device that enables personalized blood tests and biomarker monitoring. Its purview spans the U.S.A., France, South Africa, China, Malaysia, and the U.A.E., among others. with local partners in R&D, production, and sales. After introducing elemark™ dual check to the market in Nov 2017, BBB is developing various other IVD solutions such as a cholesterol testing device and lab-on-a-chip technology for cancer diagnosis and prognosis management.
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SOURCE BBB Inc.