SYDNEY, Australia and MINNEAPOLIS, Jan. 10, 2018 (GLOBE NEWSWIRE) -- Medibio Limited (MEB or the Company) (ASX:MEB) (OTCQB:MDBIF) has received a Certificate of Compliance certifying that the Company’s Quality Management System complies with the requirements of ISO 13485. This also includes conformance with the Canadian Medical Device Conformity Assessment System (CMDCAS).
The certification was issued by DQS Med, the Notified Body appointed to assess Medibio’s submission for CE Mark. It signifies that Medibio has established a comprehensive quality system for the design and manufacturing of medical devices. ISO 13485 is recognized internationally as a universal measure of quality and is a critical prerequisite to securing CE Mark and other regulatory certifications.
“This is an major milestone for the Company,” said Medibio’s CEO & Managing Director, Mr. Jack Cosentino. “This accomplishment reflects the work of all individuals within the organization who all believe that this achievement of ISO certification echoes Medibio’s commitment to the highest level of quality management and to operational and production excellence.”
Following receipt of ISO certification, Medibio reaffirms its expectation of gaining CE Mark shortly.
About Medibio Limited
Medibio (ASX:MEB) (OTCQB:MDBIF) is a mental health technology company that has pioneered the use of objective biometrics to assist in the screening, diagnosing, monitoring and management of depression and other mental health conditions. The company was founded in Australia, with offices located in Melbourne (Vic), and U.S. offices in Minneapolis, MN. Medibio is listed on the Australian Securities Exchange Ltd and trades on the OTCQB Venture Market. Investors can find additional information on www.otcmarkets.com and www.asx.com.au.