Medibio Announces ISO 13485 Certification

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 desires 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 acknowledged globally as a universal measure of quality and is a critical prerequisite to make safe CE Mark and other regulatory certifications.

“This is a 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 brilliance.”

Following receipt of ISO certification, Medibio reaffirms its expectation of gaining CE Mark shortly.