Allied receives ISO certification for CardioCel
Allied Healthcare (ASX:AHZ) has received ISO 13485 certification for regenerative therapy CardioCel, bringing it a step closer to European CE Mark approval.
Allied Healthcare (ASX:AHZ) is a step closer to European CE Mark approval for CardioCel, its regenerative therapy for congenital heart defects, after being granted ISO 13485 certification.
The certification covers quality assurance and is an important step in being granted CE Marking, which is a legal requirement for medical devices intended for sale in Europe.
In order to qualify for ISO 13485, Allied had to implement a quality management system that conformed to ISO standards. The company also underwent a Quality Management System audit by the Therapeutic Goods Administration as part of the Conformity Assessment Review of CardioCel.
The ISO certification will also assist Allied in obtaining a Health Canada Medical Device License, said Lee Rodne, Allied Healthcare Group Managing Director.
CardioCel is currently available in Australia under the Authorised Prescriber Scheme.
A recent joint study done with CSIRO found CardioCel tissue patches offer superior survival and growth for stem cells compared to the gold-standard tissues now in surgical use.
A study published last year also found CardioCel aids in heart valve reconstruction.
Allied Healthcare (ASX:AHZ) was trading level at 2.6c as of around 1.40 pm on Wednesday.
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