30th Jan 2015 09:31
LONDON (Alliance News) - Premaitha Health PLC said Friday that it has met two key requirements for obtaining a CE Mark for its IONA in-vitro diagnostic product, for which it now expects to receive a CE Mark in February.
The company said it has also achieved an ISO certification, which confirms that its quality management system has been approved, and it has also been recommended a European Commission certificate demonstrating full quality assurance system approval.
This will cover its requirements for placing the IONA test in the European market, the company said. It has made further progress in preparing for a commercial launch, opening a training facility, completing the development of a new warehouse facility and beginning commercial manufacturing.
Shares in Premaitha are trading up 3.6% at 21.50 pence Friday morning.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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