LONDON (ShareCast) - (ShareCast News) - Personalised mobile health development company Concepta announced on Monday that it has achieved ISO13485 accreditation, which it says is a key step in attaining its CE marking for its 'myLotus' product for unexplained infertility, ahead of a commercial launch in the UK and Europe in the second half of 2017.
The AIM-traded firm said ISO13485 certification is an endorsement of the Quality Management System that underpins its position as a manufacturer of medical devices.

It said the accreditation is recognised on an international scale, and is a critical part of gaining regulatory approval for Concepta's myLotus to be sold in the European Union.

"This is a proud moment for the Concepta team and importantly a crucial development towards the launch of our flagship myLotus fertility product into the UK and European markets, where the potential market opportunity is circa £350m," said Concepta CEO Erik Henau.

"It cannot be underestimated how much work goes into documenting the procedures of an entire organisation within a QMS system and ensuring that the procedures are followed to the point that they become a seamless part of everyday operations."

Henau asserted the accreditation is a "strong endorsement" of the quality of an organisation at all levels.

"Further to this we are delighted to report that with regulatory approvals and manufacturing agreements already in place in China we remain on track to roll out the myLotus product into the Chinese market in H1 2017."

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