Premaitha’s quality management system has been assessed and approved as applicable to the design, development and manufacture of in vitro diagnostic reagents and associated software for non-invasive assessment of genetic abnormalities. Premaitha is ISO 13485:2003 certified and operates to a quality management system which is in compliance with the EC In Vitro Diagnostic Medical Device Directive (98/79/EC).
The Company has been audited against the requirements of Annex IV of the In Vitro Diagnostic Medical Device Directive (98/79/EC) and recommended by Notified Body UL International for an EC certificate demonstrating full quality assurance system approval.
The manufacturers of all in vitro diagnostic products for sale in Europe must ensure that their products meet the requirements laid out in the European In Vitro Diagnostic Medical Devices Directive (98/79/EC). For the purpose of affixing a CE mark, the IONA® test has been developed to meet the ‘essential requirements’ specified in Annex I of the Directive and has followed the conformity assessment route of full quality assurance system certification and review of the design dossier by a Notified Body in line with the IONA® test’s classification under Annex II list B of the Directive. The IONA® test received its CE mark in February 2015.
Premaitha’s new NIPT clinical service laboratory is Care Quality Commission (CQC) registered. CQC is an independent regulator of health and social care in England.
The clinical laboratory service is based on Manchester Science Park and its function is to allow new customers to provide pregnant women with access to the IONA® test as soon as possible, whilst their own lab is being established. Premaitha will offer an interim screening facility to which blood samples can be sent. The service laboratory will also provide an important back-up option for customers during busy periods, ensuring results are delivered to healthcare professionals on-time and from a regulated and trusted clinical laboratory.