ACRA Regulatory Services Pty Ltd
7/ 84 Poinciana Avenue,
Logical Medical Systems has been awarded a Certificate of Approval by the British Standards Institute, confirming its compliance with the quality management system standard ISO 13485:2016
αlpha carries a UKCA mark, in accordance with the requirements of the UK Medical Device Regulations 2002:618.
αlpha carries a CE mark, in accordance with the requirements of the European Directive on in-vitro medical devices (Directive 98/79/EC).
Logical Medical Systems has also been approved for the design, development, production, distribution, installation and servicing of invitro diagnostic software used in the provision of ante-natal screening under the relevant requirements of the Canadian Medical Devices Regulations and Australian Therapeutic Goods (Medical Devices) Regulations,
Approval of conformity certificate: In Vitro Diagnostic Medical Devices Directive 98/79/EC and the Medical Devices Regulations 2002, UK Statutory Instrument 2002 No.618. Annex IV of the In Vitro Diagnostic Medical Devices Directive 98/79/EC
The intended use of the αlpha software is in antenatal screening and is to assess the risk of the fetus being affected with trisomy 21, 18, or 13, the presence of neural tube defects, or the mother being affected with pre-eclampsia. αlpha should only be used by operators who have received training in its use and is intended for use by healthcare professionals.