Quality Assurance

Quality

 

Australian sponsor:
ACRA Regulatory Services Pty Ltd
7/ 84 Poinciana Avenue,
Tewantin QLD
Australia 4565

 

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,

Certificates

ISO 13485:2016 Design, development, production, distribution, installation and servicing of Antenatal Screening Software.

Approval of conformity certificate: Medical Devices Regulations 2002, UK Statutory Instrument 2002 No.618

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

ISO 13485:2016 Design, development, production, distribution, installation and servicing of invitro diagnostic software used in the provision of ante-natal screening

Intended Use

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.

Instructions for Use

Users in the European Union with a current Alpha licence may access copies of the Alpha Instructions for Use (IFU) from this website by clicking here .