Quality Assurance

Quality

Logical Medical Systems has been awarded a Certificate of Approval by Lloyd's Register Quality Assurance, confirming its compliance with the quality management system standard ISO 13485:2016

αlpha carries a CE mark, in accordance with the requirements of the European Directive on in-vitro medical devices (Directive 98/79/EC) and the UK Medical Device Regulations 2002:618.

Logical Medical Systems has also been approved for the development, distribution, installation, support and maintenance of software for antenatal risk evaluation under the relevant requirements of the Canadian Medical Devices Regulations.

Certificates

ISO 13485:2016 Development, distribution, installation, support and maintenance of Antenatal Screening Software.

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, control of manufacturing, distribution, installation, support and maintenance of software for Antenatal Risk Evaluation.