Quality Assurance

Quality

In December 2003, Logical Medical Systems was awarded a Certificate of Approval by Lloyd's Register Quality Assurance, confirming its compliance with the quality management system standards in ISO 9001:2000, ISO 13485:2003 and ISO 13485:1996.

 

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αlpha now 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 13485:2003 Development, distribution, installation, support and maintenance of Antenatal Screening Software.

Approval of conformity certificate: Annex IV of the In Vitro Diagnostic Medical Devices Directive 98/79/EC.

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

ISO 13485:2003 Design, development, control of manufacturing, distribution, installation, support and maintenance of software for Antenatal Risk Evaluation.