Quality Management System

Biometrics Ltd maintains to the highest standard a Quality Management System that is independently accredited to ISO 13485:2016 and EN ISO 13485:2016. The Quality Management system has been in continuous operation for over 10 years and is independently audited by SGS on an annual basis. The scopes of the certifications include: Design, development, manufacture, sales, installation and service of computerized physiological data capture, evaluation documentation and exercise systems.

Medical Device Certifications (outside Europe)

Various Biometrics Ltd products are listed with numerous international medical device regulatory agencies including the United States of America Food and Drug Administration, Health Canada, China SFDA, and the Taiwanese Ministry of Health & Welfare. As such, in addition to non-medical applications, they are considered medical devices intended for medical measurement purposes or for use in the treatment and diagnosis of disease.

European Medical Device Certifications

Biometrics Ltd E-LINK systems (sensors and instruments) are CE marked as medical devices in Europe – all current systems are independently certified to Safety Standard of the International Electrotechnical Commission IEC 60601-1:2005 + A1:2012 and BS EN 60601-1:2006 + A1:2013, conforming to the European Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC, conforming to the council Directive relating to Electromagnetic Compatibility by the application of BS EN 60601-1-2.

Biometrics Ltd manufactures variations of DataLITE, DataLOG and DataLINK (sensors and instruments) for Data Acquisition which are CE marked medical devices in Europe, independently certified to Safety Standard of the International Electrotechnical Commission IEC 60601-1:2005 + A1:2012 and BS EN 60601-1:2006 + A1:2013, conforming to the European Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC, conforming to the council Directive relating to Electromagnetic Compatibility by the application of BS EN 60601-1-2. Other variations are available as non medical devices.

Biometrics Ltd K800 Amplifier for Data Acquisition, Movement analysis and EMG used in Research Environments (sensors and instruments) is independently certified to Safety Standard of the International Electrotechnical Commission IEC 60601-1:1988 including Amendments 1 & 2, EN 60601-1:1990 including Amendments A1, A2 & A13, BS 5724-1:1989 including Amendments 1, 2 & 3 and conform to the council Directive relating to Electromagnetic Compatibility by the application of BS EN 60601-1-2. However, in Europe, as the K800 Amplifier does not conform to the European Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC. It is not considered a medical device and is not for medical measurement purposes, or for use in the treatment and diagnosis of disease.

ISO 13485:2016
EN ISO 13485:2016

Design, development, manufacture, sales, installation and service of computerized physiological data capture, evaluation documentation and exercise systems.

ISO 13485:2003 (Health Canada)
Design, development, manufacture and service of computerized physiological data capture, evaluation documentation and exercise systems for use in biomedical research and in biomechanics and movement analysis in rehabilitation.

Directive 93/42/EEC

China SFDA E-LINK Certificates