Quality Management System

Biometrics Ltd maintains to the highest standard a Quality Management System that is independently accredited to ISO 9001:2008, ISO 13485:2003 and EN ISO 13485:2012. 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, supply, test and service of electromechanical displacement transducers, amplifiers, electronic data recorders and data capture, display and analysis software (ISO 9001) and Design Development, manufacture, supply, installation and service of computerized physiological data capture, evaluation documentation and exercise systems (ISO 13485).

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 DataLOG and DataLINK (sensors and instruments) for Data Acquisition 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.

Biometrics Ltd K800 Amplifier for Data Acquisition, Movement analysis and EMG used in Research Environments (sensors and instruments) are 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, they are not considered medical devices and are not for medical measurement purposes or for use in the treatment and diagnosis of disease.

DataLITE Wireless Sensors and Systems

DataLITE is designed and manufactured in compliance with the International Standard Quality management systems - Requirements ISO9001, as part of the Biometrics Ltd Quality Management System. The DataLITE products are not yet classified as medical devices and are not for medical measurement purposes or for use in the treatment and diagnosis of disease.

View Certificates

ISO 9001:2008
Design, development, manufacture, supply, test and service of electromechanical displacement transducers, amplifiers, electronic data recorders and data capture, display and analysis software.

ISO 13485:2003, EN ISO 13485:2012
Design Development, manufacture, supply, 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