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 15 years and is independently audited by SGS on an annual basis. The scopes of the certifications include: Design, development, manufacture, sales, distribution, and service of computerized physiological data capture, evaluation documentation and therapeutic 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, 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 Devices Regulation 2017/745, conforming to the council Directive relating to Electromagnetic Compatibility by the application of BS EN 60601-1-2.
Biometrics Ltd manufactures variations of DataLITE*1, 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 Devices Regulation 2017/745, 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 Devices Regulation 2017/745. It is not considered a medical device and is not for medical measurement purposes, or for use in the treatment and diagnosis of disease.
Japanese ARIB Certification
Biometrics Ltd DataLITE*2 products have been independently tested and certified to the standards of ARIB STD-T66: 3.7 (2014-10) (Association of Radio Industries and Businesses).
Canada Medical Certification
Important: Biometrics Ltd products are NOT sold as medically certified into Canada.
*1 PIONEER is medically certified, ADVANCE and EXPLORE are not
*2 PIONEER and ADVANCE are not medically certified
ISO 13485:2016, EN ISO 13485:2016
Design, development, manufacture, sales, distribution, and service of computerized physiological data capture, evaluation documentation and therapeutic exercise systems.