About us
Biometrics Ltd E-LINK is a world leader in the design, manufacture and distribution of technologically advanced sensors, instruments and software for the demanding needs in clinical rehabilitation.
E-LINK is the world standard for computerized clinical exercise and evaluation. Originally developed by therapists and engineers in 1993, E-LINK continuously evolves to meet the changing needs of clinicians and patients. It offers a comprehensive range of modules for exercise, evaluation, documentation, progress reporting, and physical impairment calculations. Biometrics Ltd is proud of E-LINK's longevity, with thousands of hospitals worldwide effectively using E-LINK to benefit patients for 10 to 15 years (or longer).
Part of Biometrics Ltd
Biometrics Ltd E-LINK is an integral part of Biometrics Ltd, a company renowned for its innovative solutions in clinical rehabilitation. This connection ensures that E-LINK products benefit from the extensive expertise and resources of Biometrics Ltd, providing unparalleled support and development.
Certificates
ISO 13485:2016, EN ISO 13485:2016Design, development, manufacture, sales, distribution, and service of computerized physiological data capture, evaluation documentation and therapeutic exercise systems.
China SFDA E-LINK CertificateJapan TUV SUD BABT CertificateQuality 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.
Canada Medical Certification
Important: Biometrics Ltd products are NOT sold as medically certified into Canada.