Tunstall’s community alarm and telecare products are CE marked, as are its medical device products, including icp triagemanager software, myclinic and mymedic.
CE Marking is a European mark of conformity that indicates a product complies with the essential requirements of the applicable European laws or directives with respect to safety, health, environment and consumer protection.
Tunstall’s mymedic, myclinic and icp triagemanager software are compliant with the essential requirements of the Medical Devices Directive 93/42/EEC and classified as Class 1 medical devices.
Tunstall’s telehealth development and manufacturing processes are certified as conforming to ISO 13485, the quality management system for medical devices. Tunstall also adheres to ISO 14971 (Application of Risk Management to Medical Devices), which underpins risk management in Tunstall telehealth hardware and software design and manufacture.
Tunstall is certified as compliant with ISO9001 for the Design, Manufacture, Installation, Service and repair of emergency alarm systems for the elderly and infirm, and the maintenance of fire detection and fire alarm systems.
Tunstall is certified as compliant with ISO14001 for the Design, Manufacture, Installation, Service and repair of emergency alarm systems for the elderly and infirm, and the maintenance of fire detection and fire alarm systems.
ISO 14001 is an internationally accepted environmental standard that helps companies to comply with environmental laws and standards, minimising any adverse effects of their business on the environment and putting in place an effective Environmental Management System (EMS) in order to monitor and continually improve performance.
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Tunstall’s telehealth IT services are certified as conforming to ISO/IEC 20000 (the international service management standard for IT services) is which specifies requirement for the provider to plan, establish, implement, operate, monitor, review, maintain and improve an SMS. This demonstrates the highest level of best practice within Tunstall for the delivery of managed telehealth services using its integrated care platform suite of software.
Tunstall’s telehealth IT services are certified as conforming to ISO/IEC 27001, the international information security management system standard.
This demonstrates that Tunstall's processes take appropriate preventative measures to protect the data it holds on behalf of its telehealth customers, and demonstrates to customers that the business has an appropriate infrastructure in place to ensure the security of information in its care.
Tunstall products and services are also certified to relevant Product Standards; please refer to the relevant product datasheet for further information.
Both Tunstall Healthcare (UK) Ltd and Tunstall Response are members of the TSA, the industry body for telecare and telehealth.
Tunstall Response has achieved Platinum level status for monitoring, demonstrating that it works to the very highest standards in the provision of telecare monitoring services.