Yes. GOQii Smart Vital is ISO certified under the following grades:
ISO 9001 standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in ISO’s quality management principles. Using ISO 9001 helps ensure that customers get consistent, good-quality products and services, which in turn brings many business benefits.
ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
ISO 27001 is widely known, providing requirements for an information security management system (ISMS), though there are more than a dozen standards in the ISO/IEC 27000 family. Using them enables organizations of any kind to manage the security of assets such as financial information, intellectual property, employee details or information entrusted by third parties.
ISO 27799 certifies that the healthcare organization and other custodians of health information ensure a requisite level of security and maintain confidentiality, integrity and availability of personal health information in their care.
Yes. GOQii Smart Vital is approved as a registered medical device by the Central Drugs and Standard Control Organization (CDSCO) (GOQii-MUMBA-MH/M/MD/001104).