Q-Health
Health app validation
SQS has extensive experience in validation and verification of medical devices and, on the other hand, also in the certification of mobile applications for different sectors of activity (Q-Mobile)
As a result of this experience and the growing need observed in the market for new and innovative solutions that are correctly validated and certified for mHealth (use of mobile technology to manage people’s health and well-being), SQS strengthened its mobile devices V&V service with the creation of the Q-Health platform.
Relying on this platform we gain in efficiency, speed to respond to a market with increasingly immediate demands and proximity to the client since it offers access to information remotely as it is a web platform.
In addition, the Q-Health platform serves as a support for approval against different safety standards.
Q-Health goal
The Q-Health platform, developed by SQS, is designed to manage all the activities included in the Medical Device V&V Plan. It allows categorizing the device according to its level of criticism, preparing the plan that responds to its regulatory requirements, carrying out a risk analysis of an application, as well as managing the different review and testing activities included in the corresponding Plan. It also includes results report options.
A particularity of the Q-Health platform is that it includes and maintains a benchmark test protocol that covers aspects of usability, navigability, accessibility and security of mobile applications for health. This test suite is based on and aligned with various quality, safety and regulatory standards. In this way, Q-Health is the tool that SQS uses as an important support when it comes to approaching a medical device validation process effectively and completely.
Certifications
UNE-EN ISO/IEC 17025
ISO 9001
ISO 20000
ISO/IEC 27001
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