Regulatory compliance

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Regulatory compliance

How do you know that the app you have downloaded really does what it claims?

And the number of diabetes-related apps is growing constantly. But very few have the stamp of approval associated with the recognizable CE mark.

Triabetes, a diabetes app with a CE mark (type 1 or type 2 diabetes).
Triabetes is CE-marked.

This is because the team at Diabetes Tools (the company behind Triabetes) takes patient safety seriously. Since Triabetes tracks blood sugar levels and medicine intake amongst other parameters to moderate a disease, we follow strict medical device regulations.

As a company, we:

  • hold an ISO 13485 certificate issued by the British Standards Institution (BSI) which means we have the rigorous quality management system in place required for the design and distribution of medical devices.
  • comply with the European Medical Device Directive (93/42 EEC).

This means we can display the CE mark on our products.