sitem-insel AG

June 30, 2020

Decomplix supports FOPH with SwissCovid App

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Our community member Decomplix, located within sitem-insel AG, supports the BAG/FOPH with the SwissCovid App. Read more about it here.
 


With the SwissCovid app, everyone can help contain the spread of the new coronavirus. Thanks to correct behavior, users can interrupt chains of infection and protect others. The app informs users if they have been potentially exposed to the coronavirus. If Bluetooth is turned on, the app automatically detects when two users are close together for a period of time, and anonymously exchanges random IDs.

The app is a medical device and therefore requires technical documentation that proves the safety and performance of the software. It must comply with the legal requirements and applicable standards and be notified to Swissmedic, the competent authority.

The Federal Office of Public Health (FOPH) has therefore entrusted Decomplix with the following tasks:

  • Creation of the technical documentation of SwissCovid according to the requirements of the EU Directive 93/42/EEC (MDD).
  • Preparation for the notification to Swissmedic of SwissCovid as a Class I medical device (MedDO, SR 812.213).
  • Advising the FOPH on the definition and implementation of the necessary processes to ensure safety and quality.
  • Support in maintaining compliance and in issues relating to the regulation of medical devices.

We recommend using the SwissCovid app. The more people who install and use the app, the more effectively the app can help to contain the new coronavirus. Download from the app stores:

For more information on coronavirus, the SwissCovid app and contact tracing, visit the FOPH website.

 

For questions: 
Beni Hirt, CEO, 079 668 02 60

Source: Decomplix