REGULATORY

 

The techniques for exploring and measuring genetic biomarkers can vary. There is also a specific regulatory process in each country that manufacturers must get through before gaining approval to sell their product

in the country or region.

Currently Qlife has obtained the following certifications:

  • EN ISO 13485:2016 specifies requirements for a Quality Management System where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

  • CE-Marking for professional use for Hb/CRP capsule. For other capsules, see the respective timelines within each field

  • CE-Marking for sub-test (self-test) – in process. See the respective timelines within each field

 

Qlife adheres to the ethical and privacy practices described in The European Charter of Fundamental Rights. It also complies with GDPR and the EU IVD regulations for self-testing.

Please contact us if you have any questions about our regulatory affairs.

  

0

EGOO.HEALTH

Borupvang 3

DK-2750 Ballerup

Denmark

CVR 39982277

info@egoo.health