REGULATORY

 

The techniques for exploring and measuring biomarkers can vary. Countries also have different regulatory processes to obtain approval to sell their product. 

Qlife is ISO 13485:2016 certified

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.​

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.

  

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EGOO.HEALTH

Borupvang 3

DK-2750 Ballerup

Denmark

CVR 39982277

info@egoo.health