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.