Compliances (13)

Here are the compliance frameworks that undefined follows which showcases our adherence to industry-standard security guidelines and practices.

US FDA

Compliant

Augmento obtained US FDA 510(k) clearance in April, 2023 CXR Analyzer obtained 510(k) clearance in October, 2023

CDSCO

Compliant

DeepTek obtained MD-42 Sale & Distribution license Manufacturing License for Genki and Augmento

Kenya Board

Compliant

Genki and Augmento is Kenya Board Certified

Thai FDA

Compliant

Genki obtained Thai FDA Approval in May, 2023

Medical Device Authority Malaysia

Compliant

Augmento and CXR Analyzer received approval from Malaysia MDA

Compliant

Augmento obtained self-declared CE marking as class I SaMD per EU MDR 2017/745

MoH Indonesia

Compliant

Augmento has received approval from Indonesia MoH

Health Science Authority, Singapore

Compliant

Chest X-ray AI solution received approval from Singapore HSA

EU CE MDR

Compliant

Chest X-ray AI solution received CE approval as class IIb SaMD per EU MDR 2017/745

ISO 13485

Compliant

DeepTek's Quality System is EN ISO 13485:2016 certified

ISO 27701

Compliant

ISO 27701 is an extension of ISO 27001 and ISO 27002 for privacy information management. It helps organizations comply with global privacy regulations by providing a framework for managing personal data.

DeepTek's Information Security Management System is ISO 27001:2022 certified

Philippines FDA

Compliant

Philippines FDA Approval For Augmento and Chest X-Ray AI Solution

UK - Ministry of Healthcare Products Regulatory Agency

Compliant

Augmento - Radiology AI deployment platform and CXR AI Solution Registered under UK - Ministry of Healthcare Products Regulatory Agency

Create your own Trust Center | Powered by