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Quality & Security

Aiforia Technologies holds information security to the highest standard. We hold several, globally relevant quality and security certifications, so you can be sure your sensitive information is safe.
This external validation of quality and security demonstrates Aiforia’s commitment to providing medical software that consistently meets customer needs and regulatory requirements.


Medical devices Quality management ISO 13485:2016

Information security management ISO 27001:2022

Customer data security SOC 2 Type II Report

Customer data security HIPAA Security Rule

ISO 13485:2016

Specifies requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more life-cycle stages, including design and development, production, storage and distribution, installation or servicing of a medical device, and design and development or provision of associated activities (e.g., technical support).

ISO 27001:2022

Specifies the requirements for establishing, implementing, maintaining, and continually improving an information security management system within the context of the organization. It also includes requirements for assessing and treating information security risks tailored to the organization's needs.

SOC 2 Type II Report

An internal controls report that captures how a company safeguards customer data and how well those controls operate. SOC 2 is an auditing measure developed by the American Institute of CPAs (AICPA) that ensures service providers securely manage user data. 

A SOC 2 Type 2 report ensures that a company considers all aspects of the business when evaluating information security, including but not limited to: data processing, development processes, hiring practices, personnel training, new hardening, detection, and prevention methods. 

HIPAA Security Rule

Aiforia has designed and implemented its security practices to comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Additionally, an independent audit firm has evaluated and tested the controls identified by Aiforia for compliance with the HIPAA Security Rule. HIPAA compliance allows Aiforia to offer AI-supported image analysis solutions to a broader range of customers in the US.

HIPAA is a US federal law that protects the privacy and security of individuals' health information in the United States. Compliance with HIPAA requires strict adherence to various security and privacy measures, including administrative, physical, and technical safeguards.

Why the cloud?

A cloud-based platform affords any laboratory with infinitely scalable digital pathology deployment.