Regulatory Compliance

Our products are designed to meet the highest standards of medical device compliance, ensuring safety, reliability, and seamless integration across diverse markets. Wherever you are, Infermedica delivers trusted innovation tailored to your needs.

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Medical Device Compliance

Completed

Since 2018, we have been offering our renowned medical-grade products. Our latest software, the Medical Guidance Platform (MGP), together with its modules—Triage, Intake, and Follow-up—is certified as a Class IIb medical device under the EU MDR.

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Security ISO 27001

Completed

We offer proven systems compliant with industry standards, featuring robust security measures and ongoing oversight through regular penetration testing.

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Al Act

In progress

As AI-powered medical devices, Infermedica’s products are classified as high-risk systems under the EU AI Act. Most of the requirements are already fulfilled through our MDR compliance framework. As the enforcement guidelines continue to evolve, we closely monitor regulatory developments and stand ready to adapt whenever necessary.

Medical Device Compliance

Completed

Infermedica’s software operates under FDA enforcement discretion due to its clear Intended Use: guiding users via symptom questionnaires to recommend appropriate care settings. This ensures compliance with best practices in safety, usability, and transparency, without requiring FDA clearance.

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SOC 2

Completed

Our systems are designed with robust data protection measures, ensuring compliance with industry standards. We adhere to SOC 2 security principles, implementing strict access controls, encryption, and continuous monitoring to safeguard sensitive information.

HIPAA

Completed

Infermedica designs its healthcare solutions with robust security—encryption, access controls, and audit logs—to safeguard Protected Health Information. By complying with HIPAA, we ensure our AI-powered tools uphold top standards for privacy, security, and confidentiality.

Medical Device Compliance

In progress

Infermedica is actively assessing TGA regulatory pathways and potential registration routes. For now, clients must handle TGA registration. Once we obtain EU MDR certification, we’ll apply for MGP registration in Australia, with plans to start this process in late 2025.

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Medical Device Compliance

Completed

Infermedica has registered its medical device, Triage and Intake, in Brazil and ensures compliance with ANVISA regulation via a local authorized representative. This partnership guarantees our AI healthcare solutions meet Brazilian regulations to be legally available in the market.

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Data Protection

Completed

Brazil’s General Data Protection Law (LGPD), modeled on the EU’s GDPR, regulates personal data collection, processing, storage and use. Infermedica complies fully with GDPR, applying strong data protection measures to safeguard privacy and ensure top standards of security and transparency.

Medical Device Compliance

Completed

Infermedica’s products comply with UK medical device software regulations and are registered with the MHRA. Our Medical Guidance Platform (MGP), including its modules—Triage, Intake, and Follow-up—is certified as a Class IIb medical device under the EU MDR, which is currently recognised in Great Britain for market access.

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GDPR

Completed

The UK upholds GDPR principles with changes via the Data Protection Act 2018. Infermedica fully complies with GDPR, using strong data protection measures to protect user privacy and uphold top standards of security and transparency.

Medical Device Compliance

Completed

Infermedica’s products meet Swiss medical software regulations. As Switzerland recognizes EU MDR compliance, our solutions can be marketed there. We’ve registered our modules, monitor local regulations, and work with local Authorized Representatives to ensure ongoing compliance.

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Data protection

Completed

The revised Swiss data protection law aligns with GDPR, ensuring the free flow of data between the EU and Switzerland. Infermedica is fully compliant with GDPR, adhering to the highest standards of data protection and privacy.

Devices under Medical Certification

MDR class IIb compliance

At present, our Triage, Intake, and Follow-up modules are integrated into a single medical device product—the Medical Guidance Platform (MGP). This cutting-edge ecosystem is available via iFrame or Platform API and is certified as a Class IIb medical device under the EU MDR.

[Learn more about MGP](/content/platform "Learn more about MGP"/index.html)

Legacy certification status

Legacy modules under the names Infermedica Triage, Infermedica Intake, and Infermedica Call Center Triage are legacy Class I medical devices, registered and fully compliant with the European Medical Device Directive (MDD). They will remain available under this classification until the end of 2028.

[Learn more](/content/solutions/triage "Learn more"/index.html)

Looking for a more flexible solution? Discover Engine API

Engine API is a vital component of medical devices, designed without a front-end or fixed structure, allowing seamless and rapid integration into any system. We provide comprehensive documentation to streamline your process and significantly accelerate your own certification journey.

[Ask about Engine API](/content/get-in-touch "Ask about Engine API"/index.html)

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Integrated Quality Management Systems built to meet the highest and most rigorous standards

All Infermedica software medical devices are crafted under a stringent, integrated Quality Management System, adhering to the rigorous standards of ISO 13485 and ISO 27001. Our dedicated managers ensure that every line of code is carefully planned, developed with precision, verified through robust QA processes, and validated to meet the highest quality benchmarks.

Quality Management System certified with PN-EN ISO 13485:2016

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Processes and Development Procedures certified with ISO 27001:2017

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