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, Call Center Triage, and Follow-up—is certified as a Class IIb medical device under the EU MDR.
Security ISO 27001
Completed
We offer proven systems compliant with industry standards, featuring robust security measures and ongoing oversight through regular penetration testing.
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.
Devices under Medical Certification
Certification status
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.
MDR compliance
Today, Triage, Intake, Call Center Triage and Follow-up modules have been 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.
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.
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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.
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Quality Management System certified with PN-EN ISO 13485:2016
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Processes and Development Procedures certified with ISO 27001:2017