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POLISHArtificial Intelligence
AI Medical Device Regulatory Consulting
AI has moved beyond being merely a technological innovation and has entered an era in which it must be governed by regulatory frameworks.
We provide integrated regulatory consulting services for AI-based medical devices by comprehensively analyzing the regulatory requirements of the worldโs major jurisdictions, including the European Union (EU) and the United States (FDA). Our mission is to support manufacturers in developing AI medical devices that are safe, compliant, and trusted in the global market.
European Union (EU): AI Act and CE MDR
In the European Union, AI medical devices are regulated as high-risk AI systems under the AI Act in conjunction with the Medical Device Regulation (MDR, Regulation (EU) 2017/745).
We provide end-to-end regulatory support in accordance with EU requirements, covering the entire lifecycle from CE certification to technical documentation, and from QMS to data governance and human oversight documentation.
Our Services
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CE MDR conformity assessment support for AI medical devices
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Preparation and consulting for technical documentation for high-risk AI systems (including risk management, usability engineering, and software validation)
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GMP / QMS implementation and certification support for AI medical devices (including human oversight requirements)
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Review and documentation support for data governance requirements
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Cybersecurity testing strategy and technical documentation support
United States (FDA): PCCP for AI/ML-Based Medical Devices
In the United States, AI/ML-based medical devices are regulated through the Predetermined Change Control Plan (PCCP) framework, rather than through a separate new regulation. The FDA uses PCCP to control and manage post-market changes to AI/ML medical devices.
In accordance with FDA PCCP guidance, we provide an integrated PCCP documentation and regulatory strategy solution.
Our Services
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Consulting and documentation support for implementation of PCCP requirements
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Cybersecurity testing strategy and technical documentation support
We provide technical support to assist AI medical device technical documentation.
Contact us today, and let's embark on this journey together.
Experience the confidence that comes with working with a proven leader in medical device registration.