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Medical Devices & IVDs: AI-Powered Regulatory Intelligence

Executive Summary

Regal Intel offers a full spectrum of regulatory consulting services for medical device and in vitro diagnostic (IVD) manufacturers, with a specialized focus on Software as a Medical Device (SaMD) and AI-powered technologies. Our expertise ensures seamless market access and sustained compliance across global markets, leveraging AI to address unique challenges in development, validation, and post-market surveillance.

Global Regulatory Strategy and Submissions

Navigating the diverse regulatory landscapes of global markets is crucial. Our AI platform provides comprehensive regulatory strategy development and submission support for:


  • FDA Submissions: Expert guidance for FDA 510(k), PMA, IDE, and Q-Submissions.
  • EU MDR & IVDR: Specialized consulting for compliance with the complexities of European regulations, including the development of Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs).
  • AI-Specific Regulatory Pathways: We guide you through the new, evolving regulatory frameworks for AI/ML-based devices, including the Predetermined Change Control Plan (PCCP) and other lifecycle management frameworks from the FDA.

AI-Powered Validation and Lifecycle Management

The regulation of AI/ML-based medical devices requires a new, total product lifecycle (TPLC) approach that facilitates a rapid cycle of improvement while ensuring safety and effectiveness. Regal Intel offers:


  • SaMD Validation: We support software validation, verification, and cybersecurity for AI/ML-based SaMD. We help ensure models are validated on diverse and representative datasets to mitigate bias.
  • Post-Market Surveillance (PMS): Our AI-powered PMS systems can automate complaint handling, conduct trend analysis, and actively monitor for potentially reportable events from large datasets, ensuring ongoing safety and compliance.
  • Risk Management: We implement robust risk management strategies and help you create comprehensive AI policies that address data management, transparency, and validation throughout the TPLC.

Specialized Support for IVDs & Diagnostics

We possess specialized expertise in the regulatory requirements for IVDs and medical devices used in nucleic acid-based diagnostics. Our services include:


  • IVD Regulatory Strategy: Guiding manufacturers through the complexities of IVD regulations and ensuring accurate clinical performance evaluation and validation.
  • AI in Diagnostics: We assist with the development and regulatory strategies for AI-powered diagnostic tools that analyze medical images or genetic data to detect patterns that are difficult to detect by humans.
  • Quality Management Systems (QMS): We assist with QMS implementation and auditing, including certifications like ISO 13485 and MDSAP, to ensure robust quality standards for all device types.

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Regal Intel, Inc. is a 501(c)(3) public charity. All contributions are tax-deductible to the extent allowed by law. Copyright © 2025 Regal Intel - All Rights Reserved.

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