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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.
Navigating the diverse regulatory landscapes of global markets is crucial. Our AI platform provides comprehensive regulatory strategy development and submission support for:
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:
We possess specialized expertise in the regulatory requirements for IVDs and medical devices used in nucleic acid-based diagnostics. Our services include:
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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