Medical Device Innovation for Small Populations. Expert navigation of HDE, PMA, and 510(k) pathways for orphan devices.

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

Navigating the diverse regulatory landscapes of global markets is crucial for companies like Regal Intel. Our AI platform, developed by Regal Intel, 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, ensuring that our Regal Technology Partners stay ahead in the compliance landscape.

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, through its Regal Technology Partners division, offers: 

SaMD Validation: We support software validation, verification, and cybersecurity for AI/ML-based SaMD. Our Regal Technology Partners 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.

At Regal Intel, 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: Regal Intel assists with the development and regulatory strategies for AI-powered diagnostic tools that analyze medical images or genetic data to detect patterns that are difficult for humans to identify. 

Quality Management Systems (QMS): Regal Technology Partners help with QMS implementation and auditing, including certifications like ISO 13485 and MDSAP, to ensure robust quality standards for all device types.