Thomas Regulatory Consulting Group
Quality & Regulatory Compliance expertise for the Digital Health space
What We Do
Leveraging deep Quality & Regulatory Compliance expertise to bring Digital Health solutions to market faster, and help them perform better across a broader demographic.
Fractional Quality Support
Tailored, flexible quality support to meet your specific project needs.
Quality System Development
Specializing in SaMD and AI/ML, we build robust systems that stand the test of market and regulatory scrutiny.
Corrective & Preventive Action (CAPA) & Recall Support
Proactive and reactive strategies for product and process.
Quality System Consulting
Internal & External Audit Support
Comprehensive auditing serves to support compliance and excellence (including FDA, ISO, & MDSAP style audits).
Supplier Audit Management
Ensuring supplier compliance and product quality through meticulous evaluation and oversight
Mock Inspections & Training
Ensuring your organization remains audit ready because practice makes perfect.
Quality System Auditing
Algorithm Bias Mitigation
Dedicated to ensuring fairness and equity in AI/ML applications. Quality System Development & Optimization
Quality System Optimization
Specializing in SaMD and AI/ML, we build robust systems that stand the test of market and regulatory scrutiny.
AI/ML Market Authorization Support
Expert navigation through the complex pathways of market authorization, including Predetermined Change Control Plans (PCCPs).
Digital Health Solutions
Who is TRCG
“We’ve worked hard to make compliance a means of making business stronger. If it’s just another box to check, we’re doing it wrong.”
Welcome to Thomas Regulatory Consulting Group (TRCG), a boutique Digital Health Consulting firm that leverages deep Quality & Regulatory Compliance expertise to bring Digital Health solutions to market faster, and help them perform better across a broader demographic.
With an extensive background in Software as a Medical Device (SaMD), Clinical Decision Support (CDS), Artificial Intelligence and Machine Learning (AI/ML), as well as Cybersecurity and Data Privacy; TRCG associates are here to deliver comprehensive regulatory compliance solutions tailored to your Software and AI/ML technologies.
Our comprehensive services guide clients through the intricate and evolving Digital MedTech regulatory landscape with confidence. From fractional support to Quality System design and support, Audit and Assessment services, and Education & Training for Software, AI/ML, Cybersecurity, and Privacy topics, we offer a holistic approach to regulatory compliance.
At TRCG, our mission is clear: empower our clients to achieve regulatory compliance, mitigate risk, and optimize success in their business endeavors.
Let’s Work Together
We’re always looking for new opportunities and are comfortable working internationally. Please get in touch and one of our project managers will contact you about beginning the proposal process.
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