Thomas Regulatory Consulting Group
Quality and regulatory leadership for digital health
TRCG helps medical imaging, AI, and software-heavy device companies make product decisions, build practical quality systems, and manage risk throughout the product lifecycle.
What We Do
TRCG is a boutique quality and regulatory consulting firm focused on digital health. We bring experience in medical software, imaging, AI, and laboratory technologies, together with corporate audit and governance experience. We help teams clarify decisions, establish usable processes, and address problems across organizational boundaries. We are also developing tools to support regulatory strategy and complaint operations.
Experienced leadership for early-stage companies and organizations managing a vacancy or transition. We support product and quality governance, regulatory strategy, FDA interactions, and practical supplier oversight, with responsibilities tailored to your team.
Fractional Quality and Regulatory Leadership
Connect risk assessment, clinical evidence support, and complaint handling. We are seeking 2–3 PACS manufacturers for a paid pilot combining scoped risk-framework improvements with evaluation of our complaint-handling technology, which is still in development.
Risk Management and Complaint Operations
Support for quality systems, design quality, audits, remediation, and regulatory strategy. Training can combine live instruction with discussion-based audio, video, scenarios, and knowledge checks, according to the engagement.
Focused Consulting and Training
AI-Assisted Complaint Handling
Manage complaints by exception.
Your team shouldn’t have to build every complaint assessment from scratch.
ComplAInts uses your approved procedures, product information, risk framework, and supporting clinical evidence to prepare draft assessments, justifications, and evidence links—then brings exceptions and required decisions to the people responsible.
Designed to reduce repetitive assessment work, make better use of your team’s time, and support consistent, defensible complaint records.
We’re recruiting PACS manufacturers for pilot participation.
Upcoming Events
Let’s discuss what your team needs
Tell us about your product, leadership needs, or risk and complaint challenges. We’ll use an initial conversation to understand the situation and whether TRCG is a fit.
Five common myths around cybersecurity, and ways to implement basic protections within your business