Our Work
Our Experience, Case Studies, and Testimonials
Our Experience
At TRCG, we specialize in elevating MedTech companies to meet and exceed global regulatory standards. Our team of Quality/Regulatory professionals have owned quality systems for, and support organizations ranging from startups to multi-billion dollar global corporations.
Audit
Our team has performed and managed several dozen Quality System audits. We specialize in QSIT/QSR, MDSAP, ISO 13485 and Reactive style inspections. Our audits are designed to not just produce a list of deficiencies, but help you extract the maximum value from your quality system.
Quality System Design
Our associates have decades of Quality System design, management, and optimization between them. We have conducted MDR/IVDR transitions, managed initial certifications, simplified bloated systems, and managed transitions after M&A activity.
AI Solution Evaluation
With over a decades of experience in digital health and Artificial Intelligence (AI)/Machine Learning (ML) based solutions, our teams leverage their unique insights to evaluate internal AI tools and standalone and embedded product solutions.
Training & Education
Drawing on years of hands-on experience and a proven track record of success. Our training programs empower your team, ensuring they are well-equipped to expertly manage complexities of Audit, Quality Systems, and Digital Health Solutions. By leveraging our deep industry knowledge and expertise, we help you upskill your workforce, fostering a culture of continuous improvement and regulatory excellence.
AI Governance | TRCG Navigating the AI Regulatory Landscape Webinar
Our Past Work
Take a look at case studies of our recent work.
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TRCG Verifies Effectivity of AI Post-Market Surveillance Solution
Learn how TRCG helped a large multinational assess the effectivity of their in-house Machine Learning Post-Market Surveillance solution as well as the governing project and SMEs involved.
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Multinational Uses TRCG to Address a High Volume of Field Product Issues
Uncomfortable with the high volume of field product issues on a new product, a Medical Device manufacturer uses TRCG to identify systemic causes of defects and assess the risk of a reactive inspection.
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TRCG Provides Fractional Quality Support for a Digital Health Startup
Needing to maintain a lean operation, a Digital Health startup partners with TRCG for deep domain expertise and comprehensive support, at a fraction of the cost of a full time employee.
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Large Urban Health System Partners with TRCG to Improve Patient Outcomes
Following updates to Section 1557 requiring Providers to identify and address bias in Clinical/Care Decision Support tools, TRCG helps drive better outcomes and reduce health disparities by addressing embedded bias and patient engagement.
Testimonials
Hear what people have to say about TRCG
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H. Baez, VP Manufacturing Quality, Multinational Medical Device Manufacturer
Big thanks to Thomas Regulatory Consulting Group for their impactful support in a critical moment. Facing a surge in product quality issues, their assessment identified potential triggers for a reactive FDA inspection and highlighted high risks areas where our Quality Management System needed improvement. Post-engagement, we faced an FDA inspection confidently, thanks to their preparation. Khalil and his team's expertise proved crucial in maintaining safety standards for our patients and users, and in protecting our business. Grateful for their invaluable partnership and positive impact on our Quality journey.
Let’s Work Together
Get in touch and one of our project managers will contact you about beginning the proposal process.