Our Publications

White Papers

Learn about the latest regularly developments.

Blog Posts

Our collection of AI/ML, Digital Health, Regulatory Compliance, and Health Equity topics.

Blog
"I Learned It By Watching You, Dad!": What Your AI Solution May Be Learning, And What YOU Should Learn From the "AI Winter Break Hypothesis"
"I Learned It By Watching You, Dad!": What Your AI Solution May Be Learning, And What YOU Should Learn From the "AI Winter Break Hypothesis"
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A New AI Rule: How to keep from violating the HHS antidiscrimination regulation.
A New AI Rule: How to keep from violating the HHS antidiscrimination regulation.
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Things got a lot more interesting for AI in the US.
Things got a lot more interesting for AI in the US.

Yesterday, President Biden signed an #AI #ExecutiveOrder (EO) to promote responsible and equitable development and use of AI across the U.S. Govt.

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3 Tips to a Successful Audit
3 Tips to a Successful Audit
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5 Tips For Better CAPAs
5 Tips For Better CAPAs

Looking for ways to strengthen your CAPA program? Check out our 5 tips to keep your CAPAs effective, and out of 483s.

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The FDA’s Cybersecurity Guidance for Medical Devices
The FDA’s Cybersecurity Guidance for Medical Devices

Back in March, the FDA released a guidance on cybersecurity. Since then questions have risen as to how to how to incorporate the expectations into quality systems.

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AI & Quality
AI & Quality

Reflections on a conference talk about AI solutions in Medical Device Quality Systems

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Health Equity, the Quality Professional’s Dilemma
Health Equity, the Quality Professional’s Dilemma

In the midst of #HTLH2022 I've read some great posts about what #healthEquity means to different healthcare providers. Here’s my take for the Quality professional.

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Featured Case Studies

Take a look at case studies of our recent work.

  • 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.

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Webinars & Videos

Educational video content from TRCG and beyond.

TUV's Dr. Fuh gives his advice for Digital Health Manufacturers following the EU AI Act

PBS News discusses the prevalence and impact of embedded bias in our Healthcare System

TUV's Dr. Fuh and TRCG's Khalil Thomas talk algorithm bias and the EU AI Act

TRCG's Khalil Thomas shares his thoughts on effective AI governance strategies.

In The News

Staff and company highlights in the media

How a colorblind health care system results in Black death

OPINION IN THEGRIO: Inequities in health care — from devices that don't consider darker skin tones to our exclusions from trials and studies — require that we ask questions at every level of our health care system to avoid unnecessary deaths.

Let’s Work Together

Get in touch and one of our project managers will contact you about beginning the proposal process.