TRCG Success

Our Experience

At TRCG, we specialize in elevating MedTech companies to meet and exceed global regulatory standards. Our experienced team excels in three core areas:

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.

Our Past Work

Take a look at our recent work.

  • A large medical device business was experiencing a high volume of software based product quality issues with a newly launched product, but their internal assessments concluded their quality system was performing adequately.

  • OUR ASSOCIATES PERFORMED AN ASSESSMENT TO ASSESS THE FOLLOWING:

    Risk of reactive inspection from externally visible signals

    Audit risk of product quality situation

    The Quality System’s ability to manage product quality issues

  • We were able to determine that externally visible signals could lead to a reactive inspection based on likely analysis methodologies.

    Our teams determined that if a reactive inspection was initiated, the risk to the business was very high and could lead an inspector to believe the organization could not effectively correct or prevent issues, presenting a continued unacceptable safety risk to patients and users and the perception of repeat recalls for a single software defect.

    We determined that while the organizations QMS was driving the generation of necessary objective evidence to support the resolution of issues; key personnel and processes were ineffectively performing corrective and prevention steps, resulting in multiple design changes to resolve a single software defect.

High Recall Volume

  • A large global medical device conglomerate implemented a Machine Learning based Post Market Surveillance (complaint handling and reporting) solution.

  • OUR ASSOCIATES PERFORMED AN ASSESSMENT TO ASSESS THE FOLLOWING:

    Audit risk of algorithm development process

    Effectivity of solution for performing QMS relevant tasks

    Sustainability of the solution

  • We were able to determine that while audit risk was moderate, small changes to the use case definition and parameters would dramatically lower residual contextual audit risk.

    While very effective for several modalities; some major modalities suffered from invisible defects and would remain ineffective for the foreseeable future due to a misalignment of the algorithm model and the clinically relevant risk factor.

    The algorithm sustainability plan was ineffective, and a retraining plan would be necessary to mitigate the limitations of the algorithm training set and avoid data bias driven systemic defects with high regulatory risk beginning in as little as 6 months.

AI Complaint Handling

Testimonial

Want to be assured we're the right team for you? Read what clients are saying.

“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.”
— H. Baez, VP Manufacturing Quality

Let’s Work Together

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