We help teams evaluate how software functions, intended use, claims, architecture, and planned changes affect their regulatory strategy and quality practices. Our focus includes SaMD, AI-enabled devices, imaging systems, and software-heavy laboratory technologies.

Our experts have spent years working with SaMD products, and have been at the forefront of both implementing, and evaluating Machine Leaning (ML) and other AI solutions.

In March 2023, the FDA declared its intention to no longer accept submissions for “Cyber Devices” without a plan to “monitor, identify, and address cybersecurity issues.

Our teams leverage IMDRF, NIST, and other cybersecurity guidance and standards to help craft practical solutions for SBOMs, Cybersecurity Risk Management, Modifications and Communications topics for devices from Development to End-of-Support phases. .

Transitioning from the EU’s MDD/IVD to the MDR/IVDR can be difficult for any organization. Our teams have first hand experience transitioning Quality Systems under some of the most unique circumstances, and have even secured some of the first Class III product certifications.

Is it a product defect or use error? How likely is it to occur? Is the frequency of occurrence documented in the Risk Management File supported by objective evidence? Are risk assessments consistent across your Quality Management System?

Effective risk management is a foundational element of a robust QMS. With the FDA’s Quality Management System Regulation (QMSR) aligning more closely with ISO 13485, integrating risk-based thinking throughout quality processes is more important than ever. At TRCG, we translate the principles of ISO 14971, ISO 13485, and QMSR into practical, consistent risk management strategies that strengthen compliance, support informed decision-making, and improve medical device safety and performance.

Post Market activities are some of the most high volume, and difficult parts of the Quality System to get right. Roughly 17% of all FDA 483s written in 2022 (the largest category) were cited in Post Market activities including Complaint records, Risk evaluation, and Reporting.

Our team of experts understands the red flags that tip off regulators, and can guide you through repeatable risk evaluation and reporting decisions that will stand up to your next inspection’s scrutiny

The second largest 2022 FDA 483 source, and probably the greatest influence on the performance of your product in the field, and ultimately your bottom line.

From pre-launch readiness evaluations, to field performance informed deep dives; our team specializes in identifying opportunities for improvement during the design lifecycle — helping you improve your product, and reduce field complaints over time.

Findings happen. And while they aren’t the end of the world, your response to them can have significant impact on your business going forward.

Our expert have decades of experience not only responding to regulator findings, but issuing findings of their own. This gives our team unique insight on the expectations for your finding responses. Let us help make sure your first response inspires the confidence to make it your only response.

Not sure how to close that old recall? Having trouble with your Root Cause Analysis and Effectiveness Check? Our team has handled these topics for some of the largest manufacturers in the world, and understand the nuances to effectively guide your organization.