Medical Technology
FY22 FDA Device 483's
At TRCG, we believe that our work has a direct impact on the health and well-being of patients and users around the world. Our philosophy is centered on this core principle, and we are committed to providing our clients with the guidance and support they need to produce better products that are safe, effective, and meet the needs of those who use them.
Our approach is rooted in collaboration, transparency, and a deep understanding of the regulatory landscape. We work closely with our clients to understand their unique needs and challenges, and we leverage our expertise and industry knowledge to provide tailored solutions that drive impact.
We believe that compliance is not just a regulatory requirement, but a critical component of ensuring that medical devices are safe and effective for patients and users. Our team of experts is dedicated to staying up-to-date on the latest regulations and best practices, and we work tirelessly to help our clients navigate the complex landscape of compliance.
We also understand that our work does not end with regulatory compliance. We believe that the best medical devices are those that are designed with the needs of patients and users in mind. That's why we prioritize user-centered design and human factors engineering in our consulting work, helping our clients to create products that are intuitive, easy to use, and meet the needs of those who rely on them.
Above all, our philosophy is rooted in a deep commitment to making a positive impact on the world. We believe that by helping our clients produce better products that are safe, effective, and meet the needs of patients and users, we can contribute to a world where everyone has access to high-quality medical devices that improve their health and well-being.
Specialties
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With the relatively recent Software as a Medical Device (SaMD) regulation, FDAs multiple Artificial Intelligence guidance, and the pending EU AI Act; many organizations still struggle with how to adapt their Quality Systems to these new technologies regulatory frameworks.
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.
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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. .
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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.
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Is it a product defect, or user error? Likely or unlikely? Is the frequency of occurrence in the Risk File substanstantiated? Are my risk assessments throughout my Quality System consistent?
As a foundational element of any Quality System, it’s important to get Risk right. Translating ISO 14971 to real world applications of risk is a bedrock capability of our practice.
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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
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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.
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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.
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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.
Our Services
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Audit
Whether you need a full system, single element, mock inspection, or issue focused audit; TRCG has the experience to highlight your risks before an external agency does.
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Fractional Support
In this dynamic world, your workload changes before your staffing budget. TRCG can provide support at a fraction of the cost of a full time employee faster than hiring and onboarding a new employee.
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Consulting
Drafting a new process? Optimizing a procedure? Training to a new standard? Remediating a nonconformance? TRCG can guide you to an effective and sustainable solution.