Overview

Building on more than two decades of medical device quality and compliance experience, RdQCC provides QMS and Design & Development File remediation services to align with FDA requirements. We work with medical device companies to assess gaps, remediate quality management systems, strengthen design and development documentation, and improve FDA readiness for regulatory submissions and inspections.

RdQCC also develops AI-powered solutions that extend quality and risk management into daily operations. Its DefectAI platform leverages multimodal AI models trained on proprietary datasets to detect and annotate manufacturing nonconformities using image and video data. Powered by DefectAI, the QRobot inspection system autonomously identifies, picks, and removes defective products in real time, improving inspection consistency and manufacturing efficiency. Driven by an AI-powered risk reasoning engine, Risk-Chat proactively identifies, analyzes, and mitigates potential risks throughout the new product development lifecycle.

 

Mission and Value

Secure innovation and protect users(patients).

 

Goals and Objectives

Strengthen FDA compliance, mitigate Quality Management System (QMS) and product design & development file risks, and enhance product quality and reliability through quality expertise.

 

Logo

Building Product Together

 

Philosophy

You change the world, we make it affordable and secure.