Certified Compliance Solutions
Medical Equipment ManufacturingCalifornia, United States2-10 Employees
Certified Compliance Solutions is a small San Diego, California-based firm specializing in regulatory and quality compliance for medical devices, pharmaceuticals, and biotech. With more than 20 years of industry experience, the company has assisted over 200 clients in meeting QSR and FDA requirements. It offers a full spectrum of services, including quality management, design control, software validation, and software development, spanning custom medical device development, independent testing, and 510(k) submissions. It emphasizes alignment with FDA regulations and ISO standards and backs its work with guarantees tied to those standards. It has been engaged by the FDA Headquarters to provide software training for FDA investigators, reflecting its role as a regulatory resource. Based in the San Diego region, the company notes its aim of clarifying regulatory requirements for medical devices and ensuring compliance with both U.S. and European Community regulations.