Keystone America, 49 S Main St, Pittston, PA 18640, US

IRC is a leading provider of regulatory consulting expertise in the medical device industry, specializing in assisting with quality management testing and FDA submissions for devices to be sold in the US market. With a team of expert engineers and partner testing labs, IRC guides clients through the rigorous process of international development and marketing, ensuring compliance and minimizing risks. Offering services in both the United States and Shanghai, China, IRC also provides regulatory consulting for medical device registration and license holder services in Korea through IRC Korea. Their comprehensive range of services includes FDA 510(k) document creation, testing and validation assistance, quality systems audits, and post-market issue support, making them a trusted partner in achieving FDA compliance. Generated from the website

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