IRC LLC is a highly specialized regulatory consulting firm that offers expert guidance and support to the medical device industry. With a team of experienced engineers and partner testing labs, they assist in navigating the complex process of quality management, testing, and documentation required for FDA clearance in the US market.
As a trusted partner in FDA compliance, IRC provides a range of professional services, including FDA 510(k) document creation and submissions, testing and validation assistance, quality systems audits, and post-market issue resolution. With their expertise in international development and marketing, IRC also offers regulatory consulting services for medical device registration and licensing in Korea, ensuring smooth market access for their clients.
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