RCA provides a range of quality, regulatory, and compliance services to assist global companies obtain product clearance and/or approval in the United States: U.S. agent services, compliance with U.S. FDA Quality System Regulations (QSR), ISO 13485, and auditing. It also provides support with RA/QA outsourcing, FDA inspection readiness (including 483/warning letter/consent decree remediation), and global product submissions and registration.
