The medical device industry is always under pressure to speed up product launches, expand into new markets, and conform to many QARA requirements to remain competitive and prosper. The complexity of the rules and their geographic variance can, however, cause bottlenecks. The client here had limited time to investigate complaints and submit them to the USFDA, with strict deadlines. LTTS assisted this global medical device OEM to streamline its existing failure reporting system. Based on our expertise and impeccable execution, we were able to help the customer meet all milestones for documentation and complaint review. Our Quality Management System, along with our inspection and testing partners, allowed the customer to meet strict product recall deadlines.
With LTTS QARA Capabilities
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