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A global medical device company was facing substantial operational and skill gap challenges as a result of high-volume data. The organization had to immediately assess the Design History File (DHF) and fix flaws in the product development process. This is known as DHF remediation. The remediation of a quality system is an extensive, time-consuming task that requires expertise and a solid understanding of risk management.

LTTS provided consulting and execution support for DHF and product recalls. The customer was able to close DHF remediation within FDA's 3-month deadline with LTTS' extensive team support. This process was cost-effective and did not overwhelm customer resources.

LTTS provides a comprehensive array of QARA capabilities to the medical device industry. With a robust infrastructure and an in-depth consulting approach, LTTS can help medical device manufacturers to remediate DHF with precision and perfection.