The GTA team understands the need of device manufacturers to work with FDA certified factories that meet strict ISO 13485 requirements.  We also understand the strict quality, packaging and labeling requirements applicable to medical products.  In addition, we understand your need to be able to track manufacturing lot numbers to maximize compliance while reducing risk.

 

GTA has assisted a leading medical device manufacturer offshore the production of leg pressure devices designed to prevent venal thrombosis.  GTA’s ability to identify quality factory sources, train them to make the product, negotiate pricing, assure quality and on-time delivery of the products resulted in major cost savings for its customer. (Read the case study HERE.) 

Please contact us if you would like to discuss options or receive a free sourcing assessment.