The plant is the first Class III active-implantable medtech manufacturing site in Mexico to receive FDA approval, according to the Plano, Texas-based company. Integer has added Class 7 and 8 cleanrooms, and manufacturing and capital equipment to the Tijuana-North plant, which may be expanded further. Integer was already doing IPG manufacturing at Tijuana-North as well as at its Montevideo, Uruguay, and Plymouth, Minn., facilities.
“Integer’s key objective is to assist OEMs in bringing their innovative therapies to market efficiently, reliably and cost effectively.” said Joel Becker, president of Integer’s cardiac rhythm management and neuromodulation business, in a news release. “This regulatory approval and facility expansion help us offer our customers expanded capacity and flexibility.”
The site is supported by onsite engineering and technical as well as operational staff members trained at Integer’s Research and Development Center of Excellence for IPG.
“We continue to make strategic investments to support our customers’ growth and advance us toward our vision of being our customers’ partner of choice for innovative medical technologies,” Becker added. “Integer’s goal is to offer best-in-class quality, service and value, and support our customers with the most comprehensive design, development and manufacturing services available for Class III medical device systems.”