Medical Devices - Carlsbad, California, United States
Integra Biotechnical is a vertically integrated, turnkey manufacturing company with a full range of services from material procurement to injection molding, assembly, packaging and sterilization management. Strategic location is one of Integra's greatest attributes. Our Tijuana, Mexico facility provides a near-shore option for off-shore manufacturing needs. From new product launches to existing product transfers, Integra has the processes in place to help customers realize cost savings and quality improvements. We strive to maintain quality systems that meet or exceed requirements for leading medical device OEMs. Our customers have experienced a reduction in costs, managed unexpected capacity restraints, and accelerated product launch timelines. Integra is FDA registered and ISO 13485:2003 certified. Our manufacturing facilities feature ISO Class 8 clean rooms. Our Carlsbad location features over 50,000 sq. ft. and is dedicated to injection molding with presses ranging from 18 to 550 ton. Assembly and manufacturing of Class II and Class III medical devices is done at our Tijuana, Mexico facility; 60,000 sq. ft. with 25,000 sq. ft. of clean room space.
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