Integra Biotechnical, LLC Email Format

Medical DevicesCalifornia, United States501-1000 Employees

Integra Biotechnical, LLC is a medical equipment manufacturer that provides turnkey, vertically integrated services spanning material procurement, injection molding, assembly, packaging, and sterilization management. Its operations include a Carlsbad, California facility dedicated to injection molding and a Tijuana, Mexico site focused on assembly and manufacturing of Class II and Class III medical devices, supported by ISO-certified quality systems and ISO Class 8 clean rooms. The company positions itself to support near-shore and off-shore manufacturing needs, offering processes for product launches and transfers with aims of cost savings and quality improvements for medical device OEMs. Based in California and operating across North America, Integra Biotechnical emphasizes compliance with regulatory standards, including FDA registration and ISO 13485:2003 certification, to serve customers seeking reliable, end-to-end manufacturing solutions for medical devices.

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