Nearshore Outsourcing Solutions for Medical Devices
IIMAK Medical Device Assembly is your North American Outsourcing Solution for low-cost assembly and packaging of Class I and II Medical Devices. Headquartered in Buffalo, New York, our state-of-the-art nearshore manufacturing operation in Reynosa, Mexico, is ISO 13485 certified and FDA registered.
Outsourcing with IIMAK is hassle-free, with a flexible, customized program to fit your specific contract manufacturing requirements. Small and medium-sized companies can select just labor assembly or an end-to-end turnkey program, including assistance on clearing regulatory hurdles and process development.
IIMAK's fully credentialed nearshore location offers low cost labor, easy accessibility, convenient communications and fast shipments to the US. Partner with IIMAK for cost effective assembly, rapid startup, and smooth, high quality production operations and distribution.
Learn more about our medical device capabilities.
Check out the video of our state-of-the-art near-shore manufacturing operation in Reynosa, Mexico.
Capabilities
Specialized equipment and processes suited to medical device assembly featuring an ISO-08 Clean Room, Class 1000 laminar flow stations and general clean assembly areas.
Quality
As an ISO 13485 facility, formal quality procedures are integral to all manufacturing processes to assure your products are produced to your exact specifications.
About Us
Located in an industrial park with many other global companies, the secure and fully licensed maquiladora is just 3.2 miles from the Texas border.