SpecialTeam

SpecialTeam is an FDA registered and ISO 13485:2016 certified contract manufacturer of medical devices. We provide complete turnkey services, including Cleaning, Assembly, Packaging, and contract Sterilization1, Validation, and Testing of medical devices and components.

We occupy a 10,000 square foot facility in Yorba Linda, California. This location contains approximately 2000 square feet of with ISO 14644-2: 2000 and ISO 14644-3 certified cleanroom manufacturing. Other capabilities include UV Curing, Ultrasonic Cleaning, Sealing to ASTM Standards, and UDI compliant labeling.

SpecialTeam provides services to start-up medical device companies, mid-size companies, as well as high-volume clients. Our team represents over 60 years of experience in assembly and packaging of sterile disposable devices. We can perform all activities required to package medical devices to required specs, including procuring qualified materials/goods/services from our established supplier networks.

1. We have formed alliances with several certified facilities that provide the sterilization services. Please contact us for more information.

Company’s Keywords:

medical device manufacturing, cleanroom assembly, packaging, specialty packaging, medical package testing, contract manufacturing, iso 13485, turnkey manufacturing, complete assembly, fullfilment, medical device validation, decontamination, disinfection, device testing, regulatory consulting, fda class 1, class ii device testing, iso class 5, iso class 6, iso class 7, iso class 8, process development, iso 9001, fda registration, sterilization, validation services, testing services, cleanroom injection molding