Guardian Medical USA is an Ohio-based contract manufacturer of sterile barrier packaging for medical devices, built around its CapSure™ system for protecting orthopedic implants. Founded by entrepreneurs with backgrounds in plastics, injection molding, orthopedic surgery and sterile packaging, the company designs, manufactures and services custom packaging in clean-room facilities. CapSure is pre-validated with a 10-year shelf life and uses a minimal-footprint design intended to simplify packaging while reducing sterilization, shipping and storage demands.
ISO 13485
FDA Registered
Registration
Class 7 Clean Rooms
Compliance program
Class 8 Clean Rooms
Compliance program
Sterile Barrier Validated with 10-Year Shelf Life
Compliance program
FDA
Quality certification
ISO7CLEANROOM
Quality certification
STERILEBARRIERVALIDATION
Quality certification
Oliver Healthcare PackagingFounded as a machinery company in 1890, Oliver Healthcare Packaging became focused on medical packaging in 1968 and now builds its identity around protecting patients. The company designs and manufactures flexible sterile barrier packaging for healthcare customers, with engineering support available through its international network of technical centers.HAMILTON, OH
Infinite Medical SolutionsBuilt on more than 40 years of experience, Infinite Medical Solutions manufactures precision orthopedic and trauma implants and manages their engineering, processing, and assembly in Eastlake, Ohio. Its 200,000-square-foot facility on 14 acres is set up to scale complex medical-device projects, from spinal implant assemblies to micro-machined suture buttons. The company’s quality systems comply with ISO 9001, ISO 13485, and AS9100, reflecting its roots in aerospace as well as medical manufacturing.EASTLAKE, OH
Polymer MedicalOrchard Park’s Polymer Medical makes contract injection-molded plastic components and finished devices for healthcare and bioscience companies. Led by plastics-industry veterans Ben Harp and Tom Rybicki, the company carries projects from tooling and prototyping through cleanroom assembly, with particular experience in complex, critical-to-life applications. Polymer Medical is ISO 13485:2016 certified for contract plastic injection molding and manufacturing of medical devices and components.ORCHARD PARK, NY
SencorpWhiteSencorpWhite is an Ohio-based industrial equipment company known for supporting a group of specialized manufacturing brands. Through CeraTek, it serves medical-device manufacturers with heat-sealing equipment for sterile packaging, while its broader service operation provides field support and equipment upgrades for customers’ production needs.HAMILTON, OH