IPAX, INC.

IPAX, Inc. is an FDA-registered and ISO 13485-2016 certified contract manufacturer specializing in high-mix, complex disposable medical devices. The company provides finished medical device manufacturing, assembly, and packaging services to entrepreneurial medical device companies seeking to accelerate time-to-market with minimal capital investment. IPAX offers cleanroom manufacturing capabilities with expertise in EO and E-beam sterilization, sterilization validation, and sterile barrier validation. The facility accommodates both low-volume, quick-turnaround production and high-volume, large-scale manufacturing. Services include vendor sourcing, supply chain management, root-cause non-conformance elimination, and regulatory filing support. IPAX maintains cGMP compliance and focuses on continuous process improvement to achieve zero-defect manufacturing standards.