Founded in Ohio in 1979, CSafe makes temperature-controlled shipping systems that protect life-science products from the manufacturer to the patient. Its active and passive cold-chain packaging is paired with qualification services and CSafe Connect real-time shipment visibility, supporting deliveries across more than 185 countries. The company says its products have safely carried more than 10 billion doses.
ISO 9001 – Quality System
certification
ISO 14001 – Environmental
certification
ISO 45001 – Health and Safety
certification
ISO 13485 – Medical Device
certification
United States Food and Drug Administration (FDA) 21 CFR Part 820
compliance_program
Accord Transport Perishables (ATP)
compliance_program
MDR – CE Medical Device Requirement
compliance_program
Federal Aviation Administration (FAA) Part 145
registration
European Union Aviation Safety Agency (EASA) Part 145
registration
Federal Aviation Administration (FAA) Part 21
registration