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
ISO 14001 – Environmental
ISO 45001 – Health and Safety
ISO 13485 – Medical Device
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
ATP
Quality certification
CEMARKING
Quality certification
MDR
Quality certification