Caelin Medical’s facilities are ISO 13485:2016 certified, registered with the US Food and Drug Administration and compliant with the regulatory requirements of 21 CFR820. Our regulatory team ensures we remain up to date and state-of-the-art with all applicable standards and regulations. We manufacture and partner with facilities in conformance and compliance with:

• ISO 13485 – Medical Devices _ Quality management system
• ISO 11607 – Packaging for Terminally sterilized Medical Devices
• ISO 11135 – Sterilization of health-care products Ethylene Oxide
• ISO 11137 – Sterilization of health-care products Radiation
• ISO 10993 – Biological evaluation of medical devices
• ISO 14971 – Risk management for medical devices
• 21 CFR 801, 803, 820 – US Federal Regulations
• 2017/745 – European Union Medical Devices Regulations
• MDSAP – Medical Device Single Auditor Program
• HSA regulations
• IEC 62366 – application of usability engineering to medical devices

Caelin encourages you to contact us, discuss your project with our experts and see how we can transfer your off-shore facilities to a near-shore solution, leading to supply chain maximization, geopolitical insulation and cost of goods repatriation.