International Regulatory Compliance Information
We are US FDA registered, compliant with 21 CFR Part 820, Quality System Regulation, and ISO 13485 certified Manufacturers.
We assist our customers with all of their regulatory requirements.
Quality Management System
ISO 13485 Quality System Certificate (PDF)
US FDA Quality Systems Regulations (QSR)
U.S. Food and Drug Administration
Annual Registration (PDF)
EC Certificate (PDF)
Establishment License (PDF)
Global Regulatory Representatives
EC REPRESENTATIVE EUROPE
2513 BH, The Hague
Tel: (31) (0) 70 345-8570
Fax: (31) (0) 70 346-7299
Notified Body / Registrar / Certification Body
BSI maintains our ISO 13485:2003 and EC Certification
For your convenience, we have prepared a Vendor Self-Survey Package containing all information you will need to qualify CRI as a vendor.