International Regulatory Compliance Information

 

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)

 


 

International Certifications

EUROPE
EC Certificate (PDF)


HEALTH CANADA
Establishment License (PDF)
 


 

Global Regulatory Representatives 

EC REPRESENTATIVE EUROPE
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
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
 


 

 Self-Survey

 For your convenience, we have prepared a Vendor Self-Survey Package containing all information you will need to qualify CRI as a vendor.

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