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

EC Certificate (PDF)

Establishment License (PDF)


Global Regulatory Representatives 

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



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