Compliance

CRI is a leading medical device manufacturer specializing in interventional delivery devices, custom complex balloon development and high volume assembly. CRI manufactures a branded line of women’s health products and distributes through Thomas Medical.

International Regulatory Compliance Information

CRI is 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  
CRI Indianapolis Registration Number: 1833117

International Certifications

EUROPE

EC Certificate CE 66745.pdf

EC Certificate CE 597141.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

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