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
US FDA Quality Systems Regulations (QSR)
U.S. Food and Drug Administration
CRI Indianapolis Registration Number: 1833117
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