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.

 DOWNLOAD


 

 

 

Quality Tools and Regulatory Excellence

CRI has developed and implemented a state of the art Quality Management System, combining both simplicity and regulatory compliance. This system includes a Quality Manual consisting of only 3 pages, which is the road map for all of our employees to follow, to stay on track within the system. You will find this roadmap hanging in all areas, as a quick reference to procedural guidance. The document numbering system is designed to allow for quick retrieval and reference to quality procedures, manufacturing and inspection procedures, work instructions and forms. All new hires at all levels receive FDA QSR (GMP) and ISO13485:2003 training within their first week, ensuring critical requirements are understood. This training is repeated quarterly to re-emphasize critical objectives.

  • Fully integrated ERP system
  • Risk management
  • Fully compliant calibration and preventive maintenance system
    • Includes all fixtures and tooling
    • Equipment
    • Gages
    • Scales
    • Dispensing apparatus
  • Six Sigma and lean methodologies
  • Statistical sampling techniques - AQL, C=0, etc.
  • Process capability measurement - Cpk, Ppk, etc.
  • Process validations (IQ/OQ/PQ)
  • Sterilization Validations (ETO / Gamma)
  • Cost containment
  • Design control & documentation
  • Process yield / defect analysis
  • Process control (SPC)
  • Project Management
  • Formal corrective / preventive action
  • Material traceability systems
  • Precision measuring gages
    • Microscopes
    • Micrometers (digital / laser)
    • Pin gages, block gages
    • Calipers
    • Profile projector
    • Instron tensile and compression tester
    • Tubing burst test systems - high pressure
    • Pouch burst testers
    • Leak testing equipment
    • Other various precision gages
Quality Tools and Regulatory Excellence