Quality Commitment | CarTika Medical
Quality Commitment

Your Assurance of Outstanding Performance

CarTika Medical Devices
CarTika Medical, a part of Teleflex Medical OEM, ensures all design requirements are met with manufacturing processes that are reliable and result in outstanding products. We achieve this by continually improving our processes and performance, and by maintaining the effectiveness of the quality management system.

Our commitment to quality includes:

  • ISO 13485:2003 and ISO 9001:2008 certification
  • FDA registered
  • ISO 7 (Class 10,000) certified clean room
  • Validations: Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)
  • GMP compliant
  • Risk assessment compliant to ISO 14971
  • Product design verification
CarTika Medical Devices FDA