Quality Commitment | CarTika Medical
Quality Commitment

Dedication to Quality

CarTika Medical Devices

Quality is part of our culture at CarTika Medical, a part of Teleflex Medical OEM, and all of our team is proud of our quality standards. We continually improve our processes and performance, and maintain 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
ISO9001ISO13485