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Your Assurance of Superior Performance
CarTika Medical is dedicated to providing quality medical products to our customers. We partner with our customers, ensuring all design requirements are met or exceeded with manufacturing processes that are reliable and result in high-quality 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
