International Organization for Standardization (ISO 13485:2003)
ISO 13485:2003 is an internationally recognized standard that specifies requirements for a quality management system for medical device manufacturers. This certification ensures that the manufacturer can demonstrate its ability to consistently deliver quality medical devices and related services that meet customer requirements and applicable regulatory requirements. It also demonstrates CTK’s proven commitment to quality through an internationally recognized standard.
FDA Current Good Manufacturing Practices (cGMP)
The US FDA issues guidelines for Quality System Regulation to address essential elements such as design, production and distribution of finished products. Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (cGMP’s).
CE Mark for Medical Devices
Most of CTK’s diagnostic test kits are CE marked. In order for products to be placed on the European market, they must meet the requirements of the relevant product directives. With the CE marking, products may be freely distributed and sold throughout the EU.
Device Manufacturing License