In March 2005, Fook Tin was qualified in ISO 13485. This recognized Fook Tin to be a qualified medical device manufacturer to market its products around the world.

ISO 13485 is applicable to medical device manufacturers. This standard is aimed at companies that design, develop, produce, install or service medical devices and specifies requirements for a quality management system where an organization is able to provide medical devices and related services that consistently meet customers requirements. The quality management system can produce medical device manufacturers having a responsibility to consistently deliver devices that are safe and effective.

ISO 13485 emphasis on meeting customer and regulatory requirements which include:

• Related medical regulation and customer requirements
• Risk management, health, cleanliness, clothing, environmental conditions
• Control of contaminated product
• Design and development
• Labeling and packaging
• Maintenance, Installation and verification
• Preserving product including shelf life
• Compliant and servicing records