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Certificates: ISO 13485

ISO 13485

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

ISO 13485 standards are aimed for companies that design, develop, produce, install or service medical devices, and specify requirements for a quality management system where an organization is able to provide medical devices and related services that consistently meet customers' requirements. This system ensures medical device manufacturers' responsibility and consistent delivery of devices that are safe and effective.

In 2011, Fook Tin was qualified in ISO 13485 CMDCAS. This also recognized Fook Tin as a medical device manufacturer to design and manufacture electronic body fat scales to market to Canada.

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



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