Certificates: 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
