Medical Device

Medical device organization need to demonstrate their ability to provide medical devices that consistently meet customer and regulatory requirements.
Medical devices must be Safe and Effective.

Safe

Means the absence of unreasonable risk of illness or injury associated with the use of the device for its intended uses and conditions of use.

Effective

Means the use of the device for its intended uses and conditions of use, when accompanied by adequate directions for use and warnings against unsafe use, will provide clinically significant results.

Regulatory Compliance

Manufacturers of medical devices must manufacture products according to established quality system requirements.