Safety and Quality

Safety & Quality

A COMMITMENT TO SAFETY, EFFECTIVENESS AND QUALITY

The medical technology industry is committed to safety, effectiveness and quality for all devices. Companies employ scientists, physicians, engineers, quality experts and other professionals to research and examine every aspect of a medical device to ensure that it performs as intended.

Medical technology companies also meet stringent requirements set by FDA, whose oversight is considered the gold standard for regulation worldwide. FDA regulations cover the entire lifecycle of a medical technology – from design to manufacture to distribution – to assure that patients have access to safe, effective, and high-quality devices.   

Patient Safety is the Medical Device Industry's #1 Priority

There are many protections in place to ensure devices are safe. 

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Ensuring Safety Throughout Development

Before any device reaches the market, it is rigorously evaluated for safety and effectiveness. Companies devote enormous time and resources to developing and improving technologies, and FDA subjects thousands of devices to extensive science-based reviews every year.

Because medical devices vary in complexity, technological characteristics and patient impact, FDA has developed a risk based premarket review system that determines the level of evidence and review based on the device type. 

Premarket Requirements 

Continued Safety in the Field

Ensuring safety, effectiveness and quality doesn’t stop once a device is cleared or approved. Companies must monitor and control every facet of production and distribution of their products, gathering feedback on their manufacturing processes and the products themselves. This data is used to make improvements to the device and to develop new devices.

FDA's requirements for adverse event reporting and product recalls complement manufacturers’ postmarket oversight. These requirements help provide continued safeguards for patients long after a medical technology is on the market.

Postmarket Requirements