AssurX’s picture

By: AssurX

The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on real-world evidence (RWE).

AssurX’s picture

By: AssurX

The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.

Rob Mitchum’s picture

By: Rob Mitchum

People have touted the potential of big data and computation in medicine for what feels like decades, promising more effective and personalized treatments, new research discoveries, and smarter clinical predictions. But only recently have these technologies made it to the clinic, where they can actually improve patient care.

Azadeh Shoaibi’s picture

By: Azadeh Shoaibi

The word “prism” might make you think of a triangular piece of glass that separates white light into a rainbow of colors. But at the U.S. Food and Drug Administration (FDA), it means a powerful, computer-based system that separates critical bits of information from vast streams of healthcare data in order to investigate adverse events and determine if there is a connection to a specific vaccine.

Multiple Authors
By: Brenda Stodart, Renu Lal

It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.

Jon Speer’s picture

By: Jon Speer

If you’re in the medical device industry, you may think that design controls are a confusing imposition on your processes. But they’re a necessary part of your requirements as a medical device developer, and I’ve noticed that this area tends to be rife with misconceptions, confusion, and generally making things into a bigger deal than they really need to be.

Multiple Authors
By: Suzanne Junod, John Swann

The U.S. Food and Drug Administration’s (FDA) “History Vault” contains more than 10,000 artifacts that provide a journey through U.S. history and document the critical role played by one of the nation’s oldest public health agencies during its mission to promote and protect American health.

AssurX’s picture

By: AssurX

Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.

Jon Speer’s picture

By: Jon Speer

If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not only provides a needed function to a patient, but is also proven to be safe to use—maybe even used by someone who is near and dear to you.

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