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.

Anna Nagurney’s picture

By: Anna Nagurney

When we talk about supply chains, we may conjure up images of manufacturing plants, warehouses, trucks, and shipping docks. There is another, truly unique supply chain for a product vitally important to healthcare and life, and it is very volatile at the moment: the blood supply chain.

Dara Corrigan’s picture

By: Dara Corrigan

For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern.

AssurX’s picture

By: AssurX

Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the agency will focus like a laser on CAPA.

Suzanne Schwartz’s picture

By: Suzanne Schwartz

During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to the technology we rely on every day, including helping patients remain confident in the safety of their medical devices.

Joel Bradbury’s picture

By: Joel Bradbury

Healthcare professionals have a long history of caring for their patients and improving the quality of their services. During the Crimean War (1853–1856), British nurse Florence Nightingale realized that the mortality rate of soldiers was far too high. A visionary statistician as well as a talented nurse, she spent months analyzing data to identify what caused the high rate of mortality. She found that hygiene and sanitization were neglected in the triage and care of the soldiers.

Michael Causey’s picture

By: Michael Causey

Brooke Pierce’s picture

By: Brooke Pierce

When Congress passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), “risk” moved front and center as a feature of provider reimbursement models. These days, terms such as “at risk” and “risk-based” are used more and more, but what do they really mean? And why should healthcare providers now be more concerned with risk than they have been in years past?

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