Content by Russ King

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Russ King
As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because...
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Russ King
The path to medical device commercialization requires FDA approval, which most often means filing a premarketing notification, also known as a 510(k). The FDA has specific criteria for accepting a...
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Russ King
The FDA just issued a Safety Communication on the cybersecurity vulnerabilities of the Hospira Symbiq Infusion System, which is a computerized pump designed for the continuous delivery of...
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Russ King
IEC 62304, the international standard that defines software development life-cycle requirements for medical device software, was developed from the perspective that product testing alone is...
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Russ King
Food and Drug Administration (FDA) medical device recalls are on the rise. An increasingly active FDA coupled with an increase of medical device software components is adding up to new challenges...
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Russ King
The FDA recently released a new draft guidance document for medical device data systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and...