The recent recall (links below) for McKesson’s Anesthesia Care system raises interesting questions about potential information system failure modes as well as what system/software functions cross the imaginary line between...
Read MoreProviding healthcare monitoring over that infrastructure changes the rules of the game.
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Uncertainty abounds regarding the potential regulation of smartphone apps by FDA and other...
Read MoreThe real news behind the final rule is FDA’s stated intent to exercise “enforcement discretion.”
Read MoreFDA has received 260 reports of health IT-related malfunctions with the potential for patient harm…
Read More…concern for the proliferation of devices using radio technology as well as reliance on consumer grade communication devices.
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The purpose of the workshop is to facilitate discussion…on issues related to safe and effective interoperable medical devices.
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Unfortunately for you, congress did not wish to extend the physician exemption to hospitals.
Read MoreAny software that receives and manipulates patient data is a medical device.
Read MoreOne should not mistake past regulatory discretion for lackadaisical enformcement on the part of the FDA.
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What are your risks in being part of a regulated device, and what can you do to make yourself a more attractive supplier?
Read MoreGulp. This makes the initial R&D costs seem like a bargain.
Read MoreAs the FDA grinds through the comments submitted in response to their proposed rule for medical device data systems (MDDS), the market awaits the final rule. Regardless of changes between the proposed and final rules, vendors who may be regulated under the new rule will have limited time to prepare. Awhile back, I was contacted […]
Read MoreMore surprising, Cisco has submitted the 7921 wireless handset as a Class I medical device.
Read MoreIt is foreseeable… that an MDDS could initiate a command to a medical device that results in unintended operation of the device.
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