Interview with Todd Dunsirn, CEO, True Process
A while back I had the opportunity to chat with Todd Dunsirn, the CEO of True Process. True...
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Tag: MDDS
HIMSS 2014 in Review
The HIMSS conference is so big, with so many different kinds of attendees and exhibitors that it's...
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Defining the Point of Care Market
It's useful to segment and analyze markets for developing company and product strategy or...
Read MoreFinal MDDS Rule Signals FDA Shift to Enforcement
The real news behind the final rule is FDA’s stated intent to exercise “enforcement discretion.”
Read MoreCanada Posts “Medical Device Data System” Rule
Any software that receives and manipulates patient data is a medical device.
Read MoreFinal MDDS Rule Expected Soon
One should not mistake past regulatory discretion for lackadaisical enformcement on the part of the FDA.
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Facing FDA Regulations for the First Time
What are your risks in being part of a regulated device, and what can you do to make yourself a more attractive supplier?
Read MoreFDA MDDS Webinar
As 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 MoreWhat’s Wrong with the Proposed FDA MDDS Rule
It is foreseeable… that an MDDS could initiate a command to a medical device that results in unintended operation of the device.
Read MoreFDA Issues New Draft MDDS Rule
Besides the obvious question of whether the FDA is really serious about regulating MDDS, a few things jump out as areas that need clarification.
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Device/EMR Integration - Basic Components, Market Segmentation
As a follow on the post EMR Adoption and Medical Device Connectivity, let’s look at...
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