V2018

Connected Devices Summit

Connected Devices: Cybersecurity & Compliance Summit

Is your medical device secure? I learned a lot about the latest trends in cybersecurity and how to protect medical devices and hospitals at a conference this week hosted in San Francisco and featuring presentations by cybersecurity experts from the medical device industry, from hospital systems, and from vendors of security tools. Medical device cybersecurity  …

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Newsletter V. 2018 Issue 2

FDA Software Guidances and the IEC 62304 Software Standard There are two sets of rules for SW regulation—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the IEC 62304 Standard and then include any additional adjustments needed to meet all the FDA requirements. This article details exactly what …

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FDA software guidances

FDA Software Guidances and the IEC 62304 Software Standard

“One approach to satisfy two sets of rules” for FDA software guidances As stated in the last blog post, there are two sets of rules for FDA software guidances—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the IEC 62304 Standard, which is easier to understand, and then …

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Newsletter V. 2018 Issue 1

Beginner’s Guide to Medical Device Software “Medical Device Software for Newbies” or “Why is this stuff so confusing?” This article is designed for people who are new to medical device software—either experienced with software but not medical device regulations or experienced with medical device hardware only. Why is software special? References on medical cybersecurity for …

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