In our last article we talked about the four steps your organization must go through when designing secure connected medical devices. With the increasing attention paid to product security in this era of connected medical devices, many companies are scrambling to keep...
SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends.  One of the problem areas most often cited in company audits continue to be the CAPA system/program.  This month we will take a look at some of the latest FDA...
This article reviews what an FDA 483 Observation looks like, some of the more common issues flagged in medical device companies, and how to respond.
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When it comes to the Internet of Things (IoT) and connectivity, embedded software security is a top concern for a growing number of manufacturing companies and their software engineers. The worldwide market for embedded security software is forecasted to rise to $2.95...