Traditional medical devices are quickly going the way of the ear horn for one simple reason: their valuable data is confined to the device. Some have short-term storage capabilities. None, however, capture data over time for long-term analytics or storage. Intelligent...
You need more than just an antivirus and security suite to keep your system safe. You need multiple, non-redundant solutions covering various aspects of network security. In our last blog, we discussed the role of whitelisting in keeping your network secure. Now we’re...
The Internet of Things is revolutionizing the medical device field. However, it’s also introducing new compliance headaches. What’s more, large-scale medical hacks loom large in the background. Medical device manufacturers can’t ignore the Internet of Things, but nor...
Security in the 21st century is a complicated game. The good guys are always playing catch up with the bad guys. Security is particularly important for medtech companies due to their specific compliance needs. Banking and fintech likewise have a high bar for security...
By the end of this white paper you will be well informed regarding the advantages and setbacks of IoT solutions for medical device product development. The use of IoT in Medical Devices is a complex and highly relevant topic. This white paper will: Explore intelligent...
Connected medical devices offer enormous opportunity for manufacturers and consumers alike. They also carry the burden of increased risk due to cybersecurity flaws. Think about the dangers of having your email or bank account hacked. Now consider the damage hacking a...
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...