For small and medium-sized businesses in the manufacturing industry, hybrid cloud allows for quick and easy integration of what you already have deployed. You also have easier access to new processes, such as the Industrial Internet of Things. This emerging technology...
One SPK financial industry client found it needed to overcome complex cybersecurity compliance demands imposed by the Financial Industry Regulatory Authority and the Securities Exchange Commission. To comply involved automatically collecting data about any...
As humans, we depend on feedback. Everyone likes feedback, whether a glance in the mirror, a friendly compliment or financial reward for a great job. Now thanks to the advancement of medical device design, high tech trends, and use of micro-computers, you can get...
In the past, medical device design focused on a standalone unit or a group of a couple devices that worked together. While that was a great idea, the number of compatibility issues that could occur also blocked connectivity to other devices. With the stream of new...
There was a lot of talk about IPv6 and how it would affect users and IT infrastructure as a whole when we ran out of IPv4 addresses in 2011. Since then, on the consumer and individual level, we have not seen much change. End users still use their IPv4 addresses at...
A possible EMC/VMWare spin off is in the works, which could benefit stock prices and investors, but what about companies relying on VMWare's high availability virtualization software? Would a spin off mean improved technology focus, or a shift in the virtual machine...
SPK wants to wish our growing subscriber community a Happy New Year! We’re honored to be welcomed onto your desktops and smartphones to share stories on how to make your engineering team and company work more efficiently. Perhaps more importantly, we hope any...
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...
Does this sound familiar? Your organization has settled into its cloud migration. You’re enjoying the increased security and resiliency. You feel like you’ve just climbed a mountain and you want to spend some time gazing out from the summit. Then you read about...
On October 2018, the MITRE Corporation and the Food and Drug Administration released their joint document, Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. This is the new Bible for organizations designing and manufacturing connected...
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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