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...
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.
If you’re like many SMBs, IT infrastructure is not your favorite topic. You think about it when you have to, which means that it often becomes neglected, lagging behind other capital investments. What’s more, there’s a good chance your current IT  solutions are...
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Is PLM in the cloud actually delivering new user experiences? According to PLM expert Oleg Shilovitsky that answer is no. He believes PLM companies need to stop marketing cloud technology and start deploying new user experiences in the cloud. SPK and Associates...
You likely know your company's IT infrastructure must be upgraded soon. However, you may be avoiding it due to perceived cost or difficulty. The good news is that you don’t have to make large capital expenditures to expand and update your IT infrastructure. Hybrid...
How SPK was able to unify globally dispersed engineering teams to work, and communicate, in real-time. THE CLIENTA leading medical device manufacturer was facing a problem common to firms with growing engineering operations: As their product-development team grew,...