AWS, with its commanding market share in the world of cloud, relies heavily on engineering organizations for its success. We’ve explored the reasons for this in previous articles. What it boils down to is that Amazon’s cloud platform is more geared toward the way...
Azure first became associated with IT for one simple reason: It’s a Microsoft product. Since the majority of organizations are running some kind of Microsoft application (be it Windows or Office), it was an easy sell because of ease of integration. However, this alone...
We’ve hinted at it throughout this series, but now we’re going to say it explicitly: To get the most out of the cloud you should be combining solutions. At the very least, you should be thinking more flexibly than “AWS is for engineering, Azure is for IT.” Does Your...
Last time we discussed how a multi-cloud solution including both AWS and Azure might be just the solution your organization needs. Now let’s talk a bit more about the challenges attendant to leveraging both platforms at the same time. Architecting both to play nice...
Of course, the missing piece of our cloud discussion is Google Cloud. In some ways, Google is a minor player in the cloud world, despite popular cloud-based apps like Google Docs and Google Drive. It’s not even in third place -- it’s in fourth, behind IBM. The...
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.
Today’s clients are global -- and today’s content is rich. Without adapting to the use of modern tools, dynamic content can slow down the performance of your website, frustrating your potential customers. The problems of hosting international sites are well known:...
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...