The Unified Write Filter (UWF) is a Windows native feature that ensures a system’s data remains as an unmodified, secure baseline. Data can be changed by a Windows UWF system user. However, the changes do not persist after a restart. In fact, changes are discarded...
Cybersecurity
Computer Systems Validation: How To Avoid FDA Warning Letters C.F.R. 820.70(i)
Computer systems validation (CSV) is a standard regulatory exercise Med Device companies are required to complete. This is not new news. In fact, the content in this article may not be “new news” for you either, but as with other regulatory requirements, it’s useful...
9 Things You Need To Know About Cybersecurity and Protected Health Information (PHI) breaches
In the past 18 months, there have been breaches of security related to protected health information (PHI) at Broward Health, Florida Healthy Kids, and the Accellion FTA Hack. In turn, these breaches resulted in 11 more healthcare organizations getting exploited. ...
5 Best Practices That Could Have Protected You From Log4J
Log4j: What Is It? On December 9, 2021, a critical exploit named "Log4j" was disclosed to the world. This exploit was particularly harrowing due to the fact that the software library which it targeted is so widely utilized. “Log4Shell” (CVE-2021-44228,...
Accelerating Product Development with Engineering Operations
What is Engineering Operations (EngOps)? Why do you need it, and how do you effectively deploy it?There’s a strange interplay between IT and engineering teams in most firms. That’s because the tech stack that engineers need to design, build, test, and release products...
8 Myths About Moving To The Atlassian Cloud Debunked
"Oh, the Atlassian Cloud isn't built for Enterprise." As an Atlassian Solution Partner, we’ve seen that most organizations who are hesitant about moving to cloud, aren’t equipped with the right information. This is why we’ve busted the top cloud myths. In this...
How AWS Cloud Solutions Can Help Your Manufacturing Enterprise Maintain Its Competitive Edge
Executive Summary In 2020, public and private cloud-based solutions like Amazon Web Services surpassed traditional data centers in terms of overall spending. In 2017, nearly two thirds of spending went toward private cloud solutions. Cloud usage exploded in 2017, to...
How Microsoft Azure Cloud Solutions Can Help Your Manufacturing Enterprise Maintain Its Competitive Edge
Executive Summary In 2020, public and private cloud-based solutions are set to surpass traditional data centers in terms of overall spending. In 2017, nearly two thirds of spending went toward private cloud solutions like Microsoft Azure. Cloud usage exploded in 2017,...
Navigating Compliance and Cyber Security Concerns in Smart Medical Devices
A COMPLETE OVERVIEW OF SMART MEDICAL DEVICES, THEIR DEVELOPMENT AND THEIR COMPLIANCE CONSIDERATIONS. While the Internet of Things offers great opportunities both for businesses and consumers, compliance and security must be thought through carefully from the very...
How Cyber Security Requirements Can Throw your Medical Device Off Track
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...
Four Steps to Securing Your Company’s Medical Devices
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...
Security and Compliance – What Your Company Needs to Know Part 2: MBSA
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...