In this blog we'll explore how the Windows UWF, Unified Write Filter can help protect device storage against product cybersecurity. The Unified Write Filter (UWF) is a Windows native feature that ensures a system’s data remains as an unmodified, secure baseline. Data...
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...
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,...
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. ...
In the third episode of our podcast series "Can IoT Jump These Five Hurdles?”, SPK & Associates' Chief Strategy Officer, Rajiv Mistry, explains the challenges of IOT device serviceability and environmental impacts. To see all published episodes, scroll down this...
SPK and Associates leverage PTC’s Integrity platform to help Medical Device companies develop software efficiently while achieving IEC 62304 compliance.
Product lifecycle management (PLM) systems have evolved from being custom-built, on-premise applications to cloud-based, off-the-shelf solutions. As adoption for PLM in the cloud increases, system validation approaches in FDA/GXP regulated industries have had to...
Predictions are hard to make in any area of life, however short term forecasting is not impossible. Ask a meteorologist for the weather in the next twenty-four hours and you will get a fairly accurate prediction. Ask for the outlook over the next 30 days and you will...
Last time, we looked at a basic website design. Now it’s time to start digging into the details around what’s really being used behind the scenes. This time, we’ll focus on security aspects. When a user starts their browser and connects...
LinkedIn, the social network for professionals, has reported that its user database has been hacked and the encrypted passwords of 6+ million users have been stolen. Even though the password database was encrypted, users with weak passwords could be exposed with...
In the second episode of our podcast series "Can IoT Jump These Five Hurdles?", we transition from a broad introduction of these five hurdles to a deeper dive into each challenge facing the Internet of Things. Let's begin with the smart device itself and it's digital...
Developing new and innovative products is essential for companies to survive and thrive -- however safety can never take a backseat to innovation. That is why many companies, like those in the Medical Devices, Aeronautics and Automotive industries, have strict...
