Our client is Fortune 100 Medical Device manufacturer. SPKAA acts as a product cybersecurity managed service provider for their hospital products which have embedded Windows or Windows OS. Fortune 100 MedDevice Problem For over 10 years, SPK has provided ongoing...
Cybersecurity should be baked into the onset of IT and product development processes. Additionally, treating cybersecurity as an afterthought opens your organization up to vulnerabilities and risk. Therefore hardening your IT product cybersecurity with a tool like...
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...
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...
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...
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...
With the push by big technology players (Cisco, Google, Intel, etc.) towards connectivity in everyday devices, cyber security is becoming more and more crucial. This push is even seen in medical device design as the industry begins to move toward cloud-integrated and...
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...