SentinelOne is an endpoint security tool. It offers cybersecurity protection for platforms including laptops, PC, phones, cloud servers and identity server protection. And it is the next generation in vulnerability endpoint protection platform (EPP). SentinelOne is...
Cybersecurity
SPK Accelerates Fortune 100 MedDevice Product Sale
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...
Use Nessus To Harden Your Cybersecurity
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...
Protecting Device Storage Using Windows UWF
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: 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...
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,...
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. ...
Podcast: Can IoT Jump These Five Hurdles? Episode 3 – IOT Device Serviceability and Environmental Impacts
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...
PLM in the Cloud: Computer System Validation in FDA Regulated Industries
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...
Security layers on a modern website
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...
Podcast: Can IoT Jump These Five Hurdles? Episode 2 – Sensor Interfaces and Smart Devices
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...
Cyber Security in Medical Device Design
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...