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...
What is Computer Systems Validation (CSV)? Additionally, why does the Food & Drug Administration (FDA) require them for the Medical Device industry? More importantly, how can CSVs be efficiently completed and managed? Let’s explore why you can’t skip that...
In Part 1 of this article, we talked about the banking innovation industry threats and market conditions. We discussed how DevOps and CI/CD tools can help to mitigate threats. We also discussed why tools like Jenkins, CloudBees CD/RO and CloudBeesSoftware Delivery...
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...
The Threats and Market Conditions The banking and financial industry faces some tough challenges that many other industries do not. The continually increasing regulations. The continuous threat of cyber-attacks. The disruptive innovation from outside of the sector....
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. ...
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,...
Overview In 2015, SPK and Associates co-founder Chris McHale spoke with Peter Thorne, Director at Cambashi, a Cambridge, England-based independent industry analyst firm. With his over 30 years of experience as a software engineer user, vendor, and now analyst, Peter’s...
https://www.youtube.com/watch?v=Og6826J7EOo Video Transcript: I'm Carlos Almeida, VP of Engineering at SPK and Associates. I've spent most of my professional life doing software engineering. 25 years plus in the world of high tech in the electronic design automation...
The importance of test management, especially in highly-regulated industries, cannot be overstated. Efficient management of testing requirements leads to safer products, effective production, and satisfied customers. The PTC Windchill Requirements Validation &...
An important part of creating any product intended for use in any regulated industry vertical is that the manufacturer should have identified all of the risks involved in using the device. Then, they must have done their best to mitigate those risks before their...
On October 2018, the MITRE Corporation and the Food and Drug Administration released their joint document, Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. This is the new Bible for organizations designing and manufacturing connected...