The journey from concept to market-ready medical device is no easy feat. The regulatory economy, development and legislation is intricate. Understandably, compliance with standards is non-negotiable to ensure the safety and efficacy of medical devices. One such...
In September 2022, the FDA ushered in a groundbreaking transformation in the medical device industry by unveiling a new draft guidance on software validation titled "Computer Software Assurance for Production and Quality System Software." For years, the medical...
The MasterControl Summit 2023 was an event serving as a hub for professionals, experts, and thought leaders in quality management and regulatory compliance. It offers a platform for knowledge sharing, industry trends, innovation and best practices. Additionally it...
Remote working is an effective way to keep your business running 24/7, mitigate downtime and tap into new markets or expertise. Now, the world is flooded with companies utilizing remote work, digital nomads and gig workers to keep their competitive edge. But, the rise...
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...