In September 2022, the FDA ushered in a groundbreaking transformation in the medical device industry by unveiling a new draft guidance on software validation titled "Computer Software Assurance for Production and Quality System Software."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...
Application Lifecycle Management (ALM) tools are the difference between streamlining development processes, maintaining regulatory compliance, and enhancing collaboration….or falling flat on your face. There are plenty of ALM solutions out there that boast they will...
At SPK, we specialize in supporting companies to accelerate their product development. And, one key aspect of that is redefining the role of unit testing in the development process. Essentially, the way you approach testing can greatly impact the success of your...
In a year of unexpected twists, the medical technology (MedTech) industry finds itself amidst shifting sands. So, Greenlight Guru’s 2023 MedTech Industry Benchmark Report is a treasure trove of insights into MedTech trends and the landscape. Let's deep dive into some...
Numbers rarely lie, and in the case of GitLab, the figures are compelling. With a user base exceeding 30 million, GitLab isn’t just another name in the DevOps arena. It's a behemoth. And, in 2023, GitLab’s DevOps platform was named a Leader in the Gartner Magic...
Managing requirements can feel like a flawed game of telephone—messages get distorted by the time they reach their destination. This doesn't just waste time and resources, but puts the entire project at risk. Legacy tools often fall short in meeting modern project...
In this video, Carlos Almeida, Vice President of Engineering at SPK and Associates will show you how to master release management. And, how to do it by creating versioned artifacts in Codebeamer. You can watch the video as he walks through the step-by-step tutorial....
Are you a medical device manufacturer seeking to overcome the challenges of your current quality management? Let me help you show you the light. In this blog, we will show you the advantages of adopting an Enterprise Quality Management System (eQMS). Better yet, one...
Hello, this is Carlos Almeida from SPK and Associates. Today, we're going to talk about the PTC Codebeamer Jira integration. We're going to take a quick look. You can watch the video above, or follow the transcript below. Jira and Codebeamer Integration The Jira...
In the rapidly growing ALM (Application Lifecycle Management) market, your business is likely striving for efficient collaboration and timely software delivery. Codebeamer and Jama Connect are often compared with our own clients. So, we’ve put the two, head-to-head...
PTC LiveWorx is the premier event bringing together professionals and innovators from various industries. It ignites the exploration of digital transformation, industrial innovation, and emerging technologies. From engaging keynote presentations to hands-on workshops...
Medical device companies face complex quality management challenges and strict regulatory requirements. An electronic quality management system (eQMS) like Greenlight Guru, can help companies ensure compliance, improve efficiency, facilitate collaboration, and scale...
