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Overview of FDA ISO 13485 and 21 CFR Part 820 Harmonization The US FDA (Food and Drug Administration) is known for many things. However, adaptability and the willingness to harmonize with other regulatory agencies worldwide might not be one of them. Nevertheless, in 2018 the FDA began work to reconcile the US regulation on quality […]
AI, XR and Data: Manufacturing Technology Predictions for 2024 If we’re finished with the hype cycle, we’re probably talking about a technology that’s here to stay. So, when IndustryWeek asks manufacturers and analysts for their predictions about manufacturing technology in the coming year, we’re looking for the most mature technologies with the widest adoption rates. […]
Bridging the Gap in Insurance Product Development: How Jama Connect® Can Streamline Requirements Management In an industry as longstanding, complex, and regulated as insurance, it’s easy for inefficiencies to creep in. Companies use the same old systems and processes that others have used for decades, and in the crunch to manage the day-to-day business, the […]
How Can Technology Advance Our Lean Effort? Lean has played a significant role for the past few decades in driving efficiency across manufacturing organizations by providing people with the data and methods for eliminating waste, improving factory flow, and focusing on customer value. Lean techniques have promoted simple, intuitive visual and analytical approaches to decision-making, […]
Foreward by Josh Turpen – Chief Product Officer, Jama Software® A big “Thank You!” to Chris Dickens for a great article. As part of our security program here at Jama Software, we have a layered approach to security tests and scans. Scans are done on every build, automated tests are run on every build, and […]
Leading Quantum Computing Company, IonQ, Selects Jama Connect® to Decrease Review Cycles, Reduce Rework, and Improve Communication and Collaboration With a return on their investment in less than six months, the IonQ team is confident they made the right selection. About IonQ: Founded in 2015 by Chris Monroe and Jungsang Kim to “build the world’s […]
Q&A: How Monogram’s CEO plans to disrupt robotic joint replacement surgery The robot developer’s CEO, Benjamin Sexson, tells MedTech Dive why he believes the orthopedics market needs a fresh approach to joint reconstruction. Seven-year-old surgical robotics company Monogram Orthopedics, which went public in May, is aiming to take on medtech heavyweights such as Stryker and […]
MDR/IVDR Survey Shows Notified Bodies (NBs) Have Increased Capacity A recent survey published by the European Commission shows a promising trend for devices and diagnostics transitioning to Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) but it’s still too early to say how successful the transition is going, two experts told Focus. The […]
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Reuters, titled “EU Seals New US Data Transfer Pact, But Challenge Likely” – originally […]
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Beyond Type 1, titled “Tandem’s Mobi Approved by the FDA” – originally written by […]