Author Bio
What You Should Know About The FDA’s New Final Rule On LDTs On May 6, 2024, the U.S. Food and Drug Administration (FDA or the agency) published its highly anticipated final rule, which was formally published in the Federal Register on May 6, revising the regulatory definition of an in vitro diagnostic (IVD) product […]
ENR 2024 Top 500 Sourcebook: Plant Tests Ocean Carbon Dioxide Removal Arup begins feasibility study of commercial-scale facility set for Canada site Engineering has begun on a project its developers say could mark a new foray into ocean-based carbon dioxide removal. The Quebec-based plant would be North America’s first commercial-scale, ocean-based carbon dioxide-removal facility, according […]
Cyberattacks: Safeguarding Contractors It’s every construction firm’s biggest nightmare: criminals taking control of their data and holding them to ransom. Ben Wallbank, Trimble, shares some best practices to mitigate cyberattacks Cybersecurity and cybercrime often conjure up images of hackers in dark hoodies, sneaking in the digital back door. In reality, nearly 90% of corporate cybercrime, […]
Jama Connect® Strengthens its Lead as the #1 Requirements Management Solution in G2®’s Summer 2024 Report We are thrilled to announce that Jama Connect® has once again been named the overall leader in the G2 Grid® Report for Requirements Management Software for Summer 2024. G2’s rankings are based on authentic user reviews and data gathered […]
Simplify Audit Documentation by Leveraging the Power of an Itemized Database How to enhance efficiency, auditability, and stay ahead of the competition with Jama Connect® for Medical Device Development In the current landscape of medical device and life sciences development — in addition to facing relentless pressures to innovate, remain competitive, and release quality products […]
Integrating AI in AEC/O to Enhance Efficiency AI’s use in the AEC/O industry has the potential to increase sustainability, efficiency, and decision-making, says Nemetschek Group. From ChatGPT to the realm of robotics, AI appears to be everywhere. In the time-honored tradition that follows the introduction of any new major technological leap – from the printing […]
. Navigating the Shift: From Machinery Directive 2006/42/EC to Machinery Regulation EU 2023/1230 Change is inevitable, especially in regulatory frameworks governing industries. In Europe, the transition from the Machinery Directive 2006/42/EC to the new Machinery Regulation EU 2023/1230 marks a significant step forward in ensuring safety, innovation, and harmonization in the machinery sector. This transition […]
IVDR Common Errors: Navigating Notified Body Expectations Explore the notified body process and IVDR technical documentation with experts Margot Borgel, Director of IVD Global Regulatory Affairs at RQM+, and Vincent Balgos, Director of Medical Device Solutions at Jama Software®. You will gain a thorough understanding of these topics and more: The notified body’s approach to […]
How to Overcome Development Challenges: Optimizing Review Cycles for Regulated Industries The nature of regulated industries poses specific hurdles that demand strict procedures and careful consideration. Teams must navigate various difficulties, such as adhering to strict regulations and managing complicated relationships with stakeholders, to deliver top-notch products, software, and systems. Improving the review process is […]
Ensuring Quality and Reliability in Automotive Software Development: An Overview of ASPICE 4.0 ASPICE (Automotive SPICE) 4.0 is a process assessment model tailored specifically for the automotive industry to ensure the quality and reliability of software and system development processes. It is part of the larger ISO/IEC 330xx family of standards and is derived from […]