In 2025, medical device manufacturers are grappling with heightened regulatory uncertainty, leading to slower reviews and communication difficulties with the FDA. This situation drives them to reassess operations for compliance and risk management, with a strong emphasis on maintaining product quality, which is vital for patient safety.
Musashi AI will introduce the latest updates to our Cendiant® Inspect turnkey AI software and our Automated Shaft Inspector at Automate 2025 in Detroit, May 12-15.
Quality assessments of parts often rely on a "yes" or "no" on a printed report, a "good" part versus "bad." However, advancements like 3D scanning allow engineers to visualize and analyze surface textures, revealing crucial insights beyond basic roughness values, which is vital for meeting increasing performance demands.
Periodic analysis in manufacturing is essential to avoid complacency and adopt the latest techniques. If corrective actions or improved training can reduce costs and enhance quality, it's time to make those investments.
America Makes, the National Additive Manufacturing Innovation Institute, recognizes the urgent need for education and workforce development initiatives.
The U.S. manufacturing supply chain faces challenges, especially for small- to medium-sized manufacturers (SMMs) in additive manufacturing. To tackle talent shortages, America Makes has partnered with organizations to develop education and workforce initiatives to enhance SMM capabilities and competitiveness.
Risk assessment is not a one-time exercise but a continuous cycle that must adapt to changes in organizational context, industry regulations, and emerging threats.
This article highlights the importance of risk management in Conformity Assessment Bodies (CABs). It discusses key principles and tools to help CABs identify and mitigate risks, enhancing resilience and assessment accuracy. Read one to see what practical insights are offered for integrating risk management into CAB operations.
Waygate Technologies, a Baker Hughes business and global leader in nondestructive testing (NDT) solutions for industrial inspection, unveiled its new extremely high-resolution computed tomography (CT) system, Phoenix Nanotom® HR (High Resolution).
Unlock the power of reflective self-talk to enhance your productivity and drive continuous improvement. Explore its benefits and discover practical strategies to integrate this transformative practice into your daily routine.