Today digital transformation is top of mind for many manufacturers, as they are forced to compete with novel, disruptive technologies and navigate the new normal of pandemics, part shortages, and other unforeseen events. Companies are reinventing their business practices to mitigate these ongoing disruptions and maintain a competitive advantage. By embracing new digital technologies or software...

Is your business ready to go digital? According to a recent State of Manufacturing survey, 91% of manufacturers reported increased investment in digital solutions across both operations and production to help enhance supply chain resiliency, accelerate innovation, and deal with the long-term effects of the COVID-19 pandemic1. Manufacturing in an Age of Disruption Historically, manufacturers have...

When it comes to commercializing medical devices in the United States, manufacturers must manage many moving parts—from establishing quality management processes and effective design controls to preparing the necessary documentation and clinical evidence for FDA approval. The first step in obtaining FDA approval is classifying your medical device. This is a critical step, as it determines the...