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Today, many medical device companies are realizing the benefits of investing in an enterprise quality management system (eQMS) as they look to comply with stringent regulations and introduce safe, life-enhancing products to market. Yet oftentimes they are reluctant to make the leap due to employees’ aversion to change and comfort level with using manual or paper-based systems. We asked Arena...
When asked about the birth of today’s quality management system (QMS), the Toyota Production System (TPS) and lean are probably the first thoughts that come to mind. Although these manufacturing approaches have contributed significantly to process improvement and quality management, there’s a lot more history behind how QMS got its start. Here we travel back in time to explore the true origin of...
A Global Quality System Standard As globalization of medical device supply chains has continued to increase, regulatory bodies have grappled with how to bridge the gap between domestic and foreign regulation. Without a unified approach to both, the daily practice of ensuring that regulatory processes are followed and properly documented is even more challenging. The announcement that the FDA...
