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Getting new medical equipment on the market is only half the struggle in today’s regulatory environment, which is always evolving. Even when devices are released, more work still needs to be done, such as the beginning of post-market surveillance (PMS). The Importance of Post-Market Surveillance in Medical Device Manufacturing Manufacturers of medical devices must carry out post-market...
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...