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History of the Quality Management System

History of the Quality Management System

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...

The FDA’s Adoption of ISO 13485: What Medical Device Manufacturers Should Know

The FDA’s Adoption of ISO 13485: What Medical Device Manufacturers Should Know

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...

How Hardware Startups Can Achieve Long-Term Success

How Hardware Startups Can Achieve Long-Term Success

Research shows that 97% of hardware startups fail because they didn’t deliver their product on time, there was a lack of consumer demand, a high burn rate, product strategy mistakes, or regulatory uncertainty.1 Hardware product companies produce a broad range of advanced hardware and equipment ranging from medical devices, battery technology, and cyber-electronics to home appliances, networking...