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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...
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...
There is a strong demand for the global transition away from vehicles with conventional internal combustion engines (ICE) toward those with electrified powertrains. The demand is creating greater complexity for original equipment manufacturers (OEMs) and their supply chains. Electric vehicles (EVs) market unit sales are expected to reach 2.13 million vehicles by 2027.1 To meet this target, OEMs...
