Reliability & Quality
As a medical device manufacturer, you face tremendous challenges, including stringent regulations, competition, consumer advocate groups, product liability lawsuits and their implications. As a result, you must create safe, reliable, and cost-effective products. You also have to manage and reduce risk effectively throughout your product’s life cycle. In other words, you have to balance risk, cost and performance.
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Safety
Job-related injuries affect quality and may have financial impacts as well. A serious injury, which shuts down a line for several hours, can have a dramatic financial and production impact especially as more companies switch to Just-in-Time-Inventory. The manufacturing sector has various job safety standards, including ANSI B1, Robotic Standard (ANSI/RIA R15.06), as well as various EN and JIS standards, to reduce job-related injuries. Despite these standards, in 2002, work-related injuries and illness for all manufacturing industries was 7.2 per 100 full-time workers.
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