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As a result of intense global competition, Medical Device manufacturers are finding they must boost innovation while facing some new and highly complex business challenges, including global product development, outsourcing of design and manufacturing, and the need to update product development technology. And, while dealing with these tough issues, they must continue complying with strict regulatory requirements imposed by governing agencies around the globe. The most pressing issue that many Med Device makers are facing in product development started just over a decade ago. In 1997, the US Federal Drug Administration (FDA) presented the 'Waterfall' model as a tool for introducing new product design controls.
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