Design Control Process - Search Videos

What is the design control process and how has it changed?

The FDA first mandated that medical device manufacturers implement design controls in 1996. The process was copied from Health Canada and the ISO 9001:1994 Standard. Today, people are still teaching the “Waterfall” diagram, but the design of medical devices was never a linear process. The V-diagram from IEC 62304 is closer to the real ...

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