Medical Device Design Control Traceability Using UniDoc

If you are familiar with medical device product development, I’m guessing you’ve seen the FDA Design Control Waterfall diagram. FDA describes Design Controls in a linear fashion: user needs, design inputs, design process, design outputs, design verification, medical device, design validation.

Chances are your product development and design control processes do so as well.

But do medical device projects really follow this linear path?

What if you had the ability to take each individual component through of your medical device product development project through the entire design control process at its own pace? What if you could do this and ensure all Design Controls for that component were documented, traceable, and so on? You don’t have a tool that can do this right now.

UniDoc does this.

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