Mitigating Medical Device Software Risk

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Compliance is easier with proper documentation
arenasolutions   11/29/2011 3:27:41 PM

I agree with your points. One way I think companies can mitigate risk is with a strong focus on compliance and documentation. Truly, there are other industries where you can sort of "get by" with shoddy documentation, but in medical device, that just won't cut it.

Given that companies now develop and store the majority of their business and product information in electronic systems, it follows that documenting changes to that information could be done electronically as well.

We published a white paper intended to help companies who plan to upgrade their paper systems or augment their electronic records management with an electronic change control system that your readers may find useful.

In addition, medical device companies are more "at risk" because of the audits always hanging over their heads. To help with that, we created a white paper - - 5 tips to passing an FDA or ISO audit. Hope that's helpful!

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