Experimental Design, proposal writing, data analysis and such

I recently got a project as an independent consultant. A local company
here developed a small machine to help the patients to recover from a
certain type of muscle disorder, let's call X. They want to test this
machine on real patients and write a report to market this machine.
Although I got a master degree on Statistics long time ago, most of the
work i've done before is on quality control, not the experimental
design side. So could you shed me some light on how to handle this
project, from proposal writing, experiemental design, data analysis and
such. Or could you recommend some websites where I can find some
templates for how to write a proposal and design an experiment etc. I
want to get this project done as professional as possible, like the
reports submit to FDA for drug approval. But of course, in a much
simplified format.

Thanks for your input.

.

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