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pleiad devices
3rd floor, 125 cambridgepark drive
cambridge  MA  02140
USA		 europe
pleiad devices
balmoral suite  royal british house
leonard street  perth  ph2 8ha
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Clinical Evaluations and Literature Reviews

In Europe, the Notified Body will expect to see a clinical evaluation of the device. This may come from a detailed, objective literature review or de novo clinical data or a mixture of both. In the US, a thorough literature review is needed to justify the use of a predicate device in any submission to the FDA. Pleiad performs these literature reviews to the required standards. Feedback to date from clients and NBs is that these reviews are excellent and have achieved success for our clients.