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The way I see it., page-17

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    Thanks Rev I must say that's been my view of the process, but would have struggled saying it as susinctly. One thing of note is since the PIP catastrophe (Industrial grade silicon boobie implants) a lot of agencies, not limited to medical devices, have been both "timid" in new approvals and, in my view, distracted undertaking time consuming retrospective a covering.
 
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