Experienced mechanical engineer with extensive history as a technical writer for the medical device and regulatory compliance fields. General technology writing experience as well.
Significant writing accomplishments:
•Provided over 30 clinical literature reviews to various clients that were accepted without revision by their respective Notified Bodies. In all cases, the products were approved for sale in the EU based in part upon the demonstrated safety and efficacy as shown by the analysis within the clinical literature review.
•Completed a meta-analysis on 17 indications for use of an intraaortic balloon pump. Indications included cardiogenic shock, septic shock, and myocardial contusions, to name a few. The report covered over twelve years worth of literature and included over 200...