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Determination of In-Processing Manufacturing Impact into Elution Rate of Drug Eluting Steroid Collars
(Polytechnic University of Puerto Rico, 2012)
Abstract - The Food and Drug Administration provides regulations for combination products. The medical device industry needs to comply with these regulations specifically in products containing drug. One of the many ...
Validation of a New Procedure for a Pacemaker Component
(Polytechnic University of Puerto Rico, 2012)
Abstract - Company X manufactures pacemakers in Puerto Rico. Over the past years, Company X has been having a significant amount of complaints due to the septum component contained in its pacemakers. Doctors have claimed ...