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A Strategically Systematic Approach to Acquire Improvement Project Prospects in a Medical Device Company
(Polytechnic University of Puerto Rico, 2012)
Abstract - Numerous companies begin their manufacturing improvement journey lacking an overall game plan. This results in a not strategized and structured improvement implementation with results less than optimal and if ...
Development of a New Medical Device Production Line Using Systems Engineering
(Polytechnic University of Puerto Rico, 2012)
Abstract - The design and development of a production line to manufacture a new medical device for clinical trials requires the establishment of a very precise implementation plan. This is especially important since we are ...
Equipment Validation Standardization for Project Implementation Time Reduction of Automated Manufacturing Platforms
(Polytechnic University of Puerto Rico, 2012)
Abstract - Medical Device regulated industry requires extensive validation work. Using the latest automation technology for the process equipment to eliminate the operator interaction brings the challenge of how fast the ...
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 ...
Development of Bulk Shipping Studies in Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2012)
Abstract ⎯ A bulk shipping study in the pharmaceutical industry consists in monitoring and analyzing the environmental conditions (e.g. temperature and relative humidity) during shipping and transportation of the drug ...
Implementation of Innovative Automated Coating Technology in a Medical Device Facility
(Polytechnic University of Puerto Rico, 2012)
Abstract - As part of new products development in a medical device plant, an innovative coating technology known as Physical Vapor Deposition (PVD) will be implemented for the electrode coating process. Current process is ...
Implementing a Preventive Maintenance to Complement Standards 6.3 and 7.1 of ISO 9001:2008
(Polytechnic University of Puerto Rico, 2012)
Abstract - The recycling process turns materials that would otherwise become waste into valuable resources, and it’s know many companies around the world do this process to produce a raw material that will be used to create ...
Guideline for the Development of a Capable Training Program for New Hire Employees in the Design Area of an Aerospace Industry in Puerto Rico
(Polytechnic University of Puerto Rico, 2012)
Abstract - The aerospace industry is very sophisticated since their products and services needs to be in compliance with the highest levels of quality. Since currently this type of industry is new in Puerto Rico most of ...
Manufacturing Expert System Development Guidelines in a Medical Device Manufacturing Company
(Polytechnic University of Puerto Rico, 2012)
Abstract - The medical device manufacturing company as well as other regulated industries can only perform manufacturing activities in a strictly controlled environment working area controlled by complex systems that ...
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 ...