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Medical Device Assembly Yield Improvement: Application of Quality Foundations
(Polytechnic University of Puerto Rico, 2013)
Quality foundations application is not a
new concept for medical device, manufacturing,
and service industries. The key quality concepts
have origins from the quality pioneers named as
“gurus” Joseph Juran, Deming and ...
Quality Improvement Process for Software Controls in Regulated Industry using Six Sigma Methodology
(Polytechnic University of Puerto Rico, 2013)
A regulated industry at medical
devices company, Software Control practices on
Automated Processes are weak and not
systematized. Several findings were found in past
internal audits related to software revision
changes. ...
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 ...
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 ...
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 ...
Improving Steroid Out Of Specification (OOS) Trending on Pacemaker Lead
(Polytechnic University of Puerto Rico, 2013)
The purpose of this project is to
identify a roots cause and potential factors that
influencing Steroid Out Of Specification Results
(OOS) on pacemaker lead model XYZ. Project
involves Define, Measure, Analyze, Improve ...
Reduction of Cosmetic Defects Due to Criteria Misalignment at a Medical Device Manufacturing Line Using DMAIC Methodology
(2013)
For the last few years, the economy of
Puerto Rico has been negatively affected,
increasing the operational cost of the industries in
the Island. The Pharma / Medical Device industry
is not excluded of this situation. ...
Increase of Manufacturing Line Capacity using Lean Manufacturing on a Medical Device Company
(Polytechnic University of Puerto Rico, 2013)
The competition between Medical
Devices companies is increases every day. Many
medical devices companies are marketing products
that compete between each other. They challenged
to obtain long term contracts to supply ...
Increase Productivity in a Manufacturing Department of a Medical Devices Company
(Polytechnic University of Puerto Rico, 2013)
In all companies the productivity is a
very important metric because is the way to make
sure that we optimize our resources and time. Is the
way to measure if we are manufacturing as
expected and with the required ...
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 ...