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Validation Machine Process of “Crosslink, Low Profile Break-off” On Tornos Deco 20
(Polytechnic University of Puerto Rico, 2016)
The United States (U.S.) medical
device manufacturing sector is a highly diversified
industry that produces a range of products
designed to diagnose and treat patients in
healthcare systems worldwide. Process validation
is ...
Tracking System for Useful Life of an Insulin Pump Motor
(Polytechnic University of Puerto Rico, 2016)
This research project was focused in
the implementation of a Tracking System for the
useful life of an infusion pump’s motor. This
component is a sub-assembly of the infusion pump
which is used to deliver fluids into ...
Workmanship Error at Assembly Line in a Medical Device Company
(Polytechnic University of Puerto Rico, 2012)
Abstract — In a Medical Device Company a production line had an increase of non-conformances in 2011. The category for the increase was workmanship error. These failures result in cost of poor quality due to quality holds. ...
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. ...
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 ...
Finished Goods Failure Reduction in a Wound Closure Medical Device Product Family
(Polytechnic University of Puerto Rico, 2013)
A corrective action and preventive
action plan was developed to address the increase
of Finished Goods failures in a wound closure
medical device product family. Following a DefineMeasure-Analyze-Improve-Control Six ...
PPAP Process and Correlation Study for Vision Systems
(Polytechnic University of Puerto Rico, 2021)
The Production Part Approval Process (PPAP) is being adopted by Medical Device companies to qualify raw material. To standardized qualification processes between multiple supplies and help ...
Anti-inflammatory Drug Elution Rate Variability Reduction
(Polytechnic University of Puerto Rico, 2013)
This project was focused in the Drug
Elution Rate Variability of an Anti-inflammatory
Drug used in a Medical Device Company. The
project is based on the manufacturing and bonding
process of a DXA Drug Collar that is a ...
Quality Improvement in a Medical Device Manufacturing Process Applying Six Sigma Tools
(Polytechnic University of Puerto Rico, 2009)
Abstract - The current manufacturing process of a medical device product has great opportunities on scrap percent reduction, which has been impacting the material and labor costs of the product, as well as in defects per ...