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Comparison of the Quality System Requirements of Code of Federal Regulations Part 820 and International Standard ISO 13485
(Polytechnic University of Puerto Rico, 2010)
This paper compares the quality system requirements of the Code of Federal Regulations 21 CFR part 820 with the quality system requirements of the International Standard ISO 13485. The medical devices industry that distributes ...
Reduce Scrap Loss of a Pacemaker Lead Applying Lean-Six Sigma
(Polytechnic University of Puerto Rico, 2010)
A pacemaker is an electronic device that is placed under the skin to help control abnormal heart rhythms. It consists of a battery, a computerized generator, and lead (wires) with electrodes on one end. in a pacemaker leads ...
Faster Sample Delivery to the Microbiology Laboratory using Lean Six Sigma
(Polytechnic University of Puerto Rico, 2010)
This article presents the Lean Six Sigma tools used to identify the factors that impact the timely arrival of environmental water samples to a Microbiology Laboratory in a biotechnology industry. The inherent variations ...
Klein, Naomi. La batalla por el paraíso: Puerto Rico y el capitalismo del desastre.
(Polytechnic University of Puerto Rico, 2018)
Reseña del libro: La batalla por el paraíso: Puerto Rico y el capitalismo del desastre, por Dra. Omayra Rivera Crespo.
Incremento del proceso productivo, línea PMK1 en Edwards Lifesciences, Santo Domingo, R. D. Mediante las herramientas de Lean Manufacturing
(Universidad Politécnica de Puerto Rico, 2020)
El objetivo de este proyecto fue investigar el proceso productivo o "productividad" de la línea PMK1, de Edwards Lifesciences en Santo Domingo, República Dominicana, para proponer mejoras apropiadas con un alto impacto del ...
Registros de Calidad en la Industria de Dispositivos Médicos: Uso Electrónico o Manual/Papel
(Universidad Politécnica de Puerto Rico, 2020)
ste reporte intenta comprobar planteamientos relacionados a ventajas del uso de los registros electrónicos versus los registros manuales/papel en empresas de dispositivos médicos, al identificar indicadores clave del negocio ...
Productivity Increase by Means of Critical Process Automation for Edwards Lifesciences
(Universidad Politécnica de Puerto Rico, 2020)
Due to the boom in exports of medical devices, the effort to maintain product quality has increased, but productivity has remained unchanged. In the free zone industries, direct labor is one of the variation factors that ...
Impacto de la Terminación de las Superficies del Material Base Para la Adherencia en el Proceso de Sobremoldeo
(Universidad Politécnica de Puerto Rico, 2020)
El sobremoldeo consiste en el moldeo por inyección de una sustancia sobre otra. El propósito de estas tecnologías es producir componentes multifuncionales con una variedad de colores y/o materiales y unir las características ...
Changeover Process Optimization for a Medical Device Manufacturer in Haina, Dominican Republic
(Universidad Politécnica de Puerto Rico, 2020)
The medical device industry has the critical mission of saving and sustaining lives of patients being affected by chronical diseases. To these companies, having more available time to produce will enable and facilitate ...
Trane Puerto Rico Contracting Transition Process Improvement
(Polytechnic University of Puerto Rico, 2020)
Trane Puerto Rico has established processes for conducting contracting work. The processes in place are adequate in most cases but may need adjustments in others. A case in point is the transition process. Before this ...