Quality by design and failure mode and effects analysis applied to the development of electromedical technology: Preliminary results
Quality and risk management have evolved with the advancement of pharmaceutical and technological development in healthcare, allowing greater control of each biomedical device's manufacturing processes. Failure Mode and Effect Analysis (FMEA) has been widely used in healthcare to ensure the qua...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2021-12-01
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| Series: | Measurement: Sensors |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S266591742100266X |
| _version_ | 1818388561481695232 |
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| author | Maria Alexandra Matallana Castellanos Elisabeth Costa Monteiro Daniel R. Louzada |
| author_facet | Maria Alexandra Matallana Castellanos Elisabeth Costa Monteiro Daniel R. Louzada |
| author_sort | Maria Alexandra Matallana Castellanos |
| collection | DOAJ |
| description | Quality and risk management have evolved with the advancement of pharmaceutical and technological development in healthcare, allowing greater control of each biomedical device's manufacturing processes. Failure Mode and Effect Analysis (FMEA) has been widely used in healthcare to ensure the quality of manufactured products. It is dedicated to preventing adverse events or incidents, identifying failures to prioritize risk, and optimizing resources, for better quality in medical devices or equipment. Quality by Design (QbD), in turn, has been applied in the pharmaceutical industry for product quality assurance since the development stage. This work integrates QbD and FMEA for application in the development of electromedical equipment. Preliminary results of the proposed hybrid method applied to the development phase of a low-cost and high-sensitivity magnetic measuring system for metallic foreign bodies' location in patients are presented. |
| first_indexed | 2024-12-14T04:27:48Z |
| format | Article |
| id | doaj.art-40ab8102aceb4920b0e6706be0792dc8 |
| institution | Directory Open Access Journal |
| issn | 2665-9174 |
| language | English |
| last_indexed | 2024-12-14T04:27:48Z |
| publishDate | 2021-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Measurement: Sensors |
| spelling | doaj.art-40ab8102aceb4920b0e6706be0792dc82022-12-21T23:17:09ZengElsevierMeasurement: Sensors2665-91742021-12-0118100303Quality by design and failure mode and effects analysis applied to the development of electromedical technology: Preliminary resultsMaria Alexandra Matallana Castellanos0Elisabeth Costa Monteiro1Daniel R. Louzada2Postgraduate Programme in Metrology, Pontifical Catholic University of Rio de Janeiro, Rio de Janiero, BrazilCorresponding author.; Postgraduate Programme in Metrology, Pontifical Catholic University of Rio de Janeiro, Rio de Janiero, BrazilPostgraduate Programme in Metrology, Pontifical Catholic University of Rio de Janeiro, Rio de Janiero, BrazilQuality and risk management have evolved with the advancement of pharmaceutical and technological development in healthcare, allowing greater control of each biomedical device's manufacturing processes. Failure Mode and Effect Analysis (FMEA) has been widely used in healthcare to ensure the quality of manufactured products. It is dedicated to preventing adverse events or incidents, identifying failures to prioritize risk, and optimizing resources, for better quality in medical devices or equipment. Quality by Design (QbD), in turn, has been applied in the pharmaceutical industry for product quality assurance since the development stage. This work integrates QbD and FMEA for application in the development of electromedical equipment. Preliminary results of the proposed hybrid method applied to the development phase of a low-cost and high-sensitivity magnetic measuring system for metallic foreign bodies' location in patients are presented.http://www.sciencedirect.com/science/article/pii/S266591742100266XElectromedical technologyForeign body locationFMEAMagnetic measurementQbDQuality |
| spellingShingle | Maria Alexandra Matallana Castellanos Elisabeth Costa Monteiro Daniel R. Louzada Quality by design and failure mode and effects analysis applied to the development of electromedical technology: Preliminary results Measurement: Sensors Electromedical technology Foreign body location FMEA Magnetic measurement QbD Quality |
| title | Quality by design and failure mode and effects analysis applied to the development of electromedical technology: Preliminary results |
| title_full | Quality by design and failure mode and effects analysis applied to the development of electromedical technology: Preliminary results |
| title_fullStr | Quality by design and failure mode and effects analysis applied to the development of electromedical technology: Preliminary results |
| title_full_unstemmed | Quality by design and failure mode and effects analysis applied to the development of electromedical technology: Preliminary results |
| title_short | Quality by design and failure mode and effects analysis applied to the development of electromedical technology: Preliminary results |
| title_sort | quality by design and failure mode and effects analysis applied to the development of electromedical technology preliminary results |
| topic | Electromedical technology Foreign body location FMEA Magnetic measurement QbD Quality |
| url | http://www.sciencedirect.com/science/article/pii/S266591742100266X |
| work_keys_str_mv | AT mariaalexandramatallanacastellanos qualitybydesignandfailuremodeandeffectsanalysisappliedtothedevelopmentofelectromedicaltechnologypreliminaryresults AT elisabethcostamonteiro qualitybydesignandfailuremodeandeffectsanalysisappliedtothedevelopmentofelectromedicaltechnologypreliminaryresults AT danielrlouzada qualitybydesignandfailuremodeandeffectsanalysisappliedtothedevelopmentofelectromedicaltechnologypreliminaryresults |