Publicação
Medical device specificities: opportunities for a dedicated product development methodology
| Resumo: | The medical sector, similarly to other industries such as the aviation industry, has to comply with multiple regulations, guidelines and standards. In addition, there are multiple defi nitions for the expression ‘medical device’, and before entering the market, manufacturers must demonstrate their product’s safety and effectiveness. In such a complex and demanding environment, it is crucial to know the particularities surrounding the product being developed in order to minimize the chances of a commercial fl op. Thus, in this paper, medical device specifi cities are identifi ed, and the most relevant legislation is reviewed providing the foundations for a dedicated product development methodology. |
|---|---|
| Autores principais: | Santos, Isa C. T. |
| Outros Autores: | Gazelle, G. Scott; Rocha, L. A.; Tavares, João Manuel R. S. |
| Assunto: | Medical device characteristics Product regulatory approval Europe Global Harmonization Task Force regulations standards USA |
| Ano: | 2012 |
| País: | Portugal |
| Tipo de documento: | artigo |
| Tipo de acesso: | acesso restrito |
| Instituição associada: | Universidade do Minho |
| Idioma: | inglês |
| Origem: | RepositóriUM - Universidade do Minho |
| _version_ | 1867438608218062848 |
|---|---|
| author | Santos, Isa C. T. |
| author2 | Gazelle, G. Scott Rocha, L. A. Tavares, João Manuel R. S. |
| author2_role | author author author |
| author_facet | Santos, Isa C. T. Gazelle, G. Scott Rocha, L. A. Tavares, João Manuel R. S. |
| author_role | author |
| contributor_name_str_mv | RepositóriUM - Universidade do Minho |
| country_str | PT |
| creators_json_txt | [{\"Person.name\":\"Santos, Isa C. T.\"},{\"Person.name\":\"Gazelle, G. Scott\"},{\"Person.name\":\"Rocha, L. A.\"},{\"Person.name\":\"Tavares, João Manuel R. S.\"}] |
| datacite.contributors.contributor.contributorName.fl_str_mv | RepositóriUM - Universidade do Minho |
| datacite.creators.creator.creatorName.fl_str_mv | Santos, Isa C. T. Gazelle, G. Scott Rocha, L. A. Tavares, João Manuel R. S. |
| datacite.date.Accepted.fl_str_mv | 2012-03-01T00:00:00Z |
| datacite.date.available.fl_str_mv | 2012-12-05T17:18:30Z |
| datacite.date.embargoed.fl_str_mv | 2012-12-05T17:18:30Z |
| datacite.rights.fl_str_mv | http://purl.org/coar/access_right/c_16ec |
| datacite.subjects.subject.fl_str_mv | Medical device characteristics Product regulatory approval Europe Global Harmonization Task Force regulations standards USA |
| datacite.titles.title.fl_str_mv | Medical device specificities: opportunities for a dedicated product development methodology |
| dc.contributor.none.fl_str_mv | RepositóriUM - Universidade do Minho |
| dc.creator.none.fl_str_mv | Santos, Isa C. T. Gazelle, G. Scott Rocha, L. A. Tavares, João Manuel R. S. |
| dc.date.Accepted.fl_str_mv | 2012-03-01T00:00:00Z |
| dc.date.available.fl_str_mv | 2012-12-05T17:18:30Z |
| dc.date.embargoed.fl_str_mv | 2012-12-05T17:18:30Z |
| dc.format.none.fl_str_mv | application/pdf |
| dc.identifier.none.fl_str_mv | https://hdl.handle.net/1822/21194 |
| dc.language.none.fl_str_mv | eng |
| dc.publisher.none.fl_str_mv | Expert Reviews Ltd |
| dc.rights.none.fl_str_mv | http://purl.org/coar/access_right/c_16ec |
| dc.subject.none.fl_str_mv | Medical device characteristics Product regulatory approval Europe Global Harmonization Task Force regulations standards USA |
| dc.title.fl_str_mv | Medical device specificities: opportunities for a dedicated product development methodology |
| dc.type.none.fl_str_mv | http://purl.org/coar/resource_type/c_6501 |
| description | The medical sector, similarly to other industries such as the aviation industry, has to comply with multiple regulations, guidelines and standards. In addition, there are multiple defi nitions for the expression ‘medical device’, and before entering the market, manufacturers must demonstrate their product’s safety and effectiveness. In such a complex and demanding environment, it is crucial to know the particularities surrounding the product being developed in order to minimize the chances of a commercial fl op. Thus, in this paper, medical device specifi cities are identifi ed, and the most relevant legislation is reviewed providing the foundations for a dedicated product development methodology. |
| dirty | 0 |
| eu_rights_str_mv | restrictedAccess |
| format | article |
| fulltext.url.fl_str_mv | https://repositorium.uminho.pt/bitstreams/7e484a15-77ca-4a61-89f6-cfe28c6a3277/download |
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| identifier.url.fl_str_mv | https://hdl.handle.net/1822/21194 |
| instacron_str | repositorium |
| institution | Universidade do Minho |
| instname_str | Universidade do Minho |
| language | eng |
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| network_name_str | RepositóriUM - Universidade do Minho |
| oai_identifier_str | oai:repositorium.uminho.pt:1822/21194 |
| organization_str_mv | urn:organizationAcronym:repositorium |
| person_str_mv | Santos, Isa C. T. Gazelle, G. Scott Rocha, L. A. Tavares, João Manuel R. S. |
| publishDate | 2012 |
| publisher.none.fl_str_mv | Expert Reviews Ltd |
| reponame_str | RepositóriUM - Universidade do Minho |
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| spelling | engExpert Reviews LtdporThe medical sector, similarly to other industries such as the aviation industry, has to comply with multiple regulations, guidelines and standards. In addition, there are multiple defi nitions for the expression ‘medical device’, and before entering the market, manufacturers must demonstrate their product’s safety and effectiveness. In such a complex and demanding environment, it is crucial to know the particularities surrounding the product being developed in order to minimize the chances of a commercial fl op. Thus, in this paper, medical device specifi cities are identifi ed, and the most relevant legislation is reviewed providing the foundations for a dedicated product development methodology.application/pdfengMedical device specificities: opportunities for a dedicated product development methodologySantos, Isa C. T.Gazelle, G. ScottRocha, L. A.Tavares, João Manuel R. S.HostingInstitutionOrganizationalRepositóriUM - Universidade do Minhoe-mailmailto:repositorium@usdb.uminho.ptrepositorium@usdb.uminho.ptPMID22702261ISSNIsPartOf1743-4440DOIIsPartOf10.1586/ERD.12.32012-12-05T17:18:30Z2012-032012-03-01T00:00:00ZHandlehttps://hdl.handle.net/1822/21194http://purl.org/coar/access_right/c_16ecrestricted accessMedical device characteristicsProduct regulatory approvalEuropeGlobal Harmonization Task ForceregulationsstandardsUSA327251 bytesliteraturehttp://purl.org/coar/resource_type/c_6501journal articlehttp://purl.org/coar/access_right/c_16ecapplication/pdffulltexthttps://repositorium.uminho.pt/bitstreams/7e484a15-77ca-4a61-89f6-cfe28c6a3277/download |
| spellingShingle | Medical device specificities: opportunities for a dedicated product development methodology Santos, Isa C. T. Medical device characteristics Product regulatory approval Europe Global Harmonization Task Force regulations standards USA |
| status | SINGLETON |
| subject.fl_str_mv | Medical device characteristics Product regulatory approval Europe Global Harmonization Task Force regulations standards USA |
| title | Medical device specificities: opportunities for a dedicated product development methodology |
| title_full | Medical device specificities: opportunities for a dedicated product development methodology |
| title_fullStr | Medical device specificities: opportunities for a dedicated product development methodology |
| title_full_unstemmed | Medical device specificities: opportunities for a dedicated product development methodology |
| title_short | Medical device specificities: opportunities for a dedicated product development methodology |
| title_sort | Medical device specificities: opportunities for a dedicated product development methodology |
| topic | Medical device characteristics Product regulatory approval Europe Global Harmonization Task Force regulations standards USA |
| topic_facet | Medical device characteristics Product regulatory approval Europe Global Harmonization Task Force regulations standards USA |
| url | https://hdl.handle.net/1822/21194 |
| visible | 1 |