{"id":"https://openalex.org/W3011180834","doi":"https://doi.org/10.5220/0009372903290336","title":"Practices and Requirements of Stakeholders Involved in the Clinical Evaluation of Innovative High-risk Medical Devices: A Qualitative Study","display_name":"Practices and Requirements of Stakeholders Involved in the Clinical Evaluation of Innovative High-risk Medical Devices: A Qualitative Study","publication_year":2020,"publication_date":"2020-01-01","ids":{"openalex":"https://openalex.org/W3011180834","doi":"https://doi.org/10.5220/0009372903290336","mag":"3011180834"},"language":"en","primary_location":{"id":"doi:10.5220/0009372903290336","is_oa":true,"landing_page_url":"https://doi.org/10.5220/0009372903290336","pdf_url":null,"source":null,"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies","raw_type":"proceedings-article"},"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.5220/0009372903290336","any_repository_has_fulltext":null},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5059535496","display_name":"Catherine Roussel","orcid":null},"institutions":[{"id":"https://openalex.org/I154526488","display_name":"Inserm","ror":"https://ror.org/02vjkv261","country_code":"FR","type":"government","lineage":["https://openalex.org/I154526488"]},{"id":"https://openalex.org/I4210100476","display_name":"Clinical Investigation Center Plurithematic Tours","ror":"https://ror.org/00xzj9k32","country_code":"FR","type":"facility","lineage":["https://openalex.org/I4210100476"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Catherine Roussel","raw_affiliation_strings":["INSERM CIC 1415, University Hospital, Tours, France, --- Select a Country ---"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"INSERM CIC 1415, University Hospital, Tours, France, --- Select a Country ---","institution_ids":["https://openalex.org/I4210100476","https://openalex.org/I154526488"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5075203522","display_name":"Alexandrine Salis","orcid":"https://orcid.org/0000-0001-7490-0675"},"institutions":[{"id":"https://openalex.org/I154526488","display_name":"Inserm","ror":"https://ror.org/02vjkv261","country_code":"FR","type":"government","lineage":["https://openalex.org/I154526488"]},{"id":"https://openalex.org/I4210167250","display_name":"French Clinical Research Infrastructure Network","ror":"https://ror.org/05xw0wj25","country_code":"FR","type":"facility","lineage":["https://openalex.org/I4210167250","https://openalex.org/I4405258862"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Alexandrine Salis","raw_affiliation_strings":["INSERM FCRIN UMS 015, University Hospital, Toulouse, France, --- Select a Country ---"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"INSERM FCRIN UMS 015, University Hospital, Toulouse, France, --- Select a Country ---","institution_ids":["https://openalex.org/I154526488","https://openalex.org/I4210167250"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5084748745","display_name":"Sylvia Pelayo","orcid":"https://orcid.org/0000-0003-2830-2548"},"institutions":[{"id":"https://openalex.org/I154526488","display_name":"Inserm","ror":"https://ror.org/02vjkv261","country_code":"FR","type":"government","lineage":["https://openalex.org/I154526488"]},{"id":"https://openalex.org/I2279609970","display_name":"Universit\u00e9 de Lille","ror":"https://ror.org/02kzqn938","country_code":"FR","type":"education","lineage":["https://openalex.org/I2279609970"]},{"id":"https://openalex.org/I3018718406","display_name":"Centre Hospitalier Universitaire de Lille","ror":"https://ror.org/02ppyfa04","country_code":"FR","type":"funder","lineage":["https://openalex.org/I3018718406"]},{"id":"https://openalex.org/I4210150021","display_name":"Centre d'Investigation Clinique - Innovation Technologique","ror":"https://ror.org/04fmayc82","country_code":"FR","type":"healthcare","lineage":["https://openalex.org/I4210150021"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Sylvia Pelayo","raw_affiliation_strings":["Univ. Lille, INSERM, CHU Lille, CIC-IT 1403 - Centre d'Investigation Clinique, EA 2694, F-59000 Lille, France, --- Select a Country ---"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Univ. Lille, INSERM, CHU Lille, CIC-IT 1403 - Centre d'Investigation Clinique, EA 2694, F-59000 Lille, France, --- Select a Country ---","institution_ids":["https://openalex.org/I4210150021","https://openalex.org/I154526488","https://openalex.org/I2279609970","https://openalex.org/I3018718406"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0230617,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":"329","last_page":"336"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13280","display_name":"Biomedical and Engineering Education","score":0.8603000044822693,"subfield":{"id":"https://openalex.org/subfields/2204","display_name":"Biomedical Engineering"},"field":{"id":"https://openalex.org/fields/22","display_name":"Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T13280","display_name":"Biomedical and Engineering Education","score":0.8603000044822693,"subfield":{"id":"https://openalex.org/subfields/2204","display_name":"Biomedical Engineering"},"field":{"id":"https://openalex.org/fields/22","display_name":"Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T14293","display_name":"Biotechnology and Related Fields","score":0.8596000075340271,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.748199999332428,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/qualitative-research","display_name":"Qualitative research","score":0.5173755884170532},{"id":"https://openalex.org/keywords/medical-device","display_name":"Medical device","score":0.4525928795337677},{"id":"https://openalex.org/keywords/risk-management","display_name":"Risk management","score":0.440233051776886},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.40730762481689453},{"id":"https://openalex.org/keywords/risk-analysis","display_name":"Risk analysis (engineering)","score":0.4003337621688843},{"id":"https://openalex.org/keywords/knowledge-management","display_name":"Knowledge management","score":0.3710927963256836},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.3458225131034851},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.22459843754768372},{"id":"https://openalex.org/keywords/biomedical-engineering","display_name":"Biomedical engineering","score":0.1345958411693573},{"id":"https://openalex.org/keywords/sociology","display_name":"Sociology","score":0.08821868896484375}],"concepts":[{"id":"https://openalex.org/C190248442","wikidata":"https://www.wikidata.org/wiki/Q839486","display_name":"Qualitative research","level":2,"score":0.5173755884170532},{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.4525928795337677},{"id":"https://openalex.org/C32896092","wikidata":"https://www.wikidata.org/wiki/Q189447","display_name":"Risk management","level":2,"score":0.440233051776886},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.40730762481689453},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.4003337621688843},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.3710927963256836},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.3458225131034851},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.22459843754768372},{"id":"https://openalex.org/C136229726","wikidata":"https://www.wikidata.org/wiki/Q327092","display_name":"Biomedical engineering","level":1,"score":0.1345958411693573},{"id":"https://openalex.org/C144024400","wikidata":"https://www.wikidata.org/wiki/Q21201","display_name":"Sociology","level":0,"score":0.08821868896484375},{"id":"https://openalex.org/C36289849","wikidata":"https://www.wikidata.org/wiki/Q34749","display_name":"Social science","level":1,"score":0.0},{"id":"https://openalex.org/C10138342","wikidata":"https://www.wikidata.org/wiki/Q43015","display_name":"Finance","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.5220/0009372903290336","is_oa":true,"landing_page_url":"https://doi.org/10.5220/0009372903290336","pdf_url":null,"source":null,"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies","raw_type":"proceedings-article"}],"best_oa_location":{"id":"doi:10.5220/0009372903290336","is_oa":true,"landing_page_url":"https://doi.org/10.5220/0009372903290336","pdf_url":null,"source":null,"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies","raw_type":"proceedings-article"},"sustainable_development_goals":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W1923764247","https://openalex.org/W2114208415","https://openalex.org/W2369233745","https://openalex.org/W2125534874","https://openalex.org/W2611614597","https://openalex.org/W2313821829","https://openalex.org/W2619501344","https://openalex.org/W4386500624","https://openalex.org/W2899303483","https://openalex.org/W4240788009"],"abstract_inverted_index":null,"counts_by_year":[],"updated_date":"2026-06-11T09:08:48.828518","created_date":"2025-10-10T00:00:00"}
