{"id":"https://openalex.org/W3210144257","doi":"https://doi.org/10.3233/atde210138","title":"Functional Approach for Summative Risk Management of Medical Products","display_name":"Functional Approach for Summative Risk Management of Medical Products","publication_year":2021,"publication_date":"2021-10-20","ids":{"openalex":"https://openalex.org/W3210144257","doi":"https://doi.org/10.3233/atde210138","mag":"3210144257"},"language":"en","primary_location":{"id":"doi:10.3233/atde210138","is_oa":true,"landing_page_url":"https://doi.org/10.3233/atde210138","pdf_url":"https://ebooks.iospress.nl/pdf/doi/10.3233/ATDE210138","source":{"id":"https://openalex.org/S4210187496","display_name":"Advances in transdisciplinary engineering","issn_l":"2352-751X","issn":["2352-751X","2352-7528"],"is_oa":true,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318577","host_organization_name":"IOS Press","host_organization_lineage":["https://openalex.org/P4310318577"],"host_organization_lineage_names":["IOS Press"],"type":"book series"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Advances in Transdisciplinary Engineering","raw_type":"book-chapter"},"type":"book-chapter","indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"https://ebooks.iospress.nl/pdf/doi/10.3233/ATDE210138","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5068600355","display_name":"Roberto Riascos","orcid":null},"institutions":[{"id":"https://openalex.org/I4210094361","display_name":"Roche Pharma AG (Germany)","ror":"https://ror.org/00sh68184","country_code":"DE","type":"company","lineage":["https://openalex.org/I118019719","https://openalex.org/I4210094361"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Roberto Riascos","raw_affiliation_strings":["Roche Diabetes Care GmbH, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Roche Diabetes Care GmbH, Germany","institution_ids":["https://openalex.org/I4210094361"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5026441009","display_name":"Tomislava Maji\u0107","orcid":"https://orcid.org/0000-0002-7835-4103"},"institutions":[{"id":"https://openalex.org/I1301669915","display_name":"Croatian Academy of Sciences and Arts","ror":"https://ror.org/03d04qg82","country_code":"HR","type":"government","lineage":["https://openalex.org/I1301669915"]},{"id":"https://openalex.org/I4210105025","display_name":"University North","ror":"https://ror.org/01afbkc02","country_code":"HR","type":"education","lineage":["https://openalex.org/I4210105025"]}],"countries":["HR"],"is_corresponding":false,"raw_author_name":"Tomislava Maji\u0107","raw_affiliation_strings":["Croatian Academy of Sciences and Arts in Diaspora and Homeland (HAZUDD), St. Gallen, Switzerland","University North, Koprivnica, Croatia","Croatian Academy of Sciences and Arts in Diaspora and Homeland (HAZUDD), St. Gallen, Switzerland; University North, Koprivnica, Croatia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Croatian Academy of Sciences and Arts in Diaspora and Homeland (HAZUDD), St. Gallen, Switzerland","institution_ids":[]},{"raw_affiliation_string":"University North, Koprivnica, Croatia","institution_ids":["https://openalex.org/I4210105025"]},{"raw_affiliation_string":"Croatian Academy of Sciences and Arts in Diaspora and Homeland (HAZUDD), St. Gallen, Switzerland; University North, Koprivnica, Croatia","institution_ids":["https://openalex.org/I1301669915","https://openalex.org/I4210105025"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5004654369","display_name":"Egon Ostrosi","orcid":"https://orcid.org/0000-0002-5036-4676"},"institutions":[{"id":"https://openalex.org/I37553959","display_name":"Universit\u00e9 de technologie de belfort-montb\u00e9liard","ror":"https://ror.org/05bn3m307","country_code":"FR","type":"education","lineage":["https://openalex.org/I37553959"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Egon Ostrosi","raw_affiliation_strings":["ERCOS/ELLIADD EA4661, Univ. Bourgogne Franche-Comt\u00e9, UTBM, F-90010 Belfort, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ERCOS/ELLIADD EA4661, Univ. Bourgogne Franche-Comt\u00e9, UTBM, F-90010 Belfort, France","institution_ids":["https://openalex.org/I37553959"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5063904684","display_name":"Jean\u2010Claude Sagot","orcid":"https://orcid.org/0000-0002-8969-6096"},"institutions":[{"id":"https://openalex.org/I37553959","display_name":"Universit\u00e9 de technologie de belfort-montb\u00e9liard","ror":"https://ror.org/05bn3m307","country_code":"FR","type":"education","lineage":["https://openalex.org/I37553959"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Jean-Claude Sagot","raw_affiliation_strings":["ERCOS/ELLIADD EA4661, Univ. Bourgogne Franche-Comt\u00e9, UTBM, F-90010 Belfort, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ERCOS/ELLIADD EA4661, Univ. Bourgogne Franche-Comt\u00e9, UTBM, F-90010 Belfort, France","institution_ids":["https://openalex.org/I37553959"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5074126697","display_name":"Josip Stjepandi\u0107","orcid":"https://orcid.org/0000-0003-0877-3799"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Josip Stjepandi\u0107","raw_affiliation_strings":["PROSTEP AG, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"PROSTEP AG, Germany","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":3,"institutions_distinct_count":5,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":1.4309,"has_fulltext":true,"cited_by_count":1,"citation_normalized_percentile":{"value":0.83208955,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":90,"max":94},"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.9843999743461609,"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"}},"topics":[{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.9843999743461609,"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"}},{"id":"https://openalex.org/T14306","display_name":"Technology Assessment and Management","score":0.96670001745224,"subfield":{"id":"https://openalex.org/subfields/2213","display_name":"Safety, Risk, Reliability and Quality"},"field":{"id":"https://openalex.org/fields/22","display_name":"Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/risk-management","display_name":"Risk management","score":0.5997488498687744},{"id":"https://openalex.org/keywords/risk-analysis","display_name":"Risk analysis (engineering)","score":0.5957950353622437},{"id":"https://openalex.org/keywords/process","display_name":"Process (computing)","score":0.5678577423095703},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.567609429359436},{"id":"https://openalex.org/keywords/product-lifecycle","display_name":"Product lifecycle","score":0.5596882104873657},{"id":"https://openalex.org/keywords/summative-assessment","display_name":"Summative assessment","score":0.5406633615493774},{"id":"https://openalex.org/keywords/usable","display_name":"USable","score":0.5242148637771606},{"id":"https://openalex.org/keywords/product","display_name":"Product (mathematics)","score":0.4880582094192505},{"id":"https://openalex.org/keywords/product-life-cycle-management","display_name":"Product life-cycle management","score":0.4374198019504547},{"id":"https://openalex.org/keywords/function","display_name":"Function (biology)","score":0.41484421491622925},{"id":"https://openalex.org/keywords/systems-engineering","display_name":"Systems engineering","score":0.36410582065582275},{"id":"https://openalex.org/keywords/engineering","display_name":"Engineering","score":0.34750187397003174},{"id":"https://openalex.org/keywords/software-engineering","display_name":"Software engineering","score":0.3375436067581177},{"id":"https://openalex.org/keywords/process-management","display_name":"Process management","score":0.3374096751213074},{"id":"https://openalex.org/keywords/new-product-development","display_name":"New product development","score":0.3205288052558899},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.09706541895866394},{"id":"https://openalex.org/keywords/programming-language","display_name":"Programming language","score":0.07515841722488403}],"concepts":[{"id":"https://openalex.org/C32896092","wikidata":"https://www.wikidata.org/wiki/Q189447","display_name":"Risk management","level":2,"score":0.5997488498687744},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.5957950353622437},{"id":"https://openalex.org/C98045186","wikidata":"https://www.wikidata.org/wiki/Q205663","display_name":"Process (computing)","level":2,"score":0.5678577423095703},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.567609429359436},{"id":"https://openalex.org/C194304873","wikidata":"https://www.wikidata.org/wiki/Q1967338","display_name":"Product lifecycle","level":3,"score":0.5596882104873657},{"id":"https://openalex.org/C152747807","wikidata":"https://www.wikidata.org/wiki/Q1854913","display_name":"Summative assessment","level":3,"score":0.5406633615493774},{"id":"https://openalex.org/C2780615836","wikidata":"https://www.wikidata.org/wiki/Q2471869","display_name":"USable","level":2,"score":0.5242148637771606},{"id":"https://openalex.org/C90673727","wikidata":"https://www.wikidata.org/wiki/Q901718","display_name":"Product (mathematics)","level":2,"score":0.4880582094192505},{"id":"https://openalex.org/C7465953","wikidata":"https://www.wikidata.org/wiki/Q1572577","display_name":"Product life-cycle management","level":2,"score":0.4374198019504547},{"id":"https://openalex.org/C14036430","wikidata":"https://www.wikidata.org/wiki/Q3736076","display_name":"Function (biology)","level":2,"score":0.41484421491622925},{"id":"https://openalex.org/C201995342","wikidata":"https://www.wikidata.org/wiki/Q682496","display_name":"Systems engineering","level":1,"score":0.36410582065582275},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.34750187397003174},{"id":"https://openalex.org/C115903868","wikidata":"https://www.wikidata.org/wiki/Q80993","display_name":"Software engineering","level":1,"score":0.3375436067581177},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.3374096751213074},{"id":"https://openalex.org/C19351080","wikidata":"https://www.wikidata.org/wiki/Q1395034","display_name":"New product development","level":2,"score":0.3205288052558899},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.09706541895866394},{"id":"https://openalex.org/C199360897","wikidata":"https://www.wikidata.org/wiki/Q9143","display_name":"Programming language","level":1,"score":0.07515841722488403},{"id":"https://openalex.org/C78458016","wikidata":"https://www.wikidata.org/wiki/Q840400","display_name":"Evolutionary biology","level":1,"score":0.0},{"id":"https://openalex.org/C2524010","wikidata":"https://www.wikidata.org/wiki/Q8087","display_name":"Geometry","level":1,"score":0.0},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.0},{"id":"https://openalex.org/C42525527","wikidata":"https://www.wikidata.org/wiki/Q1209955","display_name":"Formative assessment","level":2,"score":0.0},{"id":"https://openalex.org/C136764020","wikidata":"https://www.wikidata.org/wiki/Q466","display_name":"World Wide Web","level":1,"score":0.0},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.0},{"id":"https://openalex.org/C78519656","wikidata":"https://www.wikidata.org/wiki/Q101333","display_name":"Mechanical engineering","level":1,"score":0.0},{"id":"https://openalex.org/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.0},{"id":"https://openalex.org/C187736073","wikidata":"https://www.wikidata.org/wiki/Q2920921","display_name":"Management","level":1,"score":0.0},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.0},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.0},{"id":"https://openalex.org/C162853370","wikidata":"https://www.wikidata.org/wiki/Q39809","display_name":"Marketing","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.3233/atde210138","is_oa":true,"landing_page_url":"https://doi.org/10.3233/atde210138","pdf_url":"https://ebooks.iospress.nl/pdf/doi/10.3233/ATDE210138","source":{"id":"https://openalex.org/S4210187496","display_name":"Advances in transdisciplinary engineering","issn_l":"2352-751X","issn":["2352-751X","2352-7528"],"is_oa":true,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318577","host_organization_name":"IOS Press","host_organization_lineage":["https://openalex.org/P4310318577"],"host_organization_lineage_names":["IOS Press"],"type":"book series"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Advances in Transdisciplinary Engineering","raw_type":"book-chapter"}],"best_oa_location":{"id":"doi:10.3233/atde210138","is_oa":true,"landing_page_url":"https://doi.org/10.3233/atde210138","pdf_url":"https://ebooks.iospress.nl/pdf/doi/10.3233/ATDE210138","source":{"id":"https://openalex.org/S4210187496","display_name":"Advances in transdisciplinary engineering","issn_l":"2352-751X","issn":["2352-751X","2352-7528"],"is_oa":true,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318577","host_organization_name":"IOS Press","host_organization_lineage":["https://openalex.org/P4310318577"],"host_organization_lineage_names":["IOS Press"],"type":"book series"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Advances in Transdisciplinary Engineering","raw_type":"book-chapter"},"sustainable_development_goals":[{"display_name":"Responsible consumption and production","score":0.49000000953674316,"id":"https://metadata.un.org/sdg/12"}],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W3210144257.pdf","grobid_xml":"https://content.openalex.org/works/W3210144257.grobid-xml"},"referenced_works_count":20,"referenced_works":["https://openalex.org/W349156742","https://openalex.org/W792637354","https://openalex.org/W1914744273","https://openalex.org/W1971350314","https://openalex.org/W1994690836","https://openalex.org/W2004013232","https://openalex.org/W2139203596","https://openalex.org/W2803524339","https://openalex.org/W2807096227","https://openalex.org/W2808207845","https://openalex.org/W2891176716","https://openalex.org/W2894705229","https://openalex.org/W2919398665","https://openalex.org/W2937664243","https://openalex.org/W3010460685","https://openalex.org/W3114832960","https://openalex.org/W4210922514","https://openalex.org/W4242260217","https://openalex.org/W4300948588","https://openalex.org/W6637751807"],"related_works":["https://openalex.org/W2063671807","https://openalex.org/W2113263874","https://openalex.org/W2992240247","https://openalex.org/W2236711079","https://openalex.org/W2044277670","https://openalex.org/W2376204957","https://openalex.org/W2166876396","https://openalex.org/W2028933246","https://openalex.org/W128280668","https://openalex.org/W2080418646"],"abstract_inverted_index":{"In":[0],"the":[1,5,13,16,50,56,61,81,90,119,122,146,166,169,179,193,198],"search":[2],"to":[3,66,88,143,185],"maintain":[4],"integrity":[6],"of":[7,15,161,168,172,197],"all":[8],"systems":[9],"and":[10,25,152],"components":[11],"over":[12],"span":[14],"product\u2019s":[17,62],"life,":[18],"a":[19,29,40,67,107,129,135,173,187,202],"tightly":[20,68],"integrated":[21,105,137],"risk":[22,43,57,109,116,138,147,199],"management":[23,44,110],"process":[24,48,75],"system":[26],"shall":[27],"enable":[28],"discrete":[30],"but":[31],"frequent":[32],"enough":[33],"calculation":[34],"method.":[35],"The":[36,98,126,159],"challenge":[37],"is":[38,45,53,86,149,176],"finding":[39],"methodology":[41,131],"where":[42,201],"living,":[46],"concomitant":[47],"throughout":[49,95],"lifecycle,":[51],"which":[52,175],"cumulative,":[54],"so":[55,84],"assessments":[58],"refine":[59],"with":[60,106,134,178],"definition":[63],"while":[64,118],"adhering":[65],"regulated":[69],"enviroment":[70],"for":[71],"medical":[72],"devices.":[73],"This":[74,183],"needs":[76],"be":[77,141],"fully":[78],"embedded":[79],"in":[80,121],"PLM":[82,136,157],"processes":[83],"it":[85],"able":[87],"accompany":[89],"product":[91,174],"at":[92],"any":[93],"change":[94],"its":[96],"life.":[97],"Multi-interfaces":[99,180],"Entity":[100,181],"Model":[101],"(MIEM)":[102],"was":[103],"introduced":[104],"summative":[108],"concept":[111],"that":[112,132],"allows":[113,184],"an":[114,155],"incremental":[115],"analysis,":[117],"entities":[120],"MIEM":[123],"are":[124],"refined.":[125],"results":[127],"were":[128],"recursive":[130],"supported":[133],"management,":[139],"can":[140],"automated":[142],"make":[144],"sure":[145],"assessment":[148,200],"complete,":[150],"re-usable":[151],"configurable":[153],"as":[154],"additional":[156],"function.":[158],"focus":[160],"this":[162],"paper":[163],"lies":[164],"on":[165],"generation":[167],"functional":[170],"structure":[171],"connected":[177],"Model.":[182],"create":[186,206],"configured":[188],"design":[189],"structure,":[190],"applying":[191],"recursively":[192],"same":[194],"cumulative":[195],"properties":[196],"new":[203,207],"configuration":[204],"would":[205],"interfaces.":[208]},"counts_by_year":[{"year":2022,"cited_by_count":1}],"updated_date":"2026-06-11T09:08:48.828518","created_date":"2025-10-10T00:00:00"}
