{"id":"https://openalex.org/W2106971206","doi":"https://doi.org/10.1109/icse-companion.2009.5070973","title":"Improving software Risk Management in a Medical Device Company","display_name":"Improving software Risk Management in a Medical Device Company","publication_year":2009,"publication_date":"2009-01-01","ids":{"openalex":"https://openalex.org/W2106971206","doi":"https://doi.org/10.1109/icse-companion.2009.5070973","mag":"2106971206"},"language":"en","primary_location":{"id":"doi:10.1109/icse-companion.2009.5070973","is_oa":false,"landing_page_url":"https://doi.org/10.1109/icse-companion.2009.5070973","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"2009 31st International Conference on Software Engineering - Companion Volume","raw_type":"proceedings-article"},"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5027366406","display_name":"Fergal McCaffery","orcid":"https://orcid.org/0000-0002-0839-8362"},"institutions":[{"id":"https://openalex.org/I94876832","display_name":"Dundalk Institute of Technology","ror":"https://ror.org/01800zd49","country_code":"IE","type":"education","lineage":["https://openalex.org/I94876832"]}],"countries":["IE"],"is_corresponding":true,"raw_author_name":"Fergal McCaffery","raw_affiliation_strings":["Dundalk Institute of Technology, Ireland"],"affiliations":[{"raw_affiliation_string":"Dundalk Institute of Technology, Ireland","institution_ids":["https://openalex.org/I94876832"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5016097602","display_name":"John Burton","orcid":null},"institutions":[{"id":"https://openalex.org/I4210098116","display_name":"Vitalograph (Ireland)","ror":"https://ror.org/00xgwej35","country_code":"IE","type":"company","lineage":["https://openalex.org/I4210098116"]}],"countries":["IE"],"is_corresponding":false,"raw_author_name":"John Burton","raw_affiliation_strings":["Vitalograph Limited, Ireland","Vitalograph Ltd., Ireland"],"affiliations":[{"raw_affiliation_string":"Vitalograph Limited, Ireland","institution_ids":[]},{"raw_affiliation_string":"Vitalograph Ltd., Ireland","institution_ids":["https://openalex.org/I4210098116"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5008455344","display_name":"Ita Richardson","orcid":"https://orcid.org/0000-0002-5493-2837"},"institutions":[{"id":"https://openalex.org/I230495080","display_name":"University of Limerick","ror":"https://ror.org/00a0n9e72","country_code":"IE","type":"education","lineage":["https://openalex.org/I230495080"]},{"id":"https://openalex.org/I4210130076","display_name":"Lero","ror":"https://ror.org/038dhnb42","country_code":"IE","type":"other","lineage":["https://openalex.org/I4210130076"]}],"countries":["IE"],"is_corresponding":false,"raw_author_name":"Ita Richardson","raw_affiliation_strings":["Lero-the Irish Software Engineering Research Centre, University of Limerick, Ireland","Lero, The Irish Software Engineering Research Centre, University of Limerick, Ireland"],"affiliations":[{"raw_affiliation_string":"Lero-the Irish Software Engineering Research Centre, University of Limerick, Ireland","institution_ids":["https://openalex.org/I4210130076","https://openalex.org/I230495080"]},{"raw_affiliation_string":"Lero, The Irish Software Engineering Research Centre, University of Limerick, Ireland","institution_ids":["https://openalex.org/I4210130076","https://openalex.org/I230495080"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5027366406"],"corresponding_institution_ids":["https://openalex.org/I94876832"],"apc_list":null,"apc_paid":null,"fwci":3.8815,"has_fulltext":false,"cited_by_count":12,"citation_normalized_percentile":{"value":0.94485839,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":89,"max":97},"biblio":{"volume":"40","issue":null,"first_page":"152","last_page":"162"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10430","display_name":"Software Engineering Techniques and Practices","score":0.9969000220298767,"subfield":{"id":"https://openalex.org/subfields/1710","display_name":"Information Systems"},"field":{"id":"https://openalex.org/fields/17","display_name":"Computer Science"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T10430","display_name":"Software Engineering Techniques and Practices","score":0.9969000220298767,"subfield":{"id":"https://openalex.org/subfields/1710","display_name":"Information Systems"},"field":{"id":"https://openalex.org/fields/17","display_name":"Computer Science"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.9955000281333923,"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/T13295","display_name":"Safety Systems Engineering in Autonomy","score":0.978600025177002,"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/capability-maturity-model-integration","display_name":"Capability Maturity Model Integration","score":0.8470509052276611},{"id":"https://openalex.org/keywords/capability-maturity-model","display_name":"Capability Maturity Model","score":0.6593856811523438},{"id":"https://openalex.org/keywords/software-development-process","display_name":"Software development process","score":0.5489948987960815},{"id":"https://openalex.org/keywords/risk-management","display_name":"Risk management","score":0.5434269905090332},{"id":"https://openalex.org/keywords/medical-software","display_name":"Medical software","score":0.5243285298347473},{"id":"https://openalex.org/keywords/application-lifecycle-management","display_name":"Application lifecycle management","score":0.5223692059516907},{"id":"https://openalex.org/keywords/software-development","display_name":"Software development","score":0.4685792624950409},{"id":"https://openalex.org/keywords/software-project-management","display_name":"Software project management","score":0.46620476245880127},{"id":"https://openalex.org/keywords/maturity","display_name":"Maturity (psychological)","score":0.44378378987312317},{"id":"https://openalex.org/keywords/leancmmi","display_name":"LeanCMMI","score":0.4391137659549713},{"id":"https://openalex.org/keywords/software","display_name":"Software","score":0.4343757629394531},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.4105723202228546},{"id":"https://openalex.org/keywords/software-engineering","display_name":"Software engineering","score":0.3976982831954956},{"id":"https://openalex.org/keywords/risk-analysis","display_name":"Risk analysis (engineering)","score":0.39737945795059204},{"id":"https://openalex.org/keywords/engineering","display_name":"Engineering","score":0.3845829963684082},{"id":"https://openalex.org/keywords/process-management","display_name":"Process management","score":0.3818802833557129},{"id":"https://openalex.org/keywords/engineering-management","display_name":"Engineering management","score":0.3796476721763611},{"id":"https://openalex.org/keywords/software-quality","display_name":"Software quality","score":0.23922055959701538},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.20918366312980652},{"id":"https://openalex.org/keywords/software-construction","display_name":"Software construction","score":0.1841246783733368},{"id":"https://openalex.org/keywords/operating-system","display_name":"Operating system","score":0.07878154516220093}],"concepts":[{"id":"https://openalex.org/C182406803","wikidata":"https://www.wikidata.org/wiki/Q428361","display_name":"Capability Maturity Model Integration","level":5,"score":0.8470509052276611},{"id":"https://openalex.org/C85890633","wikidata":"https://www.wikidata.org/wiki/Q929673","display_name":"Capability Maturity Model","level":3,"score":0.6593856811523438},{"id":"https://openalex.org/C180152950","wikidata":"https://www.wikidata.org/wiki/Q2904257","display_name":"Software development process","level":4,"score":0.5489948987960815},{"id":"https://openalex.org/C32896092","wikidata":"https://www.wikidata.org/wiki/Q189447","display_name":"Risk management","level":2,"score":0.5434269905090332},{"id":"https://openalex.org/C28143949","wikidata":"https://www.wikidata.org/wiki/Q3751111","display_name":"Medical software","level":5,"score":0.5243285298347473},{"id":"https://openalex.org/C30452754","wikidata":"https://www.wikidata.org/wiki/Q621590","display_name":"Application lifecycle management","level":3,"score":0.5223692059516907},{"id":"https://openalex.org/C529173508","wikidata":"https://www.wikidata.org/wiki/Q638608","display_name":"Software development","level":3,"score":0.4685792624950409},{"id":"https://openalex.org/C40919944","wikidata":"https://www.wikidata.org/wiki/Q947779","display_name":"Software project management","level":5,"score":0.46620476245880127},{"id":"https://openalex.org/C101433766","wikidata":"https://www.wikidata.org/wiki/Q3543263","display_name":"Maturity (psychological)","level":2,"score":0.44378378987312317},{"id":"https://openalex.org/C68269808","wikidata":"https://www.wikidata.org/wiki/Q17096559","display_name":"LeanCMMI","level":5,"score":0.4391137659549713},{"id":"https://openalex.org/C2777904410","wikidata":"https://www.wikidata.org/wiki/Q7397","display_name":"Software","level":2,"score":0.4343757629394531},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.4105723202228546},{"id":"https://openalex.org/C115903868","wikidata":"https://www.wikidata.org/wiki/Q80993","display_name":"Software engineering","level":1,"score":0.3976982831954956},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.39737945795059204},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.3845829963684082},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.3818802833557129},{"id":"https://openalex.org/C110354214","wikidata":"https://www.wikidata.org/wiki/Q6314146","display_name":"Engineering management","level":1,"score":0.3796476721763611},{"id":"https://openalex.org/C117447612","wikidata":"https://www.wikidata.org/wiki/Q1412670","display_name":"Software quality","level":4,"score":0.23922055959701538},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.20918366312980652},{"id":"https://openalex.org/C186846655","wikidata":"https://www.wikidata.org/wiki/Q3398377","display_name":"Software construction","level":4,"score":0.1841246783733368},{"id":"https://openalex.org/C111919701","wikidata":"https://www.wikidata.org/wiki/Q9135","display_name":"Operating system","level":1,"score":0.07878154516220093},{"id":"https://openalex.org/C138496976","wikidata":"https://www.wikidata.org/wiki/Q175002","display_name":"Developmental psychology","level":1,"score":0.0},{"id":"https://openalex.org/C15744967","wikidata":"https://www.wikidata.org/wiki/Q9418","display_name":"Psychology","level":0,"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":3,"locations":[{"id":"doi:10.1109/icse-companion.2009.5070973","is_oa":false,"landing_page_url":"https://doi.org/10.1109/icse-companion.2009.5070973","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"2009 31st International Conference on Software Engineering - Companion Volume","raw_type":"proceedings-article"},{"id":"pmh:oai:eprints.dkit.ie:127","is_oa":false,"landing_page_url":"http://eprints.dkit.ie/127/1/Improving_Software_Risk_Management_in_a_Medical_Device_Company.docx","pdf_url":null,"source":{"id":"https://openalex.org/S4377196592","display_name":"STOR (Dundalk Institute of Technology)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I94876832","host_organization_name":"Dundalk Institute of Technology","host_organization_lineage":["https://openalex.org/I94876832"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":"","raw_type":"Conference or Workshop Item"},{"id":"pmh:oai:ulir.ul.ie:10344/2294","is_oa":false,"landing_page_url":"http://hdl.handle.net/10344/2294","pdf_url":null,"source":{"id":"https://openalex.org/S4306401530","display_name":"University of Limerick Institutional Repository (University of Limerick)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I230495080","host_organization_name":"University of Limerick","host_organization_lineage":["https://openalex.org/I230495080"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":"","raw_type":"info:eu-repo/semantics/conferenceObject"}],"best_oa_location":null,"sustainable_development_goals":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":12,"referenced_works":["https://openalex.org/W1765266268","https://openalex.org/W1991650436","https://openalex.org/W2036498929","https://openalex.org/W2047805825","https://openalex.org/W2055062090","https://openalex.org/W2108220717","https://openalex.org/W2166858912","https://openalex.org/W2324093677","https://openalex.org/W2464594789","https://openalex.org/W2877591110","https://openalex.org/W4320009379","https://openalex.org/W6719302853"],"related_works":["https://openalex.org/W3087519164","https://openalex.org/W1687973363","https://openalex.org/W2020425823","https://openalex.org/W2198962457","https://openalex.org/W3162340503","https://openalex.org/W1564266144","https://openalex.org/W2939019733","https://openalex.org/W2051063356","https://openalex.org/W2387410173","https://openalex.org/W2108220717"],"abstract_inverted_index":{"Software":[0],"Risk":[1,116],"Management":[2,117],"(RM)":[3],"within":[4],"Medical":[5],"Device":[6],"(MD)":[7],"companies":[8],"is":[9,112],"a":[10,59,68,86],"critical":[11],"area.":[12],"Failure":[13],"of":[14,25,44,58,85,103,132],"the":[15,42,50,56,83,99,104,115,124,130,133],"software":[16,51,61,87],"can":[17],"have":[18],"potentially":[19],"catastrophic":[20],"effects,":[21],"leading":[22],"to":[23,41,71],"injury":[24],"patients":[26],"or":[27],"even":[28],"death.":[29],"Therefore":[30],"regulators":[31],"penalise":[32],"MD":[33,60,95],"manufacturers":[34],"that":[35,92],"do":[36],"not":[37],"devote":[38],"sufficient":[39],"attention":[40],"areas":[43],"hazard":[45],"analysis":[46],"and":[47,101,128],"RM":[48,74,90,96],"throughout":[49],"lifecycle.":[52],"This":[53,110],"paper":[54],"describes":[55],"experience":[57],"development":[62,84],"organization":[63],"when":[64],"they":[65],"engaged":[66],"in":[67],"research":[69],"project":[70,126],"improve":[72],"their":[73],"practices.":[75],"We":[76],"explain":[77],"how":[78],"this":[79],"was":[80],"achieved":[81],"through":[82],"process":[88],"improvement":[89],"model":[91,111],"integrates":[93],"regulatory":[94],"requirements":[97],"with":[98],"goals":[100],"practices":[102],"Capability":[105,118],"Maturity":[106],"Model":[107,119],"Integration":[108],"(CMMI).":[109],"known":[113],"as":[114],"(RMCM).":[120],"The":[121],"authors":[122],"describe":[123],"complete":[125],"lifecycle":[127],"evaluate":[129],"success":[131],"project.":[134]},"counts_by_year":[{"year":2020,"cited_by_count":1},{"year":2018,"cited_by_count":1},{"year":2016,"cited_by_count":1},{"year":2015,"cited_by_count":3},{"year":2013,"cited_by_count":1},{"year":2012,"cited_by_count":1}],"updated_date":"2026-04-05T17:49:38.594831","created_date":"2025-10-10T00:00:00"}
