{"id":"https://openalex.org/W2997404580","doi":"https://doi.org/10.1145/3366650.3366670","title":"Applying ISO/IEC 29110 to ISO/IEC 62304 for Medical Device Software SME","display_name":"Applying ISO/IEC 29110 to ISO/IEC 62304 for Medical Device Software SME","publication_year":2019,"publication_date":"2019-10-18","ids":{"openalex":"https://openalex.org/W2997404580","doi":"https://doi.org/10.1145/3366650.3366670","mag":"2997404580"},"language":"en","primary_location":{"id":"doi:10.1145/3366650.3366670","is_oa":false,"landing_page_url":"https://doi.org/10.1145/3366650.3366670","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Proceedings of the 2nd International Conference on Computing and Big Data","raw_type":"proceedings-article"},"type":"conference-paper","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/A5020220694","display_name":"Natsuda Kasisopha","orcid":"https://orcid.org/0000-0002-5294-8923"},"institutions":[{"id":"https://openalex.org/I14316845","display_name":"National Electronics and Computer Technology Center","ror":"https://ror.org/04z82ry91","country_code":"TH","type":"government","lineage":["https://openalex.org/I1332092204","https://openalex.org/I14316845"]}],"countries":["TH"],"is_corresponding":false,"raw_author_name":"Natsuda Kasisopha","raw_affiliation_strings":["National Electronics and Computer Technology Center, Khlong Luang, Pathumthani, Thailand"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"National Electronics and Computer Technology Center, Khlong Luang, Pathumthani, Thailand","institution_ids":["https://openalex.org/I14316845"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5053947216","display_name":"Panita Meananeatra","orcid":null},"institutions":[{"id":"https://openalex.org/I14316845","display_name":"National Electronics and Computer Technology Center","ror":"https://ror.org/04z82ry91","country_code":"TH","type":"government","lineage":["https://openalex.org/I1332092204","https://openalex.org/I14316845"]}],"countries":["TH"],"is_corresponding":false,"raw_author_name":"Panita Meananeatra","raw_affiliation_strings":["National Electronics and Computer Technology Center, Khlong Luang, Pathumthani, Thailand"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"National Electronics and Computer Technology Center, Khlong Luang, Pathumthani, Thailand","institution_ids":["https://openalex.org/I14316845"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":["https://openalex.org/I14316845"],"apc_list":null,"apc_paid":null,"fwci":1.1346,"has_fulltext":false,"cited_by_count":5,"citation_normalized_percentile":{"value":0.76974687,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":96},"biblio":{"volume":null,"issue":null,"first_page":"121","last_page":"125"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13295","display_name":"Safety Systems Engineering in Autonomy","score":0.9991000294685364,"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"}},"topics":[{"id":"https://openalex.org/T13295","display_name":"Safety Systems Engineering in Autonomy","score":0.9991000294685364,"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"}},{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.9958999752998352,"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/T13248","display_name":"Healthcare Technology and Patient Monitoring","score":0.97079998254776,"subfield":{"id":"https://openalex.org/subfields/2746","display_name":"Surgery"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/information-security-management-system","display_name":"Information security management system","score":0.7780662178993225},{"id":"https://openalex.org/keywords/medical-software","display_name":"Medical software","score":0.6500215530395508},{"id":"https://openalex.org/keywords/certification","display_name":"Certification","score":0.6310835480690002},{"id":"https://openalex.org/keywords/context","display_name":"Context (archaeology)","score":0.560838520526886},{"id":"https://openalex.org/keywords/quality-management-system","display_name":"Quality management system","score":0.43165555596351624},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.40704357624053955},{"id":"https://openalex.org/keywords/software","display_name":"Software","score":0.34977301955223083},{"id":"https://openalex.org/keywords/software-engineering","display_name":"Software engineering","score":0.3250117599964142},{"id":"https://openalex.org/keywords/software-quality","display_name":"Software quality","score":0.29610753059387207},{"id":"https://openalex.org/keywords/engineering","display_name":"Engineering","score":0.26696300506591797},{"id":"https://openalex.org/keywords/quality-management","display_name":"Quality management","score":0.26133590936660767},{"id":"https://openalex.org/keywords/software-development","display_name":"Software development","score":0.2090727984905243},{"id":"https://openalex.org/keywords/operations-management","display_name":"Operations management","score":0.16076871752738953},{"id":"https://openalex.org/keywords/management-system","display_name":"Management system","score":0.13244009017944336}],"concepts":[{"id":"https://openalex.org/C111153917","wikidata":"https://www.wikidata.org/wiki/Q1662500","display_name":"Information security management system","level":5,"score":0.7780662178993225},{"id":"https://openalex.org/C28143949","wikidata":"https://www.wikidata.org/wiki/Q3751111","display_name":"Medical software","level":5,"score":0.6500215530395508},{"id":"https://openalex.org/C46304622","wikidata":"https://www.wikidata.org/wiki/Q374814","display_name":"Certification","level":2,"score":0.6310835480690002},{"id":"https://openalex.org/C2779343474","wikidata":"https://www.wikidata.org/wiki/Q3109175","display_name":"Context (archaeology)","level":2,"score":0.560838520526886},{"id":"https://openalex.org/C201289532","wikidata":"https://www.wikidata.org/wiki/Q608513","display_name":"Quality management system","level":4,"score":0.43165555596351624},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.40704357624053955},{"id":"https://openalex.org/C2777904410","wikidata":"https://www.wikidata.org/wiki/Q7397","display_name":"Software","level":2,"score":0.34977301955223083},{"id":"https://openalex.org/C115903868","wikidata":"https://www.wikidata.org/wiki/Q80993","display_name":"Software engineering","level":1,"score":0.3250117599964142},{"id":"https://openalex.org/C117447612","wikidata":"https://www.wikidata.org/wiki/Q1412670","display_name":"Software quality","level":4,"score":0.29610753059387207},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.26696300506591797},{"id":"https://openalex.org/C71405471","wikidata":"https://www.wikidata.org/wiki/Q757012","display_name":"Quality management","level":3,"score":0.26133590936660767},{"id":"https://openalex.org/C529173508","wikidata":"https://www.wikidata.org/wiki/Q638608","display_name":"Software development","level":3,"score":0.2090727984905243},{"id":"https://openalex.org/C21547014","wikidata":"https://www.wikidata.org/wiki/Q1423657","display_name":"Operations management","level":1,"score":0.16076871752738953},{"id":"https://openalex.org/C198783460","wikidata":"https://www.wikidata.org/wiki/Q629173","display_name":"Management system","level":2,"score":0.13244009017944336},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.0},{"id":"https://openalex.org/C103377522","wikidata":"https://www.wikidata.org/wiki/Q3493999","display_name":"Security information and event management","level":4,"score":0.0},{"id":"https://openalex.org/C151730666","wikidata":"https://www.wikidata.org/wiki/Q7205","display_name":"Paleontology","level":1,"score":0.0},{"id":"https://openalex.org/C111919701","wikidata":"https://www.wikidata.org/wiki/Q9135","display_name":"Operating system","level":1,"score":0.0},{"id":"https://openalex.org/C79974875","wikidata":"https://www.wikidata.org/wiki/Q483639","display_name":"Cloud computing","level":2,"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/C184842701","wikidata":"https://www.wikidata.org/wiki/Q370563","display_name":"Cloud computing security","level":3,"score":0.0},{"id":"https://openalex.org/C199360897","wikidata":"https://www.wikidata.org/wiki/Q9143","display_name":"Programming language","level":1,"score":0.0},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1145/3366650.3366670","is_oa":false,"landing_page_url":"https://doi.org/10.1145/3366650.3366670","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Proceedings of the 2nd International Conference on Computing and Big Data","raw_type":"proceedings-article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.5299999713897705,"id":"https://metadata.un.org/sdg/12","display_name":"Responsible consumption and production"}],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":10,"referenced_works":["https://openalex.org/W1484259467","https://openalex.org/W1563645046","https://openalex.org/W1983406451","https://openalex.org/W2037889871","https://openalex.org/W2138912677","https://openalex.org/W2169589540","https://openalex.org/W2618046233","https://openalex.org/W2967853175","https://openalex.org/W3022150284","https://openalex.org/W4230446698"],"related_works":["https://openalex.org/W2066052364","https://openalex.org/W2023743128","https://openalex.org/W4243365217","https://openalex.org/W2224296908","https://openalex.org/W3109981693","https://openalex.org/W2381980429","https://openalex.org/W2384206113","https://openalex.org/W645983410","https://openalex.org/W295600311","https://openalex.org/W63787283"],"abstract_inverted_index":{"Medical":[0,4],"Device":[1,5],"(MD)":[2],"and":[3,17,27,39,46,51,98,122,127,135],"Software":[6],"(MDS)":[7],"imperatively":[8],"precise":[9],"as":[10],"they":[11],"are":[12,53,57,145],"dealing":[13],"with":[14],"human":[15,18],"life":[16],"health.":[19],"Nowadays,":[20],"medical":[21],"device":[22],"product":[23],"manufactured":[24],"by":[25],"small":[26,68,91,111],"medium":[28],"companies/entities/organization,":[29],"which":[30],"diverge":[31],"from":[32],"the":[33,37,44,74,79,95,102,110,125,140],"past.":[34],"To":[35],"control":[36],"quality":[38],"security":[40],"of":[41,67,73,130],"those":[42],"products,":[43],"Food":[45],"Drug":[47],"Administration":[48],"(FDA)":[49],"regulation":[50],"IEC60601":[52,56],"compulsory.":[54],"Moreover,":[55],"referring":[58],"to":[59,77,100,108,115],"ISO/IEC":[60,80,96,103,117,131,133,136],"62304":[61,81,104,118],"on":[62,139],"MDS":[63],"development.":[64],"The":[65],"burden":[66],"entities":[69],"is":[70,107],"an":[71],"unawareness":[72],"initiation":[75],"point":[76],"adopting":[78],"processes.":[82,105],"This":[83,106],"paper,":[84],"we":[85],"present":[86],"a":[87,90],"directive":[88],"for":[89],"entity":[92,112],"who":[93],"employed":[94],"29110":[97],"aspire":[99],"apply":[101,116],"prepare":[109],"in":[113],"planning":[114],"before":[119],"further":[120],"testing":[121],"certification.":[123],"Hence,":[124],"reviewed":[126],"aligned":[128],"context":[129],"62304,":[132],"29110,":[134],"12207":[137],"standards":[138],"System":[141],"Life":[142],"Cycle":[143],"processes":[144],"necessary.":[146]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2024,"cited_by_count":2},{"year":2022,"cited_by_count":1},{"year":2021,"cited_by_count":1}],"updated_date":"2026-07-29T14:22:42.915294","created_date":"2025-10-10T00:00:00"}
