{"id":"https://openalex.org/W4306407947","doi":"https://doi.org/10.1007/s11219-022-09601-5","title":"Continuous design control for machine learning in certified medical systems","display_name":"Continuous design control for machine learning in certified medical systems","publication_year":2022,"publication_date":"2022-10-17","ids":{"openalex":"https://openalex.org/W4306407947","doi":"https://doi.org/10.1007/s11219-022-09601-5"},"language":"en","primary_location":{"id":"doi:10.1007/s11219-022-09601-5","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s11219-022-09601-5","pdf_url":"https://link.springer.com/content/pdf/10.1007/s11219-022-09601-5.pdf","source":{"id":"https://openalex.org/S7504070","display_name":"Software Quality Journal","issn_l":"0963-9314","issn":["0963-9314","1573-1367"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Software Quality Journal","raw_type":"journal-article"},"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://link.springer.com/content/pdf/10.1007/s11219-022-09601-5.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5018911783","display_name":"Vlad Stirbu","orcid":"https://orcid.org/0000-0001-9462-5922"},"institutions":[{"id":"https://openalex.org/I133731052","display_name":"University of Helsinki","ror":"https://ror.org/040af2s02","country_code":"FI","type":"education","lineage":["https://openalex.org/I133731052"]}],"countries":["FI"],"is_corresponding":true,"raw_author_name":"Vlad Stirbu","raw_affiliation_strings":["CompliancePal, Tampere, Finland","University of Helsinki, Helsinki, Finland"],"affiliations":[{"raw_affiliation_string":"CompliancePal, Tampere, Finland","institution_ids":[]},{"raw_affiliation_string":"University of Helsinki, Helsinki, Finland","institution_ids":["https://openalex.org/I133731052"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5073064486","display_name":"Tuomas Granlund","orcid":"https://orcid.org/0000-0003-3955-0926"},"institutions":[{"id":"https://openalex.org/I166825849","display_name":"Tampere University","ror":"https://ror.org/033003e23","country_code":"FI","type":"education","lineage":["https://openalex.org/I166825849"]}],"countries":["FI"],"is_corresponding":false,"raw_author_name":"Tuomas Granlund","raw_affiliation_strings":["Solita, Tampere, Finland","Tampere University, Tampere, Finland"],"affiliations":[{"raw_affiliation_string":"Solita, Tampere, Finland","institution_ids":[]},{"raw_affiliation_string":"Tampere University, Tampere, Finland","institution_ids":["https://openalex.org/I166825849"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5074223722","display_name":"Tommi Mikkonen","orcid":"https://orcid.org/0000-0002-8540-9918"},"institutions":[{"id":"https://openalex.org/I133731052","display_name":"University of Helsinki","ror":"https://ror.org/040af2s02","country_code":"FI","type":"education","lineage":["https://openalex.org/I133731052"]},{"id":"https://openalex.org/I94722563","display_name":"University of Jyv\u00e4skyl\u00e4","ror":"https://ror.org/05n3dz165","country_code":"FI","type":"education","lineage":["https://openalex.org/I94722563"]}],"countries":["FI"],"is_corresponding":false,"raw_author_name":"Tommi Mikkonen","raw_affiliation_strings":["University of Helsinki, Helsinki, Finland","University of Jyv\u00e4skyl\u00e4, Jyv\u00e4skyl\u00e4, Finland"],"affiliations":[{"raw_affiliation_string":"University of Helsinki, Helsinki, Finland","institution_ids":["https://openalex.org/I133731052"]},{"raw_affiliation_string":"University of Jyv\u00e4skyl\u00e4, Jyv\u00e4skyl\u00e4, Finland","institution_ids":["https://openalex.org/I94722563"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5018911783"],"corresponding_institution_ids":["https://openalex.org/I133731052"],"apc_list":{"value":2390,"currency":"EUR","value_usd":2990},"apc_paid":{"value":2390,"currency":"EUR","value_usd":2990},"fwci":5.0223,"has_fulltext":true,"cited_by_count":23,"citation_normalized_percentile":{"value":0.95625928,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":96,"max":99},"biblio":{"volume":"31","issue":"2","first_page":"307","last_page":"333"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10883","display_name":"Ethics and Social Impacts of AI","score":0.9811000227928162,"subfield":{"id":"https://openalex.org/subfields/3311","display_name":"Safety Research"},"field":{"id":"https://openalex.org/fields/33","display_name":"Social Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T10883","display_name":"Ethics and Social Impacts of AI","score":0.9811000227928162,"subfield":{"id":"https://openalex.org/subfields/3311","display_name":"Safety Research"},"field":{"id":"https://openalex.org/fields/33","display_name":"Social Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T12026","display_name":"Explainable Artificial Intelligence (XAI)","score":0.9706000089645386,"subfield":{"id":"https://openalex.org/subfields/1702","display_name":"Artificial Intelligence"},"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/T13248","display_name":"Healthcare Technology and Patient Monitoring","score":0.9664000272750854,"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/devops","display_name":"DevOps","score":0.9135733246803284},{"id":"https://openalex.org/keywords/certification","display_name":"Certification","score":0.6934814453125},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.6243067383766174},{"id":"https://openalex.org/keywords/control","display_name":"Control (management)","score":0.489082396030426},{"id":"https://openalex.org/keywords/audit","display_name":"Audit","score":0.42518725991249084},{"id":"https://openalex.org/keywords/software-engineering","display_name":"Software engineering","score":0.4163805842399597},{"id":"https://openalex.org/keywords/artificial-intelligence","display_name":"Artificial intelligence","score":0.3739722967147827},{"id":"https://openalex.org/keywords/software-deployment","display_name":"Software deployment","score":0.09637236595153809}],"concepts":[{"id":"https://openalex.org/C9903902","wikidata":"https://www.wikidata.org/wiki/Q3025536","display_name":"DevOps","level":3,"score":0.9135733246803284},{"id":"https://openalex.org/C46304622","wikidata":"https://www.wikidata.org/wiki/Q374814","display_name":"Certification","level":2,"score":0.6934814453125},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.6243067383766174},{"id":"https://openalex.org/C2775924081","wikidata":"https://www.wikidata.org/wiki/Q55608371","display_name":"Control (management)","level":2,"score":0.489082396030426},{"id":"https://openalex.org/C199521495","wikidata":"https://www.wikidata.org/wiki/Q181487","display_name":"Audit","level":2,"score":0.42518725991249084},{"id":"https://openalex.org/C115903868","wikidata":"https://www.wikidata.org/wiki/Q80993","display_name":"Software engineering","level":1,"score":0.4163805842399597},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.3739722967147827},{"id":"https://openalex.org/C105339364","wikidata":"https://www.wikidata.org/wiki/Q2297740","display_name":"Software deployment","level":2,"score":0.09637236595153809},{"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/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.0},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.0},{"id":"https://openalex.org/C187736073","wikidata":"https://www.wikidata.org/wiki/Q2920921","display_name":"Management","level":1,"score":0.0}],"mesh":[],"locations_count":3,"locations":[{"id":"doi:10.1007/s11219-022-09601-5","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s11219-022-09601-5","pdf_url":"https://link.springer.com/content/pdf/10.1007/s11219-022-09601-5.pdf","source":{"id":"https://openalex.org/S7504070","display_name":"Software Quality Journal","issn_l":"0963-9314","issn":["0963-9314","1573-1367"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Software Quality Journal","raw_type":"journal-article"},{"id":"pmh:oai:jyx.jyu.fi:123456789/83593","is_oa":true,"landing_page_url":"http://urn.fi/URN:NBN:fi:jyu-202210184913","pdf_url":null,"source":{"id":"https://openalex.org/S4306400563","display_name":"Jyv\u00e4skyl\u00e4 University Digital Archive (University of Jyv\u00e4skyl\u00e4)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I94722563","host_organization_name":"University of Jyv\u00e4skyl\u00e4","host_organization_lineage":["https://openalex.org/I94722563"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":null,"raw_type":"A1"},{"id":"pmh:oai:trepo.tuni.fi:10024/223550","is_oa":true,"landing_page_url":"https://trepo.tuni.fi/handle/10024/223550","pdf_url":null,"source":{"id":"https://openalex.org/S7407055260","display_name":"Trepo - Institutional Repository of Tampere University","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article"}],"best_oa_location":{"id":"doi:10.1007/s11219-022-09601-5","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s11219-022-09601-5","pdf_url":"https://link.springer.com/content/pdf/10.1007/s11219-022-09601-5.pdf","source":{"id":"https://openalex.org/S7504070","display_name":"Software Quality Journal","issn_l":"0963-9314","issn":["0963-9314","1573-1367"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Software Quality Journal","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.5799999833106995,"id":"https://metadata.un.org/sdg/9","display_name":"Industry, innovation and infrastructure"}],"awards":[],"funders":[{"id":"https://openalex.org/F4320310086","display_name":"Helsingin Yliopisto","ror":"https://ror.org/040af2s02"},{"id":"https://openalex.org/F4320310467","display_name":"Helsingin ja Uudenmaan Sairaanhoitopiiri","ror":"https://ror.org/020cpqb94"},{"id":"https://openalex.org/F4320328501","display_name":"Business Finland","ror":"https://ror.org/05bgf9v38"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4306407947.pdf","grobid_xml":"https://content.openalex.org/works/W4306407947.grobid-xml"},"referenced_works_count":22,"referenced_works":["https://openalex.org/W806202468","https://openalex.org/W2103668392","https://openalex.org/W2114264681","https://openalex.org/W2189162242","https://openalex.org/W2267596186","https://openalex.org/W2524952001","https://openalex.org/W2743948853","https://openalex.org/W2753691335","https://openalex.org/W2798594949","https://openalex.org/W2897042519","https://openalex.org/W2901626606","https://openalex.org/W3100279624","https://openalex.org/W3110092091","https://openalex.org/W3138819813","https://openalex.org/W3173148850","https://openalex.org/W3180651186","https://openalex.org/W3205025417","https://openalex.org/W3210418146","https://openalex.org/W3214886154","https://openalex.org/W4200225147","https://openalex.org/W4244757210","https://openalex.org/W6628099066"],"related_works":["https://openalex.org/W3154253302","https://openalex.org/W4220665054","https://openalex.org/W4287554096","https://openalex.org/W3111012486","https://openalex.org/W2588979697","https://openalex.org/W2471667150","https://openalex.org/W2911278647","https://openalex.org/W3108642418","https://openalex.org/W2621143560","https://openalex.org/W4225698753"],"abstract_inverted_index":{"Abstract":[0],"Continuous":[1],"software":[2],"engineering":[3],"has":[4],"become":[5],"commonplace":[6],"in":[7,11,58,102],"numerous":[8],"fields.":[9],"However,":[10],"regulating":[12],"intensive":[13],"sectors,":[14],"where":[15],"additional":[16],"concerns":[17],"need":[18],"to":[19,29,55,69,72,94],"be":[20,100],"taken":[21],"into":[22],"account,":[23],"it":[24],"is":[25,83],"often":[26],"considered":[27],"difficult":[28],"apply":[30,52],"continuous":[31,104],"development":[32],"approaches,":[33],"such":[34],"as":[35,48,76],"devops.":[36],"In":[37],"this":[38,53],"paper,":[39],"we":[40,90],"present":[41],"an":[42,86],"approach":[43,54,82],"for":[44],"using":[45],"pull":[46],"requests":[47],"design":[49],"controls,":[50],"and":[51],"machine":[56,73],"learning":[57,74],"certified":[59],"medical":[60,97],"systems":[61,98],"leveraging":[62],"model":[63],"cards,":[64],"a":[65,77,103],"novel":[66],"technique":[67],"developed":[68,101],"add":[70],"explainability":[71],"systems,":[75],"regulatory":[78],"audit":[79],"trail.":[80],"The":[81],"demonstrated":[84],"with":[85],"industrial":[87],"system":[88],"that":[89],"have":[91],"used":[92],"previously":[93],"show":[95],"how":[96],"can":[99],"fashion.":[105]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":11},{"year":2024,"cited_by_count":6},{"year":2023,"cited_by_count":5}],"updated_date":"2026-04-11T08:14:18.477133","created_date":"2025-10-10T00:00:00"}
