{"id":"https://openalex.org/W4411996261","doi":"https://doi.org/10.1109/smartcomp65954.2025.00079","title":"Cybersecurity Guidances for Medical Devices: An MDCG and FDA Regulatory Comparison","display_name":"Cybersecurity Guidances for Medical Devices: An MDCG and FDA Regulatory Comparison","publication_year":2025,"publication_date":"2025-06-16","ids":{"openalex":"https://openalex.org/W4411996261","doi":"https://doi.org/10.1109/smartcomp65954.2025.00079"},"language":"en","primary_location":{"id":"doi:10.1109/smartcomp65954.2025.00079","is_oa":false,"landing_page_url":"https://doi.org/10.1109/smartcomp65954.2025.00079","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"2025 IEEE International Conference on Smart Computing (SMARTCOMP)","raw_type":"proceedings-article"},"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://doi.org/10.1109/SMARTCOMP65954.2025.00079","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5068547034","display_name":"Andrea Neverdal Skytterholm","orcid":null},"institutions":[{"id":"https://openalex.org/I4387930215","display_name":"SINTEF Digital","ror":"https://ror.org/028m52w57","country_code":null,"type":"facility","lineage":["https://openalex.org/I173888879","https://openalex.org/I4387930215"]},{"id":"https://openalex.org/I173888879","display_name":"SINTEF","ror":"https://ror.org/01f677e56","country_code":"NO","type":"facility","lineage":["https://openalex.org/I173888879"]}],"countries":["NO"],"is_corresponding":true,"raw_author_name":"Andrea Neverdal Skytterholm","raw_affiliation_strings":["Software Engineering, Safety and Security, SINTEF Digital,Trondheim,Norway"],"affiliations":[{"raw_affiliation_string":"Software Engineering, Safety and Security, SINTEF Digital,Trondheim,Norway","institution_ids":["https://openalex.org/I173888879","https://openalex.org/I4387930215"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5067659400","display_name":"Christos Androutsos","orcid":null},"institutions":[{"id":"https://openalex.org/I194019607","display_name":"University of Ioannina","ror":"https://ror.org/01qg3j183","country_code":"GR","type":"education","lineage":["https://openalex.org/I194019607"]}],"countries":["GR"],"is_corresponding":false,"raw_author_name":"Christos Androutsos","raw_affiliation_strings":["University of Ioannina,Ioannina,Greece"],"affiliations":[{"raw_affiliation_string":"University of Ioannina,Ioannina,Greece","institution_ids":["https://openalex.org/I194019607"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5059932929","display_name":"Adamantios Ntanis","orcid":"https://orcid.org/0000-0002-1161-4222"},"institutions":[{"id":"https://openalex.org/I194019607","display_name":"University of Ioannina","ror":"https://ror.org/01qg3j183","country_code":"GR","type":"education","lineage":["https://openalex.org/I194019607"]}],"countries":["GR"],"is_corresponding":false,"raw_author_name":"Adamantios Ntanis","raw_affiliation_strings":["PD Neurotechnology Ltd.,R&D Department,Ioannina,Greece"],"affiliations":[{"raw_affiliation_string":"PD Neurotechnology Ltd.,R&D Department,Ioannina,Greece","institution_ids":["https://openalex.org/I194019607"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5071836226","display_name":"Martin Gilje Jaatun","orcid":"https://orcid.org/0000-0001-7127-6694"},"institutions":[{"id":"https://openalex.org/I173888879","display_name":"SINTEF","ror":"https://ror.org/01f677e56","country_code":"NO","type":"facility","lineage":["https://openalex.org/I173888879"]},{"id":"https://openalex.org/I4387930215","display_name":"SINTEF Digital","ror":"https://ror.org/028m52w57","country_code":null,"type":"facility","lineage":["https://openalex.org/I173888879","https://openalex.org/I4387930215"]}],"countries":["NO"],"is_corresponding":false,"raw_author_name":"Martin Gilje Jaatun","raw_affiliation_strings":["Software Engineering, Safety and Security, SINTEF Digital,Trondheim,Norway"],"affiliations":[{"raw_affiliation_string":"Software Engineering, Safety and Security, SINTEF Digital,Trondheim,Norway","institution_ids":["https://openalex.org/I173888879","https://openalex.org/I4387930215"]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":4,"corresponding_author_ids":["https://openalex.org/A5068547034"],"corresponding_institution_ids":["https://openalex.org/I173888879","https://openalex.org/I4387930215"],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.23238016,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":"336","last_page":"341"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13295","display_name":"Safety Systems Engineering in Autonomy","score":0.9279999732971191,"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":0.9279999732971191,"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/computer-security","display_name":"Computer security","score":0.508482813835144},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.46779757738113403},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.40530988574028015}],"concepts":[{"id":"https://openalex.org/C38652104","wikidata":"https://www.wikidata.org/wiki/Q3510521","display_name":"Computer security","level":1,"score":0.508482813835144},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.46779757738113403},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.40530988574028015}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.1109/smartcomp65954.2025.00079","is_oa":false,"landing_page_url":"https://doi.org/10.1109/smartcomp65954.2025.00079","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"2025 IEEE International Conference on Smart Computing (SMARTCOMP)","raw_type":"proceedings-article"},{"id":"pmh:oai:zenodo.org:17192028","is_oa":true,"landing_page_url":"https://doi.org/10.1109/SMARTCOMP65954.2025.00079","pdf_url":null,"source":{"id":"https://openalex.org/S4306400562","display_name":"Zenodo (CERN European Organization for Nuclear Research)","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I67311998","host_organization_name":"European Organization for Nuclear Research","host_organization_lineage":["https://openalex.org/I67311998"],"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":"info:eu-repo/semantics/conferencePaper"}],"best_oa_location":{"id":"pmh:oai:zenodo.org:17192028","is_oa":true,"landing_page_url":"https://doi.org/10.1109/SMARTCOMP65954.2025.00079","pdf_url":null,"source":{"id":"https://openalex.org/S4306400562","display_name":"Zenodo (CERN European Organization for Nuclear Research)","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I67311998","host_organization_name":"European Organization for Nuclear Research","host_organization_lineage":["https://openalex.org/I67311998"],"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":"info:eu-repo/semantics/conferencePaper"},"sustainable_development_goals":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":6,"referenced_works":["https://openalex.org/W813923634","https://openalex.org/W2398670377","https://openalex.org/W4221112904","https://openalex.org/W4382456710","https://openalex.org/W4394819435","https://openalex.org/W4400037588"],"related_works":["https://openalex.org/W4391375266","https://openalex.org/W2899084033","https://openalex.org/W2748952813","https://openalex.org/W2390279801","https://openalex.org/W4391913857","https://openalex.org/W2358668433","https://openalex.org/W4396701345","https://openalex.org/W2376932109","https://openalex.org/W2001405890","https://openalex.org/W4396696052"],"abstract_inverted_index":{"This":[0],"paper":[1,110],"compares":[2],"the":[3,14,17,22,27,37,41,66,82,96,109,112,116,140],"distinct":[4],"cybersecurity":[5],"requirements":[6],"for":[7,115],"certifying":[8],"connected":[9],"medical":[10,135],"devices":[11],"(CMDs)":[12],"in":[13,21,129],"EU":[15,84],"and":[16,26,30,43,45,55,91,98,124],"US,":[18],"as":[19],"outlined":[20],"MDCG":[23,42],"2019\u201316":[24],"guidance":[25,48],"FDA":[28,44],"premarket":[29],"postmarket":[31],"guidances,":[32],"respectively.":[33],"By":[34],"examining":[35],"both":[36],"organizational":[38],"approaches":[39],"of":[40,57,100,143],"their":[46],"specific":[47],"documents,":[49],"this":[50],"study":[51],"identifies":[52],"key":[53],"differences":[54],"areas":[56],"convergence.":[58],"Findings,":[59],"informed":[60],"by":[61],"stakeholder":[62],"feedback":[63],"gathered":[64],"within":[65],"Horizon":[67],"Europe":[68],"NEMECYS":[69],"project,":[70],"reveal":[71],"a":[72,104],"notable":[73],"disparity,":[74],"with":[75,81],"CMD":[76],"stakeholders":[77],"expressing":[78],"significant":[79],"dissatisfaction":[80],"current":[83],"regulatory":[85,118],"framework,":[86],"particularly":[87],"regarding":[88],"its":[89],"applicability":[90],"clarity.":[92],"The":[93],"analysis":[94],"highlights":[95],"strengths":[97],"weaknesses":[99],"each":[101],"approach":[102],"from":[103],"practical":[105],"implementation":[106],"perspective.":[107],"Ultimately,":[108],"emphasizes":[111],"critical":[113],"need":[114],"European":[117],"landscape":[119],"to":[120,137],"evolve":[121],"towards":[122],"clearer":[123],"more":[125],"actionable":[126],"guidance,":[127],"especially":[128],"rapidly":[130],"emerging":[131],"fields":[132],"like":[133],"AI-driven":[134],"devices,":[136],"effectively":[138],"support":[139],"secure":[141],"advancement":[142],"CMDs.":[144]},"counts_by_year":[],"updated_date":"2025-11-06T03:46:38.306776","created_date":"2025-10-10T00:00:00"}