{"id":101616,"date":"2024-12-24T08:42:33","date_gmt":"2024-12-24T08:42:33","guid":{"rendered":"https:\/\/www.globallogic.com\/sk\/?post_type=industries&p=101616"},"modified":"2025-03-17T07:59:56","modified_gmt":"2025-03-17T07:59:56","slug":"software-as-a-medical-device-samd","status":"publish","type":"industries","link":"https:\/\/www.globallogic.com\/sk\/industries\/healthcare-and-life-sciences\/software-as-a-medical-device-samd\/","title":{"rendered":"Softv\u00e9r ako zdravotn\u00edcky prostriedok (SaMD)"},"content":{"rendered":"\n
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SaMD rie\u0161enia menia zdravotn\u00edctvo k\u00a0lep\u0161iemu<\/h2>\n\n\n\n
<\/div>\n\n\n\n

Softv\u00e9r ako zdravotn\u00edcky prostriedok (Software as a medical device, SaMD) men\u00ed oblas\u0165 zdravotnej starostlivosti t\u00fdm, \u017ee prin\u00e1\u0161a inteligentnej\u0161ie a\u00a0prepojenej\u0161ie rie\u0161enia pre diagnostiku, lie\u010dbu a\u00a0monitorovanie pacientov. Spolo\u010dnos\u0165 GlobalLogic sp\u00e1ja pri navrhovan\u00ed a\u00a0v\u00fdvoji kompatibiln\u00fdch, bezpe\u010dn\u00fdch a\u00a0intuit\u00edvnych SaMD aplik\u00e1ci\u00ed sily s\u00a0popredn\u00fdmi inov\u00e1tormi v\u00a0oblasti zdravotn\u00edckych technol\u00f3gi\u00ed a\u00a0zdravotnej starostlivosti. V\u010faka na\u0161im odborn\u00fdm znalostiam o\u00a0mobiln\u00fdch platform\u00e1ch, konektivite zariaden\u00ed a\u00a0regula\u010dn\u00fdch po\u017eiadavk\u00e1ch pom\u00e1hame klientom zlep\u0161i\u0165 v\u00fdsledky lie\u010dby pacientov, zefekt\u00edvni\u0165 prev\u00e1dzku a\u00a0zni\u017eova\u0165 n\u00e1klady. Spolo\u010dne formujeme bud\u00facnos\u0165 digit\u00e1lnej zdravotnej starostlivosti.<\/p>\n<\/div><\/div>\n\n\n\n

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\u010co pon\u00fakame<\/h2>\n\n\n\n
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Komplexn\u00fd v\u00fdvoj SaMD rie\u0161en\u00ed<\/strong><\/p>\n\n\n\n

Spolo\u010dnos\u0165 GlobalLogic sa \u0161pecializuje na vytv\u00e1ranie SaMD rie\u0161en\u00ed vyu\u017e\u00edvaj\u00facich \u00fadaje o\u00a0pacientoch na diagnostiku, lie\u010dbu a\u00a0prevenciu. Navrhujeme vysoko efekt\u00edvny softv\u00e9r pre zariaden\u00ed triedy I a\u017e III, ktor\u00fd sp\u013a\u0148a pr\u00edsne predpisy a\u00a0normy a\u00a0z\u00e1rove\u0148 prin\u00e1\u0161a intuit\u00edvne a\u00a0bezpe\u010dn\u00e9 u\u017e\u00edvate\u013esk\u00e9 prostredie.<\/p>\n<\/blockquote>\n\n\n\n

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Bezprobl\u00e9mov\u00e1 konektivita s\u00a0r\u00f4znymi zdravotn\u00edckymi zariadeniami<\/strong><\/p>\n\n\n\n

<\/div>\n\n\n\n

Na\u0161e odborn\u00e9 znalosti v\u00a0oblasti technol\u00f3gi\u00ed ako je BLE, WiFi \u010di 4G\/5G s\u00fa z\u00e1rukou bezprobl\u00e9movej konektivity medzi zdravotn\u00edckymi zariadeniami a prostriedkami a\u00a0mobiln\u00fdmi alebo cloudov\u00fdmi platformami. V\u00fdsledkom je optimaliz\u00e1cia toku \u00fadajov, zni\u017eovanie n\u00e1kladov na komunik\u00e1ciu a\u00a0zlep\u0161ovanie pou\u017eite\u013enos\u0165 zariaden\u00ed pre pacientov aj poskytovate\u013eov.<\/p>\n<\/blockquote>\n\n\n\n

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S\u00falad s\u00a0normami a\u00a0bezpe\u010dnos\u0165<\/strong><\/p>\n\n\n\n

Na\u0161e rie\u0161enia sp\u013a\u0148aj\u00fa medzin\u00e1rodn\u00e9 normy ako je ISO 13485, ISO 14971 a\u00a0IEC 62304, tak\u017ee vieme zaru\u010di\u0165, \u017ee na\u0161e SaMD rie\u0161enia s\u00fa v\u00a0s\u00falade s\u00a0relevantn\u00fdmi predpismi a\u00a0s\u00fa bezpe\u010dn\u00e9 a\u00a0pripraven\u00e9 pre glob\u00e1lny trh. V\u010faka na\u0161im bohat\u00fdm sk\u00fasenostiam so syst\u00e9mom riadenia kvality QMS dok\u00e1\u017eeme zefekt\u00edvni\u0165 proces pr\u00edpravy regula\u010dn\u00fdch dokumentov a\u00a0spravova\u0165 DHF s\u00fabory v\u00a0s\u00falade s\u00a0po\u017eiadavkami regul\u00e1tora.<\/p>\n<\/blockquote>\n\n\n\n

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V\u00fdvoj rie\u0161en\u00ed a ich optimaliz\u00e1cia pre r\u00f4zne platformy<\/strong><\/p>\n\n\n\n

SaMD rie\u0161enia spolo\u010dnosti GlobalLogic s\u00fa optimalizovan\u00e9 pre iOS, Android a\u00a0medziplatformov\u00e9 r\u00e1mce, v\u010faka \u010domu je mo\u017en\u00e9 ich nasadenie na r\u00f4zne zariadenia (BYOD model) alebo mana\u017ement \u0161pecializovan\u00fdch zariaden\u00ed. Na\u0161e odborn\u00e9 znalosti zaru\u010duj\u00fa bezprobl\u00e9mov\u00fa integr\u00e1ciu, n\u00e1kladovo efekt\u00edvnu prev\u00e1dzku a\u00a0atrakt\u00edvne u\u017e\u00edvate\u013esk\u00e9 prostredie na v\u0161etk\u00fdch platform\u00e1ch.<\/p>\n<\/blockquote>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\r\n

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V\u00fdvoj rie\u0161en\u00ed pre oblas\u0165 zdravotnej starostlivosti<\/div>\r\n

Ako pom\u00e1hame<\/h2>\r\n

Spolo\u010dnos\u0165 GlobalLogic sp\u00e1ja sily s\u00a0popredn\u00fdmi inov\u00e1tormi v\u00a0oblasti zdravotn\u00edckych technol\u00f3gi\u00ed a\u00a0zdravotnej starostlivosti, aby spolo\u010dne prin\u00e1\u0161ali \u0161pi\u010dkov\u00e9 SaMD rie\u0161enia, ktor\u00e9 zlep\u0161uj\u00fa starostlivos\u0165 o\u00a0pacientov, zefekt\u00edv\u0148uj\u00fa prev\u00e1dzkov\u00e9 \u010dinnosti a\u00a0zabezpe\u010duj\u00fa s\u00falad s\u00a0predpismi. Na\u0161e odborn\u00e9 a\u00a0praktick\u00e9 znalosti v\u00fdznamn\u00fdm sp\u00f4sobom ovplyv\u0148uj\u00fa cel\u00fd rad pr\u00edpadov pou\u017eitia, od zlep\u0161enia mana\u017ementu chronick\u00fdch ochoren\u00ed a\u017e po zaistenie konektivity \u0161pi\u010dkov\u00fdch zdravotn\u00edckych zariaden\u00ed a\u00a0pom\u00f4cok.<\/p>\r\n <\/div>\r\n <\/div>\r\n \r\n

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Nosite\u013en\u00e9 zariadenia pre monitorovanie zdravotn\u00e9ho stavu<\/h4>\n

Spolo\u010dnos\u0165 GlobalLogic vyvinula pre nadn\u00e1rodn\u00fa spolo\u010dnos\u0165 vyr\u00e1baj\u00facu zdravotn\u00edcke pom\u00f4cky flexibiln\u00fd a\u00a0roz\u0161\u00edrite\u013en\u00fd SaMD r\u00e1mec umo\u017e\u0148uj\u00faci r\u00fdchle nasadenie nosite\u013en\u00fdch a\u00a0mobiln\u00fdch aplik\u00e1ci\u00ed. Toto rie\u0161enie klientovi umo\u017e\u0148uje bezprobl\u00e9mov\u00fd zber a\u00a0\u00fapravu biometrick\u00fdch \u00fadajov, \u010d\u00edm sa \u0161etr\u00ed \u010das aj zdroje, a\u00a0z\u00e1rove\u0148 sa zlep\u0161uje u\u017e\u00edvate\u013esk\u00e1 sk\u00fasenos\u0165 pacientov.<\/p>\n <\/div>\r\n

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Ovl\u00e1da\u010d inzul\u00ednovej pumpy na mana\u017ement lie\u010dby diabetu<\/h4>\n

Spolo\u010dnos\u0165 GlobalLogic spolu so startupom zaoberaj\u00facim sa lie\u010dbou diabetu navrhli mobiln\u00fa aplik\u00e1ciu, ktor\u00e1 sa bezprobl\u00e9movo integruje s\u00a0inzul\u00ednov\u00fdmi pumpami. V\u010faka na\u0161im odborn\u00fdm znalostiam v\u00a0oblasti riadenia kvality (QMS) sme zabezpe\u010dili s\u00falad rie\u0161enia s\u00a0predpismi a\u00a0z\u00e1rove\u0148 sme pacientom poskytli n\u00e1stroj na presn\u00e9 riadenie d\u00e1vkovania inzul\u00ednu a monitoring ich zdravotn\u00e9ho stavu v\u00a0re\u00e1lnom \u010dase.<\/p>\n <\/div>\r\n

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ePRO rie\u0161enie pre onkologick\u00fdch pacientov<\/h4>\n

Spolo\u010dnos\u0165 GlobalLogic zabezpe\u010dila v\u00fdvoj cel\u00e9ho cyklu SaMD ePRO rie\u0161enia pre \u0161vaj\u010diarsky startup. N\u00e1\u0161 t\u00edm pripravil intuit\u00edvny UI\/UX dizajn pre webov\u00e9 a\u00a0mobiln\u00e9 aplik\u00e1cie, integrovan\u00e9 back-end slu\u017eby a\u00a0tie\u017e sme podporili proces certifik\u00e1cie zdravotn\u00edckych pom\u00f4cok (MDD) vo \u0160vaj\u010diarsku a\u00a0v\u00a0E\u00da, \u010d\u00edm sa zlep\u0161ila vyu\u017eite\u013enos\u0165 rie\u0161enia pre pacientov a\u00a0zefekt\u00edvnili sa procesy pre jeho klinick\u00e9 vyu\u017eitie.<\/p>\n <\/div>\r\n

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Inteligentn\u00e9 hodinky pre monitorovanie biometrick\u00fdch \u00fadajov<\/h4>\n

Spolo\u010dnos\u0165 GlobalLogic spojila sily s\u00a0popredn\u00fdm glob\u00e1lnym hr\u00e1\u010dom na trhu so zdravotn\u00edckymi pom\u00f4ckami, aby spolu vyvinuli SaMD aplik\u00e1ciu pre inteligentn\u00e9 hodinky. Vyu\u017eit\u00edm ob\u013e\u00faben\u00fdch mobiln\u00fdch platforiem sme zlep\u0161ili zapojenie pacientov, umo\u017enili zber biometrick\u00fdch \u00fadajov a\u00a0zabezpe\u010dili bezprobl\u00e9mov\u00fa integr\u00e1ciu na cloud pre lep\u0161iu anal\u00fdzu z\u00edskan\u00fdch d\u00e1t, a\u00a0t\u00fdm aj lep\u0161\u00ed mana\u017ement terapie a kontrolu jej v\u00fdsledkov.<\/p>\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/section>\r\n\n\n

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N\u00e1\u0161 poh\u013ead<\/h2>\n <\/div>\n <\/div>\n
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Presk\u00famajte inovat\u00edvne pr\u00edstupy strat\u00e9gov a v\u00fdvoj\u00e1rov z GlobalLogic.<\/p>\n Zistite viac<\/a>\n <\/div>\n <\/div>\n\n

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Blogs<\/div>
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\n \n Monitorovanie zdravotn\u00e9ho stavu na dia\u013eku \u2013 pr\u00ednosy, v\u00fdzvy a rie\u0161enia <\/a>\n <\/h3>\n
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Blogs<\/div>
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\n \n Zozn\u00e1mte sa s na\u0161\u00edm pacientom Raspberry Pi Zero <\/a>\n <\/h3>\n

Zozn\u00e1mte sa s na\u0161\u00edm pacientom Raspberry Pi Zero<\/p>

\n Cloud<\/span>Embedded Software, Hardware and Silicon Solutions<\/span>Zdravotn\u00edctvo a Life Sciences<\/span> <\/div>\n <\/div>\n \n \"Zozn\u00e1mte <\/a>\n <\/div>\n <\/div>\n
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Blogs<\/div>
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\n \n Pom\u00e1hame svetovej vede pri v\u00fdskume a v\u00fdvoji protil\u00e1tok <\/a>\n <\/h3>\n

Svojimi IT rie\u0161eniami participujeme na zlep\u0161ovan\u00ed a nap\u013a\u0148an\u00ed v\u00edzie jednej…<\/p>

\n Analytics<\/span>Data Engineering<\/span>Zdravotn\u00edctvo a Life Sciences<\/span> <\/div>\n <\/div>\n \n \"Pom\u00e1hame <\/a>\n <\/div>\n <\/div>\n \n <\/div>\n
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<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n\r\n
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\u010casto kladen\u00e9 ot\u00e1zky<\/div>\r\n
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Odpovede na v\u0161etky va\u0161e ot\u00e1zky t\u00fdkaj\u00face sa SaMD rie\u0161en\u00ed<\/h2>\r\n <\/div>\r\n <\/div>\r\n
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  • \r\n
    \u010co je Softv\u00e9r ako zdravotn\u00edcky prostriedok (SaMD)?<\/div><\/div>\r\n
    Softv\u00e9r ako zdravotn\u00edcky prostriedok\r\n\r\n(SaMD) je regulovan\u00fd softv\u00e9r ur\u010den\u00fd na\r\nmedic\u00ednske \u00fa\u010dely, ako je napr. diagnostika,\r\nlie\u010dba alebo monitorovanie pacienta. SaMD\r\nrie\u0161enia funguj\u00fa na be\u017ene pou\u017e\u00edvan\u00fdch\r\nzariadeniach, ako s\u00fa smartf\u00f3ny alebo\r\ncloudov\u00e9 platformy, a\u00a0prin\u00e1\u0161aj\u00fa inovat\u00edvne\r\nmo\u017enosti zdravotnej starostlivosti napr.\r\nv\u00a0oblasti monitorovania pacienta, anal\u00fdzy\r\nv\u00fdsledkov \u010di poskytovania personalizovanej\r\nlie\u010dby.<\/div>\r\n <\/li>\r\n
  • \r\n
    Ako GlobalLogic podporuje v\u00fdvoj SaMD rie\u0161en\u00ed?<\/div><\/div>\r\n
    Spolo\u010dnos\u0165 GlobalLogic pon\u00faka komplexn\u00e9\r\nend-to-end slu\u017eby v\u00fdvoja SaMD rie\u0161en\u00ed,\r\nvr\u00e1tane ich dizajnu, v\u00fdvoja a\u00a0komplexn\u00e9ho\r\ntestovania. \u0160pecializujeme sa na vytv\u00e1ranie\r\nintuit\u00edvnych a\u00a0bezpe\u010dn\u00fdch softv\u00e9rov\u00fdch\r\nrie\u0161en\u00ed, ktor\u00e9 sa bezprobl\u00e9movo integruj\u00fa\r\ns\u00a0r\u00f4znymi zdravotn\u00edckymi pom\u00f4ckami, s\u00fa\r\nv\u00a0s\u00falade s\u00a0glob\u00e1lne akceptovan\u00fdmi\r\nnormami, ako s\u00fa ISO 13485 a\u00a0IEC 62304,\r\na\u00a0bezpe\u010dne zlep\u0161uj\u00fa v\u00fdsledky pacientov.<\/div>\r\n <\/li>\r\n
  • \r\n
    Ak\u00e9 typy zariaden\u00ed mo\u017eno integrova\u0165 so\u00a0SaMD rie\u0161eniami?<\/div><\/div>\r\n
    SaMD rie\u0161enia sa integruj\u00fa so \u0161irokou\r\n\u0161k\u00e1lou zariaden\u00ed vr\u00e1tane nosite\u013en\u00fdch\r\nmonitorovac\u00edch pom\u00f4cok, implantovate\u013en\u00fdch\r\nzariaden\u00ed, inzul\u00ednov\u00fdch p\u00famp \u010di\r\ninteligentn\u00fdch hodiniek. Bohat\u00e9 odborn\u00e9\r\nznalosti spolo\u010dnosti GlobalLogic v\u00a0oblasti\r\ntechnol\u00f3gi\u00ed BLE, WiFi a\u00a04G\/5G zabezpe\u010duj\u00fa\r\nbezpe\u010dn\u00fa a\u00a0efekt\u00edvnu v\u00fdmenu \u00fadajov medzi\r\nt\u00fdmito zariadeniami, mobiln\u00fdmi platformami\r\na\u00a0cloudom.<\/div>\r\n <\/li>\r\n
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    Ak\u00fd pr\u00ednos maj\u00fa SaMD rie\u0161enia pre pacientov a\u00a0poskytovate\u013eov zdravotnej starostlivosti?<\/div><\/div>\r\n
    SaMD rie\u0161enia zlep\u0161uj\u00fa starostlivos\u0165\r\no\u00a0pacientov t\u00fdm, \u017ee umo\u017e\u0148uj\u00fa monitorovanie\r\nich zdravotn\u00e9ho stavu v re\u00e1lnom \u010dase,\r\nvzdialen\u00fd mana\u017ement pacienta\r\na\u00a0poskytovanie personalizovanej lie\u010dby.\r\nPoskytovate\u013eom zas prin\u00e1\u0161aj\u00fa vyu\u017eite\u013en\u00e9\r\ninform\u00e1cie, zefekt\u00edv\u0148uj\u00fa klinick\u00e9 pracovn\u00e9\r\npostupy a\u00a0zni\u017euj\u00fa prev\u00e1dzkov\u00e9 n\u00e1klady\r\nv\u010faka vyu\u017e\u00edvaniu prepojen\u00fdch syst\u00e9mov\r\na\u00a0intuit\u00edvnych u\u017e\u00edvate\u013esk\u00fdch rozhran\u00ed.<\/div>\r\n <\/li>\r\n
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    Dok\u00e1\u017ee spolo\u010dnos\u0165 GlobalLogic zabezpe\u010di\u0165 pri SaMD rie\u0161eniach ich s\u00falad s\u00a0predpismi a\u00a0normami?<\/div><\/div>\r\n
    \u00c1no, spolo\u010dnos\u0165 GlobalLogic m\u00e1 rozsiahle\r\nsk\u00fasenosti s\u00a0dodr\u017eiavan\u00edm glob\u00e1lnych\r\npredpisov a\u00a0noriem pre zdravotn\u00edcke\r\npom\u00f4cky. D\u00f4kladne pozn\u00e1me a\u00a0uplat\u0148ujeme\r\npredpisy t\u00fdkaj\u00face sa ochrany osobn\u00fdch\r\n\u00fadajov a\u00a0kybernetickej bezpe\u010dnosti, ako aj\r\npriemyseln\u00e9 normy ako ISO\u00a013485,\r\nISO\u00a014971 a\u00a0IEC\u00a062304, a\u00a0zaru\u010dujeme\r\ns\u00falad s\u00a0predpismi po\u010das cel\u00e9ho \u017eivotn\u00e9ho\r\ncyklu softv\u00e9ru. Na\u0161e odborn\u00e9 znalosti\r\nsiahaj\u00fa aj do oblasti pr\u00edpravy a\u00a0administr\u00e1cie\r\nDHF s\u00faborov a\u00a0pr\u00edpravy regul\u00e1torom\r\npo\u017eadovanej dokument\u00e1cie.<\/div>\r\n <\/li>\r\n <\/ul>\r\n <\/div>\r\n <\/section>\r\n","protected":false},"author":97,"featured_media":101619,"parent":227,"menu_order":20,"template":"","work-with-us-category":[19],"class_list":["post-101616","industries","type-industries","status-publish","has-post-thumbnail","hentry","work-with-us-category-industries"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.globallogic.com\/sk\/wp-json\/wp\/v2\/industries\/101616","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.globallogic.com\/sk\/wp-json\/wp\/v2\/industries"}],"about":[{"href":"https:\/\/www.globallogic.com\/sk\/wp-json\/wp\/v2\/types\/industries"}],"author":[{"embeddable":true,"href":"https:\/\/www.globallogic.com\/sk\/wp-json\/wp\/v2\/users\/97"}],"version-history":[{"count":3,"href":"https:\/\/www.globallogic.com\/sk\/wp-json\/wp\/v2\/industries\/101616\/revisions"}],"predecessor-version":[{"id":102901,"href":"https:\/\/www.globallogic.com\/sk\/wp-json\/wp\/v2\/industries\/101616\/revisions\/102901"}],"up":[{"embeddable":true,"href":"https:\/\/www.globallogic.com\/sk\/wp-json\/wp\/v2\/industries\/227"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.globallogic.com\/sk\/wp-json\/wp\/v2\/media\/101619"}],"wp:attachment":[{"href":"https:\/\/www.globallogic.com\/sk\/wp-json\/wp\/v2\/media?parent=101616"}],"wp:term":[{"taxonomy":"work-with-us-category","embeddable":true,"href":"https:\/\/www.globallogic.com\/sk\/wp-json\/wp\/v2\/work-with-us-category?post=101616"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}