Lai izpild\u012btu normat\u012bvo aktu pras\u012bbas daudzveid\u012bgaj\u0101 medic\u012bnas ier\u012b\u010du pasaul\u0113, ir nepiecie\u0161ama prasm\u012bga projektu vad\u012bba. Tas var b\u016bt gr\u016bts un sare\u017e\u0123\u012bts darbs. Jums ir j\u0101sabalans\u0113 daudzu da\u017e\u0101du pu\u0161u vajadz\u012bbas, vienlaikus nep\u0101rsniedzot bud\u017eetu un stingri noteiktos termi\u0146us. Kl\u012bnisk\u0101s vajadz\u012bbas un ier\u012bces dro\u0161\u012bba ir vissvar\u012bg\u0101k\u0101s, un t\u0101s ir j\u0101pier\u0101da. <\/p>\n\n\n\n
\u0100tri un konkur\u0113tsp\u0113j\u012bgi pied\u0101v\u0101jumi<\/p>\n\n\n\n
\u0100tra projekta uzs\u0101k\u0161ana<\/p>\n\n\n\n
\u0100tra piek\u013cuve apr\u012bkojumam<\/p>\n\n\n\n
Efekt\u012bva pieg\u0101de un zi\u0146o\u0161ana<\/p>\n\n\n\n
M\u0113s str\u0101d\u0101jam saska\u0146\u0101 ar ISO 17025 un LRP. P\u0113c l\u012bguma nosl\u0113g\u0161anas (pirkuma pas\u016bt\u012bjuma, darba uzdevuma vai tehnisk\u0101 l\u012bguma) m\u0113s da\u017eu dienu laik\u0101 sagatavosim protokolu j\u016bsu apstiprin\u0101\u0161anai vai koment\u0101riem.<\/p>\n\n\n\n
Medic\u012bnisko ier\u012b\u010du test\u0113\u0161ana ir process, kur\u0101 tiek pier\u0101d\u012bts, ka ier\u012bce dro\u0161i un dro\u0161i darbojas lieto\u0161anas laik\u0101.. <\/strong>Jaunu produktu izstr\u0101d\u0113 tiek veikta pla\u0161a dizaina valid\u0101cijas test\u0113\u0161ana. Tas ietver veiktsp\u0113jas test\u0113\u0161anu, toksicit\u0101tes un \u0137\u012bmisko anal\u012bzi, da\u017ek\u0101rt ar\u012b cilv\u0113ka faktoru vai pat kl\u012bnisko test\u0113\u0161anu. Past\u0101v\u012bg\u0101 kvalit\u0101tes nodro\u0161in\u0101\u0161anas test\u0113\u0161ana parasti ir ierobe\u017eot\u0101ka. T\u0101 parasti ietver izm\u0113ru p\u0101rbaudes, da\u017eus funkcion\u0101los testus un iepakojuma p\u0101rbaudi.<\/p>\n\n\n\n Veiktsp\u0113jas test\u0113\u0161ana<\/p>\n\n\n\n M\u016bsu laboratorijai ir pla\u0161a pieredze darb\u0101 ar visda\u017e\u0101d\u0101kaj\u0101m medic\u012bnas ier\u012bc\u0113m, s\u0101kot no virsmkontakta l\u012bdz pat past\u0101v\u012bgiem implantiem, k\u0101 ar\u012b ar z\u0101\u013cu pieg\u0101des produktiem, s\u0101kot no autoin\u017eektoriem l\u012bdz aerosoliem un kr\u0113miem. Laboratorijas test\u0113\u0161ana - las\u012bt vair\u0101k...<\/p>\n\n\n\n Materi\u0101lu test\u0113\u0161ana<\/p>\n\n\n\n Materi\u0101lu raksturo\u0161anai ir daudz pielietojumu medic\u012bnas ier\u012b\u010du izstr\u0101d\u0113 un ra\u017eo\u0161an\u0101. T\u0101 ir materi\u0101lu \u0137\u012bmisk\u0101 anal\u012bze, lai noteiktu \u2019pirkstu nospiedumu\u2019. \u0160o inform\u0101ciju p\u0113c tam izmanto, lai l\u012bdz minimumam samazin\u0101tu jaunu konstrukciju toksikolo\u0123isko test\u0113\u0161anu, k\u0101 ar\u012b ra\u017eo\u0161anas un konstrukcijas izmai\u0146u veik\u0161anai. \u0136\u012bmisk\u0101 identifik\u0101cija j\u0101piem\u0113ro ar\u012b ien\u0101ko\u0161aj\u0101m izejviel\u0101m un ra\u017eo\u0161an\u0101 no partijas uz partiju. <\/p>\n\n\n\n Biolo\u0123isk\u0101s sader\u012bbas test\u0113\u0161ana<\/p>\n\n\n\n Medic\u012bniskaj\u0101m ier\u012bc\u0113m ir j\u0101veic da\u017e\u0101das pak\u0101pes biolo\u0123isk\u0101s sader\u012bbas testi atkar\u012bb\u0101 no to klasifik\u0101cijas. Galvenais vadl\u012bniju avots par biolo\u0123isk\u0101s dro\u0161\u012bbas pamatpras\u012bb\u0101m ir ISO 10993 - Medic\u012bnisko ier\u012b\u010du biolo\u0123isk\u0101 nov\u0113rt\u0113\u0161ana. \u0160is standarts defin\u0113 ier\u012bces, \u0146emot v\u0113r\u0101 to invazivit\u0101ti un saskares ilgumu ar pacientu, kas p\u0113c tam nosaka, k\u0101da l\u012bme\u0146a dro\u0161\u012bbas testi ra\u017eot\u0101jiem ir sekm\u012bgi j\u0101veic pirms ier\u012bces lai\u0161anas tirg\u016b. Dro\u0161\u012bbas test\u0113\u0161ana - las\u012bt vair\u0101k...<\/p>\n\n\n\n Pirm\u0101s l\u012bnijas QA<\/p>\n\n\n\n Vai s\u016bdz\u012bbas par produktiem novirza darbasp\u0113ku un pat\u0113r\u0113 resursus, kurus j\u016bs lab\u0101k t\u0113r\u0113tu citur? Klientu atgrie\u0161an\u0101s ir neizb\u0113gama uz\u0146\u0113m\u0113jdarb\u012bbas sast\u0101vda\u013ca, bet tai nav j\u0101b\u016bt neat\u0146emamai j\u016bsu uz\u0146\u0113m\u0113jdarb\u012bbas sast\u0101vda\u013cai! M\u016bsu unik\u0101lais pirm\u0101s l\u012bnijas kvalit\u0101tes nodro\u0161in\u0101\u0161anas pakalpojums \u013cauj viegli izpild\u012bt ES MEDDEV 2.12-1 Rev. 5 \u201cVadl\u012bnijas par medic\u012bnisko ier\u012b\u010du vigilances sist\u0113mu\u201d, kas nosaka, ka \u201cjebkuram ra\u017eot\u0101jam, kas p\u0101rdod Eiropas tirg\u016b, ir j\u0101nodro\u0161ina, ka t\u0101 vigilance. S\u016bdz\u012bbu anal\u012bze - las\u012bt vair\u0101k...<\/p>\n\n\n\n 2021. gada 26. maij\u0101 Medic\u012bnisko ier\u012b\u010du direkt\u012bvu (MDD) aizst\u0101ja jaun\u0101 Medic\u012bnisko ier\u012b\u010du regula (MDR). MDR ir iecer\u0113ta k\u0101 uzlabota MDD versija, un galven\u0101 at\u0161\u0137ir\u012bba ir t\u0101, ka MDR k\u0101 regulai ir nepiecie\u0161ama tie\u0161a \u012bsteno\u0161ana vis\u0101s ES dal\u012bbvalst\u012bs. Tas \u013cauj ar MDR izveidot vienotu un taisn\u012bgu regul\u0113jumu vis\u0101m dal\u012bbvalst\u012bm un paaugstin\u0101t kvalit\u0101tes un dro\u0161\u012bbas pas\u0101kumu standartus.<\/p>\n\n\n\n MDR ne tikai attieksies uz vis\u0101m ES dal\u012bbvalst\u012bm, bet ar\u012b t\u0101s sniegt\u0101s vadl\u012bnijas mudin\u0101s uz\u0146\u0113mumus r\u012bkoties un uzlabot savu pa\u0161reiz\u0113jo produktu higi\u0113nu un dro\u0161\u012bbu, kam vajadz\u0113tu iev\u0113rojami uzlabot to visp\u0101r\u0113jos standartus.<\/p>\n\n\n\n Regulas noteikumi paredz, ka uz\u0146\u0113mumiem j\u0101p\u0101rskata savi portfe\u013ci un j\u0101veic nepiecie\u0161am\u0101s izmai\u0146as, lai tie atbilstu noteikumiem.<\/p>\n\n\n\n Uz medic\u012bniskaj\u0101m ier\u012bc\u0113m attiecas vair\u0101kas normat\u012bv\u0101s pras\u012bbas, lai aizsarg\u0101tu lietot\u0101ju, pacientu un tre\u0161o personu vesel\u012bbu.<\/p>\n\n\n\n \u0160eit ir uzskait\u012btas vissvar\u012bg\u0101k\u0101s pras\u012bbas:<\/p>\n\n\n\n \u012apa\u0161a testa pl\u0101na pier\u0101d\u012bjums saska\u0146\u0101 ar DIN EN ISO 14155.<\/p>\n\n\n\n Apliecin\u0101jums par attiec\u012bg\u0101 produkta nekait\u012bgumu.<\/p>\n\n\n\n Kompetent\u0101s augst\u0101k\u0101s feder\u0101l\u0101s iest\u0101des BfArM apstiprin\u0101jums (MPG 22.a pants)<\/p>\n\n\n\n \u0112tikas komitejas apstiprin\u0101jums<\/p>\n\n\n\n Pacienta inform\u0113\u0161ana un piekri\u0161ana<\/p>\n\n\n\n Apdro\u0161in\u0101\u0161anas probanda nosl\u0113g\u0161ana<\/p>\n\n\n\n Amerikas Savienotaj\u0101s Valst\u012bs par Amerikas Savienotaj\u0101s Valst\u012bs rad\u012bto un p\u0101rdoto medic\u012bnisko ier\u012b\u010du regul\u0113\u0161anu ir atbild\u012bgs FDA Ier\u012b\u010du un radiolo\u0123isk\u0101s vesel\u012bbas centrs (CDRH).<\/p>\n\n\n\n Medic\u012bnisk\u0101s ier\u012bces Amerikas Savienotaj\u0101s Valst\u012bs ir iedal\u012btas pa klas\u0113m (I, II un III). \u0160\u012bs klases nosaka, k\u0101das normat\u012bv\u0101s pras\u012bbas ier\u012bcei vai tehnolo\u0123ijai ir j\u0101iev\u0113ro. Visiem ra\u017eot\u0101jiem un izplat\u012bt\u0101jiem no 1. oktobra l\u012bdz 31. decembrim ir j\u0101re\u0123istr\u0113jas FDA. Re\u0123istr\u0113jot medic\u012bnisko ier\u012bci, jums ir j\u0101nor\u0101da visi uz\u0146\u0113mumi, kas iesaist\u012bti produkta rad\u012b\u0161an\u0101, tostarp iepakot\u0101ji, ra\u017eot\u0101ji, mar\u0137\u0113t\u0101ji, izstr\u0101d\u0101t\u0101ji un steriliz\u0113t\u0101ji.<\/p>\n\n\n\n Atkar\u012bb\u0101 no t\u0101, k\u0101dai klasei pieder j\u016bsu medic\u012bnas ier\u012bce, jums b\u016bs j\u0101iesniedz pazi\u0146ojums pirms lai\u0161anas tirg\u016b, k\u0101 ar\u012b citi noteikumi, piem\u0113ram, PMA p\u0101rskat\u012b\u0161ana un tre\u0161\u0101s puses p\u0101rskat\u012b\u0161ana.<\/p>\n\n\n\n Amerikas Savienotaj\u0101s Valst\u012bs FDA ir j\u0101zi\u0146o par visiem gad\u012bjumiem, kad medic\u012bnas ier\u012bce ir izrais\u012bjusi vai veicin\u0101jusi personas traumu vai n\u0101vi. J\u0101zi\u0146o par visiem darb\u012bbas trauc\u0113jumiem, lai tos var\u0113tu nov\u0113rst.<\/p>\n\n\n\n ASV P\u0101rtikas un z\u0101\u013cu p\u0101rvaldei (FDA) ir vair\u0101ki noteikumi, kas \u012bpa\u0161i attiecas uz medic\u012bnas ier\u012b\u010du programmat\u016bras test\u0113\u0161anu. \u0160ie noteikumi nodro\u0161ina, ka medic\u012bnas ier\u012b\u010du programmat\u016bra ir dro\u0161a, efekt\u012bva un uzticama, un rezult\u0101ti parasti tiek iesniegti a\u0123ent\u016brai.<\/p>\n\n\n\n Viens no svar\u012bgiem noteikumiem ir FDA Vadl\u012bnijas par medic\u012bniskaj\u0101s ier\u012bc\u0113s iek\u013caut\u0101s programmat\u016bras pirmsp\u0101rdo\u0161anas iesniegumu saturu. \u0160ajos nor\u0101d\u012bjumos ir izkl\u0101st\u012bta inform\u0101cija, kas j\u0101iek\u013cauj medic\u012bnisko ier\u012b\u010du programmat\u016bras pirmsp\u0101rdo\u0161anas iesniegumos, tostarp s\u012bk\u0101ka inform\u0101cija par programmat\u016bras paredz\u0113to lietojumu, ier\u012bces b\u012bstam\u012bbas anal\u012bze un test\u0113\u0161anas protokoli.<\/p>\n\n\n\n V\u0113l viens svar\u012bgs regul\u0113jums ir FDA Visp\u0101r\u012bgie programmat\u016bras valid\u0113\u0161anas principi, kas sniedz nor\u0101d\u012bjumus par programmat\u016bras valid\u0113\u0161anu izmanto\u0161anai medic\u012bnas ier\u012bc\u0113s. Noteikumos apl\u016bkoti t\u0101di jaut\u0101jumi k\u0101 programmat\u016bras izstr\u0101des dz\u012bves cikls, dokument\u0101cija un test\u0113\u0161anas metodes.<\/p>\n\n\n\n Papildus \u0161iem noteikumiem FDA ir izstr\u0101d\u0101jusi \u012bpa\u0161us nor\u0101d\u012bjumus par programmat\u016bras izmai\u0146\u0101m eso\u0161aj\u0101s medic\u012bnas ier\u012bc\u0113s. \u0160aj\u0101s vadl\u012bnij\u0101s ir izkl\u0101st\u012bti procesi, kas medic\u012bnas ier\u012b\u010du ra\u017eot\u0101jiem j\u0101iev\u0113ro, veicot izmai\u0146as jau tirg\u016b eso\u0161aj\u0101 programmat\u016br\u0101.<\/p>\n\n\n\n Ar akt\u012bvu attieksmi uz\u0146\u0113mums koncentr\u0113jas uz klientu interes\u0113m, nep\u0101rtraukti uzlabo produktus, lai apmierin\u0101tu klientu vajadz\u012bbas, un piev\u0113r\u0161 uzman\u012bbu dro\u0161\u012bbas, uzticam\u012bbas, vides aizsardz\u012bbas pras\u012bb\u0101m un inov\u0101cij\u0101m. Caurlaid\u012bbas testeris<\/a>,Adatas iespie\u0161anas testa metode<\/a>,Medic\u012bnas produktu test\u0113\u0161anas instrumentu ra\u017eot\u0101js<\/a>,Medic\u012bnisko ier\u012b\u010du testeris<\/a>,Stiepes testera ra\u017eot\u0101js<\/a>,Manu\u0101lais karboniz\u0101cijas testeris<\/a>,CO2 tilpuma testeris<\/a>,Medic\u012bnas adatu punkcijas testeris<\/a>,Ku\u0161anas pl\u016bsmas indeksa testera cena<\/a>,Horizont\u0101lais stiepes testera pieg\u0101d\u0101t\u0101js<\/a>,Motoriz\u0113ts v\u0101ci\u0146u griezes momenta testeris<\/a>,Griezes momenta test\u0113\u0161anas iek\u0101rta<\/a><\/p>","protected":false},"excerpt":{"rendered":" Medical Device Function and Performance Testing Meeting regulatory requirements in the varied world of medical devices requires deft project management. This can be a difficult and complex job. You have to balance the needs of a lot of different parties whilst staying within budget and holding to tight deadlines. The clinical needs and safety of […]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1124","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/posts\/1124","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/comments?post=1124"}],"version-history":[{"count":0,"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/posts\/1124\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/media?parent=1124"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/categories?post=1124"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/tags?post=1124"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Medic\u012bnisko ier\u012b\u010du test\u0113\u0161ana<\/h2>\n\n\n\n
Piln\u012bga rokasgr\u0101mata par programmat\u016bras test\u0113\u0161anu medic\u012bnas ier\u012b\u010du nozar\u0113<\/h2>\n\n\n\n
<\/h3>\n\n\n\n