Spln\u011bn\u00ed regula\u010dn\u00edch po\u017eadavk\u016f v rozmanit\u00e9m sv\u011bt\u011b zdravotnick\u00fdch prost\u0159edk\u016f vy\u017eaduje obratn\u00e9 \u0159\u00edzen\u00ed projekt\u016f. To m\u016f\u017ee b\u00fdt obt\u00ed\u017en\u00e1 a slo\u017eit\u00e1 pr\u00e1ce. Mus\u00edte sladit pot\u0159eby mnoha r\u016fzn\u00fdch stran a z\u00e1rove\u0148 dodr\u017eet rozpo\u010det a kr\u00e1tk\u00e9 term\u00edny. Klinick\u00e9 pot\u0159eby a bezpe\u010dnost p\u0159\u00edstroje jsou prvo\u0159ad\u00e9 a mus\u00ed b\u00fdt prok\u00e1z\u00e1ny. <\/p>\n\n\n\n
Rychl\u00e9 a konkurenceschopn\u00e9 nab\u00eddky<\/p>\n\n\n\n
Rychl\u00e9 zah\u00e1jen\u00ed projektu<\/p>\n\n\n\n
Rychl\u00fd p\u0159\u00edstup k vybaven\u00ed<\/p>\n\n\n\n
Efektivn\u00ed doru\u010dov\u00e1n\u00ed a pod\u00e1v\u00e1n\u00ed zpr\u00e1v<\/p>\n\n\n\n
Pracujeme podle norem ISO 17025 a GMP. Jakmile je uzav\u0159ena smlouva (objedn\u00e1vka, v\u00fdkaz pr\u00e1ce nebo technick\u00e1 dohoda), do n\u011bkolika dn\u016f v\u00e1m za\u0161leme protokol ke schv\u00e1len\u00ed nebo k p\u0159ipom\u00ednk\u00e1m.<\/p>\n\n\n\n
Testov\u00e1n\u00ed zdravotnick\u00e9ho prost\u0159edku je proces, kter\u00fd prokazuje, \u017ee prost\u0159edek bude p\u0159i pou\u017e\u00edv\u00e1n\u00ed spolehliv\u011b a bezpe\u010dn\u011b fungovat.. <\/strong>P\u0159i v\u00fdvoji nov\u00fdch v\u00fdrobk\u016f se pou\u017e\u00edv\u00e1 rozs\u00e1hl\u00e9 testov\u00e1n\u00ed validace n\u00e1vrhu. To zahrnuje testov\u00e1n\u00ed v\u00fdkonu, anal\u00fdzu toxicity a chemickou anal\u00fdzu a n\u011bkdy i testov\u00e1n\u00ed lidsk\u00e9ho faktoru nebo dokonce klinick\u00e9 testov\u00e1n\u00ed. Pr\u016fb\u011b\u017en\u00e9 testov\u00e1n\u00ed zaji\u0161t\u011bn\u00ed kvality je obecn\u011b omezen\u011bj\u0161\u00ed. Obvykle zahrnuje rozm\u011brov\u00e9 kontroly, n\u011bkter\u00e9 funk\u010dn\u00ed testy a ov\u011b\u0159en\u00ed balen\u00ed.<\/p>\n\n\n\n Testov\u00e1n\u00ed v\u00fdkonu<\/p>\n\n\n\n Na\u0161e laborato\u0159 m\u00e1 rozs\u00e1hl\u00e9 zku\u0161enosti s nejr\u016fzn\u011bj\u0161\u00edmi zdravotnick\u00fdmi prost\u0159edky, od povrchov\u00fdch kontakt\u016f po trval\u00e9 implant\u00e1ty, a tak\u00e9 s produkty pro pod\u00e1v\u00e1n\u00ed l\u00e9k\u016f, od autoinjektor\u016f po spreje a kr\u00e9my. Laboratorn\u00ed testov\u00e1n\u00ed - v\u00edce informac\u00ed...<\/p>\n\n\n\n Zkou\u0161en\u00ed materi\u00e1l\u016f<\/p>\n\n\n\n Charakterizace materi\u00e1l\u016f m\u00e1 mnohostrann\u00e9 vyu\u017eit\u00ed p\u0159i v\u00fdvoji a v\u00fdrob\u011b zdravotnick\u00fdch prost\u0159edk\u016f. Jedn\u00e1 se o chemickou anal\u00fdzu materi\u00e1l\u016f za \u00fa\u010delem identifikace \u2019otisku prstu\u2019. Tyto informace se pak vyu\u017e\u00edvaj\u00ed k minimalizaci toxikologick\u00fdch zkou\u0161ek nov\u00fdch n\u00e1vrh\u016f i k v\u00fdrobn\u00edm a konstruk\u010dn\u00edm zm\u011bn\u00e1m. Chemick\u00e1 identifikace by se m\u011bla uplat\u0148ovat tak\u00e9 u vstupn\u00edch surovin a p\u0159i v\u00fdrob\u011b jednotliv\u00fdch \u0161ar\u017e\u00ed. <\/p>\n\n\n\n Testov\u00e1n\u00ed biokompatibility<\/p>\n\n\n\n Zdravotnick\u00e9 prost\u0159edky vy\u017eaduj\u00ed r\u016fzn\u00fd stupe\u0148 testov\u00e1n\u00ed biokompatibility v z\u00e1vislosti na jejich klasifikaci. Hlavn\u00edm zdrojem pokyn\u016f k z\u00e1kladn\u00edm po\u017eadavk\u016fm na biologickou bezpe\u010dnost je norma ISO 10993 - Biologick\u00e9 hodnocen\u00ed zdravotnick\u00fdch prost\u0159edk\u016f. Tato norma definuje prost\u0159edky z hlediska jejich invazivity a d\u00e9lky kontaktu s pacientem, co\u017e n\u00e1sledn\u011b ur\u010duje, jakou \u00farove\u0148 testov\u00e1n\u00ed bezpe\u010dnosti mus\u00ed v\u00fdrobci \u00fasp\u011b\u0161n\u011b absolvovat p\u0159ed uveden\u00edm sv\u00e9ho prost\u0159edku na trh. Testov\u00e1n\u00ed bezpe\u010dnosti - v\u00edce informac\u00ed...<\/p>\n\n\n\n Kontrola kvality v prvn\u00ed linii<\/p>\n\n\n\n Odv\u00e1d\u011bj\u00ed reklamace produkt\u016f pracovn\u00ed s\u00edlu a spot\u0159ebov\u00e1vaj\u00ed zdroje, kter\u00e9 byste rad\u011bji vynalo\u017eili jinde? Vracen\u00ed zbo\u017e\u00ed z\u00e1kazn\u00edky je nevyhnutelnou sou\u010d\u00e1st\u00ed podnik\u00e1n\u00ed, ale nemus\u00ed b\u00fdt ned\u00edlnou sou\u010d\u00e1st\u00ed toho va\u0161eho! Na\u0161e jedine\u010dn\u00e1 slu\u017eba First Line QA umo\u017e\u0148uje snadno splnit po\u017eadavky sm\u011brnice EU MEDDEV 2.12-1 Rev. 5 \u201cGuidelines on a medical device vigilance system\u201d, kter\u00e1 stanov\u00ed, \u017ee \u201cka\u017ed\u00fd v\u00fdrobce prod\u00e1vaj\u00edc\u00ed na evropsk\u00e9m trhu by m\u011bl zajistit, aby jeho vigilance. Anal\u00fdza st\u00ed\u017enost\u00ed - v\u00edce informac\u00ed...<\/p>\n\n\n\n Dne 26. kv\u011btna 2021 byla sm\u011brnice o zdravotnick\u00fdch prost\u0159edc\u00edch (MDD) nahrazena nov\u00fdm na\u0159\u00edzen\u00edm o zdravotnick\u00fdch prost\u0159edc\u00edch (MDR). MDR m\u00e1 b\u00fdt vylep\u0161enou verz\u00ed MDD, p\u0159i\u010dem\u017e hlavn\u00ed rozd\u00edl spo\u010d\u00edv\u00e1 v tom, \u017ee MDR jako na\u0159\u00edzen\u00ed vy\u017eaduje p\u0159\u00edmou implementaci ve v\u0161ech \u010dlensk\u00fdch st\u00e1tech EU. To umo\u017e\u0148uje, aby MDR vytvo\u0159ilo jednotnou a spravedlivou regulaci pro v\u0161echny \u010dlensk\u00e9 st\u00e1ty a zv\u00fd\u0161ilo standardy pro opat\u0159en\u00ed v oblasti kvality a bezpe\u010dnosti.<\/p>\n\n\n\n Nejen\u017ee se MDR roz\u0161\u00ed\u0159\u00ed na v\u0161echny \u010dlensk\u00e9 st\u00e1ty EU, ale pokyny, kter\u00e9 poskytuje, tak\u00e9 povzbud\u00ed spole\u010dnosti k tomu, aby jednaly a zlep\u0161ily svou sou\u010dasnou hygienu a bezpe\u010dnost v\u00fdrobk\u016f, co\u017e by m\u011blo v\u00fdrazn\u011b zlep\u0161it jejich celkovou \u00farove\u0148.<\/p>\n\n\n\n Ustanoven\u00ed na\u0159\u00edzen\u00ed vy\u017eaduj\u00ed, aby spole\u010dnosti p\u0159ezkoumaly sv\u00e1 portfolia a provedly nezbytn\u00e9 zm\u011bny, aby splnily po\u017eadavky na\u0159\u00edzen\u00ed.<\/p>\n\n\n\n Zdravotnick\u00e9 prost\u0159edky podl\u00e9haj\u00ed n\u011bkolika regula\u010dn\u00edm po\u017eadavk\u016fm na ochranu zdrav\u00ed u\u017eivatel\u016f, pacient\u016f a t\u0159et\u00edch stran.<\/p>\n\n\n\n Zde uv\u00e1d\u00edme nejd\u016fle\u017eit\u011bj\u0161\u00ed po\u017eadavky:<\/p>\n\n\n\n Prok\u00e1z\u00e1n\u00ed specializovan\u00e9ho pl\u00e1nu zkou\u0161ek podle DIN EN ISO 14155<\/p>\n\n\n\n D\u016fkaz o bezpe\u010dnosti dan\u00e9ho v\u00fdrobku.<\/p>\n\n\n\n Schv\u00e1len\u00ed p\u0159\u00edslu\u0161n\u00fdm vy\u0161\u0161\u00edm spolkov\u00fdm org\u00e1nem BfArM (\u00a7 22a MPG)<\/p>\n\n\n\n Schv\u00e1len\u00ed etickou komis\u00ed<\/p>\n\n\n\n Informace a souhlas pacienta<\/p>\n\n\n\n Uzav\u0159en\u00ed poji\u0161t\u011bn\u00ed probanda<\/p>\n\n\n\n Ve Spojen\u00fdch st\u00e1tech je za regulaci zdravotnick\u00fdch prost\u0159edk\u016f vytvo\u0159en\u00fdch a prod\u00e1van\u00fdch ve Spojen\u00fdch st\u00e1tech zodpov\u011bdn\u00e9 Centrum pro zdravotnick\u00e9 prost\u0159edky a radiologick\u00e9 zdrav\u00ed (CDRH) \u00fa\u0159adu FDA.<\/p>\n\n\n\n Zdravotnick\u00e9 prost\u0159edky jsou ve Spojen\u00fdch st\u00e1tech definov\u00e1ny podle t\u0159\u00edd (I, II a III). Tyto t\u0159\u00eddy ur\u010duj\u00ed, jak\u00e9 po\u017eadavky na p\u0159edpisy mus\u00ed p\u0159\u00edstroj nebo technologie spl\u0148ovat. V\u0161ichni v\u00fdrobci a distributo\u0159i se mus\u00ed registrovat u FDA v obdob\u00ed od 1. \u0159\u00edjna do 31. prosince. P\u0159i registraci zdravotnick\u00e9ho prost\u0159edku mus\u00edte uv\u00e9st seznam v\u0161ech spole\u010dnost\u00ed, kter\u00e9 se pod\u00edlej\u00ed na tvorb\u011b v\u00fdrobku, co\u017e zahrnuje bal\u00edrny, v\u00fdrobce, \u0161t\u00edtkova\u010de, v\u00fdvoj\u00e1\u0159e a steriliz\u00e1tory.<\/p>\n\n\n\n V z\u00e1vislosti na tom, do jak\u00e9 t\u0159\u00eddy pat\u0159\u00ed v\u00e1\u0161 zdravotnick\u00fd prost\u0159edek, budete muset p\u0159edlo\u017eit ozn\u00e1men\u00ed p\u0159ed uveden\u00edm na trh spolu s dal\u0161\u00edmi p\u0159edpisy, jako je p\u0159ezkum PMA a p\u0159ezkum t\u0159et\u00ed stranou.<\/p>\n\n\n\n Ve Spojen\u00fdch st\u00e1tech je nutn\u00e9 nahl\u00e1sit \u00fa\u0159adu FDA ka\u017edou ud\u00e1lost, kdy zdravotnick\u00fd prost\u0159edek zp\u016fsobil nebo p\u0159isp\u011bl ke zran\u011bn\u00ed nebo \u00famrt\u00ed osoby. Ve\u0161ker\u00e9 z\u00e1vady mus\u00ed b\u00fdt hl\u00e1\u0161eny, aby mohly b\u00fdt odstran\u011bny.<\/p>\n\n\n\n Americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) m\u00e1 n\u011bkolik p\u0159edpis\u016f, kter\u00e9 se konkr\u00e9tn\u011b t\u00fdkaj\u00ed testov\u00e1n\u00ed softwaru pro zdravotnick\u00e9 prost\u0159edky. Tyto p\u0159edpisy zaji\u0161\u0165uj\u00ed, aby byl software pro zdravotnick\u00e9 prost\u0159edky bezpe\u010dn\u00fd, \u00fa\u010dinn\u00fd a spolehliv\u00fd, a jejich v\u00fdsledky se zpravidla p\u0159edkl\u00e1daj\u00ed agentu\u0159e.<\/p>\n\n\n\n Jedn\u00edm z d\u016fle\u017eit\u00fdch p\u0159edpis\u016f jsou Pokyny FDA pro obsah p\u0159edkl\u00e1dan\u00fdch materi\u00e1l\u016f p\u0159ed uveden\u00edm na trh pro software obsa\u017een\u00fd ve zdravotnick\u00fdch prost\u0159edc\u00edch. Tento pokyn uv\u00e1d\u00ed informace, kter\u00e9 by m\u011bly b\u00fdt obsa\u017eeny v dokumentech p\u0159edkl\u00e1dan\u00fdch p\u0159ed uveden\u00edm na trh pro software zdravotnick\u00fdch prost\u0159edk\u016f, v\u010detn\u011b podrobnost\u00ed o zam\u00fd\u0161len\u00e9m pou\u017eit\u00ed softwaru, anal\u00fdzy nebezpe\u010d\u00ed pro za\u0159\u00edzen\u00ed a protokol\u016f o testov\u00e1n\u00ed.<\/p>\n\n\n\n Dal\u0161\u00edm kl\u00ed\u010dov\u00fdm p\u0159edpisem jsou Obecn\u00e9 z\u00e1sady validace softwaru \u00fa\u0159adu FDA, kter\u00e9 poskytuj\u00ed pokyny pro validaci softwaru pro pou\u017eit\u00ed ve zdravotnick\u00fdch prost\u0159edc\u00edch. Na\u0159\u00edzen\u00ed se zab\u00fdv\u00e1 t\u00e9maty, jako je \u017eivotn\u00ed cyklus v\u00fdvoje softwaru, dokumentace a metody testov\u00e1n\u00ed.<\/p>\n\n\n\n Krom\u011b t\u011bchto p\u0159edpis\u016f m\u00e1 FDA k dispozici i specifick\u00e9 pokyny pro zm\u011bny softwaru st\u00e1vaj\u00edc\u00edch zdravotnick\u00fdch prost\u0159edk\u016f. Tyto pokyny popisuj\u00ed postupy, kter\u00e9 by m\u011bli v\u00fdrobci zdravotnick\u00fdch prost\u0159edk\u016f dodr\u017eovat p\u0159i prov\u00e1d\u011bn\u00ed zm\u011bn softwaru, kter\u00fd je ji\u017e na trhu.<\/p>\n\n\n\n S proaktivn\u00edm p\u0159\u00edstupem se spole\u010dnost zam\u011b\u0159uje na z\u00e1jmy z\u00e1kazn\u00edk\u016f, neust\u00e1le zdokonaluje v\u00fdrobky, aby vyhovovaly jejich pot\u0159eb\u00e1m, a d\u00e1le db\u00e1 na bezpe\u010dnost, spolehlivost, po\u017eadavky na ochranu \u017eivotn\u00edho prost\u0159ed\u00ed a inovace. Tester pronikavosti<\/a>,Zku\u0161ebn\u00ed metoda penetrace jehlou<\/a>,V\u00fdrobce n\u00e1stroj\u016f pro testov\u00e1n\u00ed l\u00e9ka\u0159sk\u00fdch v\u00fdrobk\u016f<\/a>,Tester zdravotnick\u00fdch prost\u0159edk\u016f<\/a>,V\u00fdrobce tahov\u00fdch zkou\u0161e\u010dek<\/a>,Ru\u010dn\u00ed tester sycen\u00ed<\/a>,Tester objemu CO2<\/a>,Tester vpichu l\u00e9ka\u0159sk\u00e9 jehly<\/a>,Tester indexu toku taveniny Cena<\/a>,Dodavatel horizont\u00e1ln\u00edho tahov\u00e9ho testeru<\/a>,Motorizovan\u00e1 zkou\u0161e\u010dka kroutic\u00edho momentu uz\u00e1v\u011bru<\/a>,Zku\u0161ebn\u00ed stroj na kroutic\u00ed moment<\/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:\/\/test.geo-tester.com\/cs\/wp-json\/wp\/v2\/posts\/1124","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/test.geo-tester.com\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/test.geo-tester.com\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/test.geo-tester.com\/cs\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/test.geo-tester.com\/cs\/wp-json\/wp\/v2\/comments?post=1124"}],"version-history":[{"count":0,"href":"https:\/\/test.geo-tester.com\/cs\/wp-json\/wp\/v2\/posts\/1124\/revisions"}],"wp:attachment":[{"href":"https:\/\/test.geo-tester.com\/cs\/wp-json\/wp\/v2\/media?parent=1124"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/test.geo-tester.com\/cs\/wp-json\/wp\/v2\/categories?post=1124"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/test.geo-tester.com\/cs\/wp-json\/wp\/v2\/tags?post=1124"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Testov\u00e1n\u00ed zdravotnick\u00fdch prost\u0159edk\u016f<\/h2>\n\n\n\n
Kompletn\u00ed pr\u016fvodce testov\u00e1n\u00edm softwaru v odv\u011btv\u00ed zdravotnick\u00fdch prost\u0159edk\u016f<\/h2>\n\n\n\n
<\/h3>\n\n\n\n