{"id":89,"date":"2021-03-24T09:39:25","date_gmt":"2021-03-24T08:39:25","guid":{"rendered":"http:\/\/www.meliora-compliance.com\/?page_id=89"},"modified":"2023-09-26T16:05:07","modified_gmt":"2023-09-26T14:05:07","slug":"services","status":"publish","type":"page","link":"https:\/\/www.meliora-compliance.com\/czech\/services\/","title":{"rendered":"Slu\u017eby"},"content":{"rendered":"
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Na\u0161e slu\u017eby<\/b><\/h2>

Na\u0161e \u0161irok\u00e9 znalosti a v\u00edce ne\u017e 24 let zku\u0161enost\u00ed vyu\u017e\u00edv\u00e1me k navigaci na\u0161ich klient\u016f cel\u00fdm procesem od rann\u00fdch f\u00e1z\u00ed v\u00fdvoje prost\u0159edku a\u017e po jeho distribuci a n\u00e1sledn\u00e9 sledov\u00e1n\u00ed po uveden\u00ed na trh. Na\u0161e hlavn\u00ed zam\u011b\u0159en\u00ed jsou trhy v EU a v USA.<\/span><\/p>

Na\u0161imi z\u00e1kazn\u00edky jsou mal\u00e9 za\u010d\u00ednaj\u00edc\u00ed spole\u010dnosti i velc\u00ed zaveden\u00ed v\u00fdrobci a distributo\u0159i.<\/span><\/p>

N\u00e1\u0161 p\u0159\u00edstup je v\u017edy praktick\u00fd, a z\u00e1rove\u0148 se za ka\u017ed\u00fdch okolnost\u00ed zam\u011b\u0159ujeme na bezpe\u010dnost pacient\u016f, efektivn\u00ed syst\u00e9m \u0159\u00edzen\u00ed kvality, nejrychlej\u0161\u00ed cestu prost\u0159edku na trh a spr\u00e1vnou rovnov\u00e1hu mezi obchodn\u00edmi pot\u0159ebami z\u00e1kazn\u00edk\u016f a platn\u00fdmi regula\u010dn\u00edmi po\u017eadavky.<\/span><\/p>

Pokud chcete vyhov\u011bt nejnov\u011bj\u0161\u00edm regulatorn\u00edm po\u017eadavk\u016fm na zdravotnick\u00e9 prost\u0159edky, nebo zav\u00e9st efektivn\u00ed syst\u00e9m \u0159\u00edzen\u00ed kvality, kontaktujte n\u00e1s. Zanalyzujeme va\u0161i popt\u00e1vku a poskytneme v\u00e1m efektivn\u00ed nab\u00eddku pro v\u00e1\u0161 projekt.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Regulatorn\u00ed strategie<\/a><\/h3>

Zohledn\u011bn\u00ed regulatorn\u00edch po\u017eadavk\u016f je velmi d\u016fle\u017eit\u00e9 pro ka\u017edou firmu, kter\u00e1 m\u00e1 v \u00famyslu navrhnout, vyvinout a prod\u00e1vat zdravotnick\u00fd prost\u0159edek.<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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CE zna\u010dka - schv\u00e1len\u00ed pro EU<\/a><\/h3>

Aby mohl b\u00fdt zdravotnick\u00fd prost\u0159edek uveden na trh v EU, mus\u00ed pro n\u011bj v\u00fdrobce z\u00edskat CE zna\u010dku. Ozna\u010den\u00ed shody CE je d\u016fkazem toho, \u017ee produkt vyhovuje platn\u00fdm z\u00e1kon\u016fm a p\u0159edpis\u016fm EU. V sou\u010dasn\u00e9 dob\u011b je CE zna\u010dka vy\u017eadov\u00e1na ve v\u00edce ne\u017e 30 evropsk\u00fdch zem\u00edch.<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Schv\u00e1len\u00ed pro USA<\/a><\/h3>

USA jsou nejv\u011bt\u0161\u00edm sv\u011btov\u00fdm trhem se zdravotnick\u00fdmi prost\u0159edky. Prost\u0159edky prod\u00e1van\u00e9 ve Spojen\u00fdch st\u00e1tech podl\u00e9haj\u00ed regulatorn\u00edm po\u017eadavk\u016fm Feder\u00e1ln\u00edho \u00fa\u0159adu pro potraviny a l\u00e9\u010diva (FDA). Se zam\u011b\u0159en\u00edm na v\u00fdrobce v EU, kte\u0159\u00ed maj\u00ed v \u00famyslu prod\u00e1vat v USA, v\u00e1m Meliora Compliance pom\u016f\u017ee z\u00edskat regulatorn\u00ed schv\u00e1len\u00ed pro v\u00e1\u0161 prost\u0159edek v USA.<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Syst\u00e9m \u0159\u00edzen\u00ed kvality (QMS)<\/a><\/h3>

Zaveden\u00ed a \u00fadr\u017eba syst\u00e9mu \u0159\u00edzen\u00ed kvality (QMS) je z\u00e1kladn\u00ed podm\u00ednkou shody s regulatorn\u00edmi po\u017eadavky pro vstup na v\u011bt\u0161inu sv\u011btov\u00fdch trh\u016f.<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Regulatorn\u00ed podpora v\u00fdvoje<\/a><\/h3>

Cesta k z\u00edsk\u00e1n\u00ed regulatorn\u00edho schv\u00e1len\u00ed pro zdravotnick\u00fd prost\u0159edek je dlouh\u00e1. Av\u0161ak ji\u017e v ran\u00e9 f\u00e1zi p\u0159ed uveden\u00edm na trh, aktivity v oblasti \u0159\u00edzen\u00ed n\u00e1vrhu a v\u00fdvoje (design and development) mus\u00ed b\u00fdt v souladu s platn\u00fdmi regulatorn\u00edmi po\u017eadavky od sam\u00e9ho po\u010d\u00e1tku ka\u017ed\u00e9ho v\u00fdvojov\u00e9ho projektu.<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Regulatorn\u00ed podpora klinick\u00fdch zkou\u0161ek<\/a><\/h3>

Klinick\u00e9 studie a n\u00e1sledn\u00e9 klinick\u00e9 sledov\u00e1n\u00ed jsou nezbytn\u00e9 pro vstup na trh i pro dlouhodob\u00e9 udr\u017een\u00ed z\u00e1konn\u00e9ho schv\u00e1len\u00ed va\u0161eho zdravotnick\u00e9ho prost\u0159edku.<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Audity<\/a><\/h3>

Audity a inspekce jsou nezbytn\u00e9 pro v\u0161echny v\u00fdrobce zdravotnick\u00fdch prost\u0159edk\u016f i jin\u00e9 oborov\u00e9 hospod\u00e1\u0159sk\u00e9 subjekty.<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\u0160kolen\u00ed<\/a><\/h3>

Profesion\u00e1lov\u00e9 v oboru zdravotnick\u00fdch prost\u0159edk\u016f mus\u00ed b\u00fdt schopni porozum\u011bt a spr\u00e1vn\u011b implementovat regulatorn\u00ed po\u017eadavky tak, aby byla dodr\u017eena shoda.\nMeliora Compliance poskytuje \u0161kolen\u00ed v n\u011bkolika oblastech.<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Osoba odpov\u011bdn\u00e1 za dodr\u017eov\u00e1n\u00ed pr\u00e1vn\u00edch p\u0159edpis\u016f (EU MDR)<\/a><\/h3>

Jsme osoba zodpov\u011bdn\u00e1 za dodr\u017eov\u00e1n\u00ed pr\u00e1vn\u00edch p\u0159edpis\u016f.<\/p><\/div><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Dotazy?
\nNapi\u0161te n\u00e1m!<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t<\/i>\t\t\t<\/span>\n\t\t\t\t\t\tKontakt<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Our services We use our broad knowledge and more than 24 years of experience to navigate our clients from the early design and development till device distribution and post-market surveillance activities, with the main focus on the EU and US markets. Our customers are small start-up companies, as well as large established manufacturers and distributors. … \u010c\u00edst d\u00e1l<\/a><\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-89","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/89","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/comments?post=89"}],"version-history":[{"count":170,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/89\/revisions"}],"predecessor-version":[{"id":1504,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/89\/revisions\/1504"}],"wp:attachment":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/media?parent=89"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}