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NIKI PMTA

NIKI PMTA

PMTA (Premarket Itabi risaba) bivuze ko nyuma yitariki ya 15 Gashyantare 2007, urutonde rwemewe n’ibicuruzwa byose by’itabi bisaba kwemerwa na FDA. Ikigo gikeneye gusuzuma niba iki gicuruzwa gifitiye akamaro ubuzima rusange.

Umwihariko wacu

Nyuma yo gutegura umushinga nubushakashatsi, WOOMI yatanze PMTA muri FDA mbere yitariki ya 3 Ukwakira 2021.

Umwihariko wacu

Intambwe ya 1

Itsinda ryumushinga ryashinzwe
Umwihariko wacu

Intambwe ya 2

Ubushakashatsi ku isoko
Umwihariko wacu

Intambwe ya 3

Gutezimbere ibicuruzwa
Umwihariko wacu

Intambwe ya 4

Ikizamini Cyuzuye
Umwihariko wacu

Intambwe ya 5

Gutegura amakuru
Umwihariko wacu

Intambwe ya 6

Tanga gusaba

Kugerageza Ibicuruzwa byacu

Igeragezwa ryibicuruzwa byacu rikora ubushakashatsi nubushakashatsi mu isesengura ryibicuruzwa n’ubushakashatsi bwakozwe, ubushakashatsi butari amavuriro, ubushakashatsi bw’abantu ku buvuzi n’izindi nzego zubahiriza.

Kugerageza Ibicuruzwa byacu
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Ingwate yo Kurinda Ibicuruzwa

Ikizamini cya HPHCs cyateguwe kugirango gisesengure ibice byibicuruzwa mugihe cyimbaraga nyinshi kandi zidafite ingufu nyinshi zikoreshwa, harimo HPHCs nubundi isesengura ry’uburozi, kugirango harebwe imiterere y’uburozi na farumasi y’ibicuruzwa ku buryo burambuye, kugira ngo ibice by’ibicuruzwa bitagira ingaruka, no kurinda umutekano w’abakoresha.
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Ingwate yo Kurinda Umutungo

Muburyo bwo gutoranya abatanga ibicuruzwa no kugenzura ibikoresho fatizo, bisobanure neza PMTA ibisabwa kubisohoka nibisohoka kugirango ibicuruzwa bitangwe kandi byujujwe. Hagati aho, gukurikirana inzira zose ziragerwaho, kandi inshingano za buri murongo zirasobanurwa neza kugirango ibicuruzwa bibe byiza n'umutekano w'ibikoresho fatizo.
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Ingwate yo Kurinda Amashanyarazi

ANSI / CAN / UL 8139, Sisitemu y'amashanyarazi y'itabi rya elegitoroniki n'ibikoresho bya Vaping, byemewe n'ikigo cy'igihugu gishinzwe ubuziranenge muri Amerika (ANSI) hamwe n'Inama ishinzwe ubuziranenge muri Kanada (SCC), ikubiyemo amashanyarazi, gushyushya, bateri no kwishyuza ibyo bicuruzwa. Iterambere rya UL 8139 rikemura kandi ibibazo by’umutekano w’umuriro byagaragajwe n’abashinzwe kuzimya umuriro muri Amerika ya Ruguru.

Uruganda rwa Digital

Tanga ubuziranenge bwisi yose nibicuruzwa bifite umutekano
Uruganda rwa WOOMI rwashyizeho uburyo bwo gucunga ubuziranenge bwa ISO9001: 2015 na GMP820, kandi rushora miriyoni y’amadolari kugira ngo hashyizweho uburyo bunoze bwo gukora inganda n’imicungire y’ubuziranenge, byemeza byimazeyo imiyoborere isanzwe kandi y’ubwenge yo gushushanya no guteza imbere, ibikoresho fatizo by’ibicuruzwa, umusaruro n’inganda, gupima ibicuruzwa, kugenzura ubuziranenge n’ibindi bikorwa, kandi bitanga uburambe ku rwego rw’isi.
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Mes Sisitemu yo Kugenzura Ubwenge

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Inganda-Iyobora Inganda

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Inzira Yuzuye Ikurikiranwa

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Ibikorwa 8 byingenzi byashyizweho kugirango bigenzurwe ubuziranenge, kandi inzira yose irashobora gukurikiranwa binyuze mubuyobozi bwa sisitemu ya MES.
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Kwiyemeza Inshingano Zimibereho

WOOMI yamye ishyira umutekano wibicuruzwa hejuru yurutonde rwayo, kandi yiyemeje gufata inshingano zinganda, abakoresha na societe. Kandi WOOMI yashoye miriyoni z'amadolari yo gutegura PMTA kandi izatanga ibyifuzo bya PMTA muri FDA mbere yitariki ya 3 Ukwakira 2021.

PMTA ntabwo ari inzitizi ku nganda za atomisiyoneri, ahubwo ni intangiriro nshya. WOOMI izakomeza gushyigikira umwuka wo guhanga udushya, ifate inshingano zishinzwe kurinda urubyiruko rukuze, kurengera ubuzima n’umutekano by’abakoresha isi yose, kandi biteze imbere iterambere ryiza kandi ryiza. WOOMI izayobora iterambere ryisoko hamwe nibicuruzwa nikoranabuhanga bishya mubipimo bya PMTA, kandi bizane uburambe bwubuzima kubakoresha isi yose.