Iqoqo Legazi Lokuphepha Kwedivayisi Yezokwelapha Setha i-FDA CE ISO
Isethi yokuqoqwa kwegazi, eyaziwa nangokuthi inaliti yovemvane, iyithuluzi lezokwelapha elisetshenziselwa ukuthola amasampula egazi ukuze lihlolwe noma kunikelwe. Idizayinelwe ukuxhuma kushubhu yevacuum noma isirinji ukuze kuqoqwe igazi. Isethi ngokuvamile iqukethe inaliti emfushane, ishubhu eguquguqukayo, futhi ngezinye izikhathi idivayisi yokuphepha yokuvala inaliti ngemva kokusetshenziswa. Ivamise ukusetshenziswa kuzilungiselelo zomtholampilo ezifana nezibhedlela, amalabhorethri, nezikhungo zokunikela ngegazi. Inalithi yovemvane iwusizo ikakhulukazi lapho ufinyelela emithanjeni okunzima ukuyifinyelela, njengaleyo esezandleni noma imithambo emincane ezinganeni.
Izici Nezinzuzo
CE
ISO13485
I-USA FDA 510K
I-TS EN ISO 13485: 2016/AC:2016 Uhlelo lokuphatha ikhwalithi yempahla yezokwelapha ngezidingo zokulawula
I-TS EN ISO 14971 Amadivayisi wezokwelapha ka-2012 - Ukusetshenziswa kokulawulwa kobungozi emishinini yezokwelapha
I-ISO 11135:2014 Idivaysi yezokwelapha Ukuvalwa inzalo kwe-ethylene oxide Ukuqinisekisa nokulawula okujwayelekile
I-ISO 6009:2016 Izinaliti zomjovo oyinyumba ezilahlwayo Thola ikhodi yombala
I-ISO 7864: 2016 Izinaliti zomjovo oyinyumba ezilahlwayo
I-ISO 9626:2016 Amashubhu enaliti ensimbi engagqwali okwakhiwa kwemishini yezokwelapha
I-SHANGHAI TEAMSTAND CORPORATION ingumhlinzeki oholayo wemikhiqizo yezokwelapha nezisombululo.
Ngaphezulu kweminyaka eyi-10 yokuhlangenwe nakho kokuhlinzekwa kokunakekelwa kwezempilo, sinikezela ngokukhethwa komkhiqizo okubanzi, amanani ancintisanayo, izinsizakalo ze-OEM ezihlukile, kanye nokulethwa okuthembekile ngesikhathi. Sibe ngabahlinzeki boMnyango Wezempilo Kahulumeni Wase-Australia (AGDH) kanye Nomnyango Wezempilo Yomphakathi wase-California (CDPH). E-China, sikleliswe phakathi kwabahlinzeki abaphezulu boMjovo, Umjovo, Ukufinyelela Kwemithambo, Izisetshenziswa Zokuvuselela, I-Hemodialysis, Inalithi Ye-Biopsy kanye nemikhiqizo ye-Paracentesis.
Ngo-2023, sase silethe ngempumelelo imikhiqizo kumakhasimende emazweni angu-120+, okuhlanganisa i-USA, EU, Middle East, kanye neSoutheast Asia. Izenzo zethu zansuku zonke zibonisa ukuzinikela kwethu kanye nokusabela kwethu ezidingweni zamakhasimende, kusenza sibe umlingani webhizinisi othembekile nodidiyelwe okhethwayo.
Sizuze idumela elihle phakathi kwawo wonke lawa makhasimende ngenkonzo enhle kanye nentengo yokuncintisana.
I-A1: Sinesipiliyoni seminyaka eyi-10 kulo mkhakha, Inkampani yethu ineqembu lochwepheshe kanye nomugqa wokukhiqiza oqeqeshiwe.
A2. Imikhiqizo yethu enekhwalithi ephezulu kanye nentengo yokuncintisana.
I-A3.Ngokujwayelekile i-10000pcs; singathanda ukubambisana nawe, akukho ukukhathazeka mayelana ne-MOQ, vele usithumelele ukuthi yiziphi izinto ofuna uku-oda.
A4.Yebo, ukwenza ngokwezifiso Ilogo kwamukelwe.
I-A5: Imvamisa sigcina iningi lemikhiqizo esitokweni, singathumela amasampula ngezinsuku zokusebenza ezingama-5-10.
I-A6: Sithumela nge-FEDEX.UPS, DHL, EMS noma uLwandle.
IInalithi Yevemvane Ehlehlayoungumguquliidivayisi yokuqoqa igaziehlanganisa ukusebenziseka kalula nokuphepha kwe-ainaliti butterflyngesivikelo esengeziwe senaliti ehoxayo. Lolu hlelo olusha lusetshenziselwa ukuqoqa amasampula egazi ezigulini ukuze kuhlolwe futhi kusetshenziswe izinqubo ezihlukahlukene zezokwelapha. Inaliti yovemvane ehoxayo ifakwe indlela yasentwasahlobo evumela inaliti ukuthi ibuyele endlini ngemva kokusetshenziswa, inciphisa ingozi yokulimala kwezinaliti. Idivayisi inenzuzo ikakhulukazi kochwepheshe bezempilo abavamise ukuphatha izinqubo zokuqoqa igazi, njengoba inciphisa ubungozi bezinti zenaliti ngephutha.
