Akamaro kaISO 13485Icyemezo kubakora ibikoresho byubuzima gishobora kumvikana kuva murwego rukurikira:
1. Ibyingenzi: Niki?
Icya mbere, ni ngombwa kumva ko ISO 13485 atari igipimo cyibicuruzwa, ahubwo aGucunga ubuziranengeSisitemu (QMS) bisanzwe. Umutwe wacyo wuzuye ni "Ibikoresho byo kwa muganga- Sisitemu yo gucunga neza - Ibisabwa hagamijwe kugenzura. "Ibi bivuze ko byibandauburyo ababikora bashiraho kandi bakabungabunga sisitemukwemeza ko buri ntambwe yo gushushanya, iterambere, umusaruro, kwishyiriraho, no gutanga serivisi igenzurwa, yizewe, kandi yubahiriza amabwiriza.
2. Ibyingenzi Byingenzi Kubakora
1. "Passeport" kumasoko yisi yose
Nibisobanuro byukuri kandi bifatika mubucuruzi. Inzego nyinshi zishinzwe kugenzura isi yose (nka MDR / IVDR y’ubumwe bw’ibihugu by’Uburayi, FDA yo muri Amerika, Ubushinwa NMPA, PMDA y’Ubuyapani) zemera cyangwa zemera ISO 13485 nk’ifatizo ryo kubahiriza amabwiriza.
Umuryango w’ubumwe bw’ibihugu by’i Burayi: Kubahiriza ISO 13485 nuburyo bwibanze bwo kuzuza QMS ibisabwa namabwiriza ya MDR / IVDR.
Amerika: QSR ya FDA (21 CFR Igice cya 820) ihujwe cyane na ISO 13485. Icyemezo cya ISO 13485 cyoroshya cyane inzira yubugenzuzi bwa FDA.
Andi masoko: Ibihugu byinshi, harimo Kanada, Ositaraliya, n’ibihugu byo mu majyepfo y’iburasirazuba bwa Aziya, birasaba cyangwa birasaba cyane ko ababikora bafite icyemezo cya ISO 13485.
Hatariho iki cyemezo, ababikora ntibashobora cyane kugurisha ibicuruzwa byabo kumasoko mpuzamahanga.
2. Kongera umutekano wibicuruzwa ningirakamaro, kugabanya ingaruka
Intego yibanze ya sisitemu ya ISO 13485 ni ukurinda umutekano n’imikorere yibikoresho byubuvuzi. Mugushyira mubikorwa iki gipimo, ababikora bagomba:
Gushiraho uburyo bukomeye bwo kugenzura ibishushanyo: Guhera kubakoresha bakeneye, binyuze mukugenzura no kwemeza, kwemeza ibicuruzwa neza.
Gushyira mu bikorwa gucunga neza ingaruka: Kwinjiza gucunga ibyago mubyiciro byose byubuzima bwibicuruzwa (igishushanyo, umusaruro, post - kugenzura isoko) kugirango utegure kandi ugenzure ingaruka zishobora kubaho.
Menya neza kugenzura inzira: Kuringaniza no kugenzura inzira zose nko kugura, gukora, kugenzura, kubika, no gutwara abantu kugirango ubuziranenge bwa buri cyiciro.
Gushiraho sisitemu yo gukurikirana: Ushobora gukurikirana amateka yose yibicuruzwa kuva kubikoresho fatizo kugeza kumpera - ukoresha, bikwemerera kwibuka byihuse kandi neza niba ibibazo bibaye.
Ibi bigabanya mu buryo butaziguye ibyago byo kwangirika kwabarwayi, ibyabaye mubuvuzi, hamwe ninkiko kubera inenge yibicuruzwa.
3. Kunoza imikorere ikora, kugabanya ibiciro
Nubwo gushiraho sisitemu bisaba ishoramari ryambere, mugihe kirekire, bigabanya cyane ibiciro:
Kugabanya imyanda no kongera gukora: Mugushimangira gukumira aho gukosorwa, gukora ibintu neza ubwambere bigabanya ikiguzi cyibisigazwa, gukora, na nyuma yo - gusana ibicuruzwa.
Ibipimo ngenderwaho: Inzira zisobanutse no kugabana inshingano bigabanya guterana imbere no kwitiranya ibintu, kunoza imikorere.
Amakuru - iterwa no gufata ibyemezo: Sisitemu isaba gusesengura no kunoza bishingiye ku makuru, ifasha abayobozi kumenya impamvu zitera no gufata ibyemezo byiza.
4. Kongera icyizere mubakiriya, abafatanyabikorwa, n'abashoramari
Abakiriya (Ibitaro, Abaganga, abarwayi): Kubona ikimenyetso cyemeza ISO 13485 kibayobora kubona ibicuruzwa byikigo nkibindi byizewe kandi bifite umutekano, byubaka ikizere.
Abaguzi n'ababitanga: Bakenera kenshi ISO 13485 ibyemezo nkibisabwa kugirango babone ibyangombwa.
Abashoramari: Icyemezo cyerekana ko isosiyete ikora neza - icungwa, ifite igenzura rikomeye, kandi ni ishoramari rihamye rifite igihe kirekire -.
5. Urufatiro rukomeye rwo guhangana nubugenzuzi bugenzura
Inganda zikoreshwa mubuvuzi ziragenzurwa cyane. Kugira QMS yumvikana, yemejwe bivuze ko mugihe inzego zishinzwe kugenzura (nka FDA, NMPA) zikora ubugenzuzi butamenyeshejwe cyangwa busanzwe, isosiyete irashobora kwitabira ituje, ikongerera cyane amahirwe yo gutsinda ubugenzuzi no kwirinda ingaruka zikomeye nko guhagarika ibicuruzwa, ihazabu, ndetse no guhagarika isoko kubera kutubahiriza -.
6. Gutwara Umuco wo Gukomeza Gutezimbere
ISO 13485 isaba ibigo gushingaIgikorwa cyo gukosora no gukumira (CAPA)inzira hamwe nuburyo bwo gusuzuma. Ibi bihatira isosiyete kutaruhuka ahubwo ishakisha byimazeyo ibibazo, gusesengura ibitera, no gufata ingamba zo gukumira ko bitazongera kubaho, bityo bikagira urwego rwiza rwo kwikorera - gutera imbere no gukomeza gutera imbere.
7. Icyitonderwa kidasanzwe: Gutandukanya ibikoresho byubuzima nibikoresho byubuvuzi
Ingingo y'ingenzi ikeneye gushimangirwa:Ntabwo "ibikoresho byubuzima" byose ari "ibikoresho byubuvuzi."
Ibikoresho byo kwa muganga: Igamije gusuzuma, gukumira, gukurikirana, kuvura, cyangwa kugabanya indwara, nibindi, bifite intego isobanutse yubuvuzi. Amabwiriza yabo arakomeye, kandi bomubisanzwekubahiriza ISO 13485 n'amabwiriza ajyanye nayo.
Ibikoresho byubuzima / Ubuzima bwiza: Ahanini ikoreshwa mubuyobozi bwubuzima, ubuzima bwiza, kuzamura imibereho, nibindi, kubantu muri rusange bafite ubuzima bwiza (urugero, ibisanzwe bisanzwe byubwenge, umunzani wibiro, massage). Amabwiriza yabo aroroshye.
Ariko, inzira irahinduka:
Imipaka itagaragara: Ibikoresho byinshi byubuzima bwabaguzi bavuga ko ibikorwa bigenda byegereza ubuvuzi (urugero, gukurikirana ECG, umuvuduko wamaraso), ibyo bikaba bishobora gutuma bahindurwa nkibikoresho byubuvuzi.
Kurera abana: Nubwo bitashyizwe mubikorwa nkibikoresho byubuvuzi, benshi imbere - batekereza ko abakora ibikoresho byubuzima batekereza bashishikaye gukoresha ISO 13485 kuko:
Kwitegura ejo hazaza: Gutegura ibisabwa byateganijwe bituruka ku kuzamura ibicuruzwa cyangwa kwagura ibintu.
Kugaragaza Ubwitange Bwiza: Ku isoko rihiganwa, gukoresha ibipimo bihanitse kugirango ugaragaze ko biyemeje ubuziranenge n'umutekano bitera inyungu zitandukanye.
Guhura Ibisabwa Byinshi - Kurangiza abakiriya: Ibitaro bimwe cyangwa ibigo byumwuga birashobora gusaba abafatanyabikorwa babo kugira sisitemu yo gucunga neza.
Incamake
Ku bakora ibikoresho byubuzima,akamaro k'icyemezo cya ISO 13485 gishobora kuvugwa muri make nka:
Ubucuruzi, niurufunguzo rwa zahabuku masoko y'isi.
Uhereye kubicuruzwa, nimoatkubungabunga umutekano no gukora neza.
Uhereye kubuyobozi, nioptimizeryo kunoza imikorere no kugabanya ibiciro.
Ingamba, niimfurukayo kubaka ikizere no kugera ku majyambere arambye.
Kubwibyo, haba mubakora ibikoresho byubuvuzi byasobanuwe byemewe n'amategeko cyangwa kubigo byiyemeje gucengera cyane mubuzima no kubaka ikirango cyiza, gushora imari no kubona icyemezo cya ISO 13485 nicyemezo cyibikorwa bifite agaciro gakomeye cyane.
Kuberiki Hitamo Ultrasonic Isukura Kubucuruzi bwawe?
· OEM / ODM Yiteguye:Inkunga yo gucapa ibirango, gutunganya amabara, no gushushanya.
· Agaciro keza ku isoko:Ihuza ultrasonic isuku hamwe na UV yangiza mugikoresho kimwe.
Kugenzura ubuziranenge buhamye:Buri gice cyageragejwe kuri ultrasonic frequency, ubukana bwa UV, nigihe kirekire.
· Abaguzi bakeneye cyane:Kongera kwibanda ku isuku yumuntu no korohereza ibinyabiziga gusubiramo.
Kubungabunga bike:Birebire - ibice biramba nibikorwa bikora bigabanya garanti.
Ibyiza by'ingenzi
1. Ikorana buhanga rya tekinoloji kugirango ikorwe neza
US100 Ultrasonic IsukuraKwishyira hamweultrasonic vibration (>42.000Hz)hamwe naUV - C urumuri, gutanga 2 - byuzuye muri - 1 mugikorwa cyo gusukura no kwanduza. Imiraba ya ultrasonic itanga mikorobe isenyuka ikanakuraho ibisigazwa byinangiye, mugihe urumuri UV-C rukuraho 99,99% ya bagiteri na virusi-bigatuma isuku yimbitse, itekanye idafite imiti.
2. UV enye - C Itara rya dogere 360 Byose - Kuzunguruka
Bifite ibikoreshobine UV - C amasaro yoroheje, iki gikoresho kigera ku cyumba cyose cyogusukura. Igishushanyo mbonera cya sterilisation yerekana ibintu byose hejuru yikintu - yaba ibikoresho by amenyo cyangwa imitako - yanduye kimwe, byongera isuku nicyizere cyabakoresha.
3. 42 kHz Hejuru - Imbaraga za Ultrasonic
Gukorera hejuru42.000Hz, US100 itanga ibisobanuro byuzuye, hejuru - imbaraga zamazi zishobora gukuraho imyanda ya microscopique ndetse no mu cyuho gikomeye. Ibi bituma biba byiza mugusukura ahantu nkibintu byiza byimitako, ibinono by amenyo, hamwe nu mwanya uri hagati yo guhuza amenyo.
4. Automatic 5-Minute Isuku Cycle
UwitekaImikorere ya UV - C ihita ifunga nyuma yiminota 5, gukumira gukabya no kubungabunga imbaraga. Iyi mikorere yigihe cyubwenge itanga ibisubizo bihamye, imikorere yoroshye, numutekano kubakoresha nibintu bisukurwa.
5. Multi - Ubushobozi bwo Gusukura
Iki gice kibereye kumurongo mugari wa porogaramu, bigatuma kongerwaho agaciro kumurongo uwo ariwo wose wibicuruzwa:
Isuku yo mu kanwa:Amenyo, abayagumana, imitwe yoza amenyo, hamwe nabashinzwe kurinda amenyo.
Imitako:Impeta, urunigi, ibikomo, impeta, na diyama.
Ibintu bya buri munsi:Amasaha adafite amazi, amasaha yo kureba, ibiceri, ibikoresho byuma, nibikoresho bito.
6. Kuramba no Gukoresha {{1} Design Igishushanyo mbonera
Yubatswe hamwe nibikoresho byiza - nibikoresho byiza hamwe numubiri woroshye, wuzuye, iki gikoresho nicyiza kandi gifatika. Byoroheje kimwe - imikorere ya buto na cycle ikora bituma biba byiza gukoreshwa burimunsi murugo, mumavuriro y amenyo, cyangwa mugihe cyurugendo.
Ibicuruzwa byinshi
HuizhouZahabuIkoranabuhanga Co,. Ltd yashinzwe mu 2017, ihuza R&D, gukora no kugurisha ibicuruzwa byita ku rugo nk'imfashanyigisho zumva, isuku ya CPAP n'ibindi. Twishimiye itsinda ryinzobere kandi ryitanze rifite ubuhanga burenze imyaka icumi mubuhanga bwa elegitoroniki nubuvuzi bujyanye nubuzima. Abashinze baturuka ku isi - ibigo bizwi nka TCL na Alibaba. Bakoreye muri SONY, Harman, Philips, LG no mubindi bigo. Itsinda ryacu R&D ririmo abashushanya indangamuntu, injeniyeri za software, injeniyeri za elegitoronike, injeniyeri zubukanishi, injeniyeri nziza, injeniyeri zububiko nibindi. Yiyeguriye kugenzura ubuziranenge no gutanga serivisi nziza kubakiriya, inararibonye zacu zirahari burigihe kugirango tuganire kubyo usabwa kandi tumenye neza ko abakiriya banyuzwe. Twongeyeho, twageze kuri FDA, CE, FCC, RoHS, SGS na PSE . 107 uburenganzira hamwe nuburenganzira bwumutungo wubwenge kubintu byavumbuwe. Gutunga ibirango, ibirango na patenti mubushinwa, Amerika, Uburayi n'Ubuyapani. Twishimiye kandi amabwiriza ya OEM na ODM. Tuzashiraho tubikuye ku mutima kandi dusangire intsinzi nabakiriya bose. Murakaza neza kutwandikira kubindi bisobanuro kandi dutegereje gukorana nawe.
Shaka ibicuruzwa
Ohereza iperereza kugirango ubone ibiciro byibicuruzwa bigezweho.
1. Igihe cyo gutanga icyitegererezo: Ingero zoherejwe muminsi 1-3.
2. Igihe cyo gutanga ibicuruzwa: Ibicuruzwa bizoherezwa muminsi 15-35. Itariki yo koherezwa izagenwa hashingiwe ku bwinshi no kugereranya ibicuruzwa.
MO MOQ nto. Kuvanga amabara biremewe. Amazone ya FBA hamwe na serivise yambere yubwato. Shyigikira abadandaza bato n'abaciriritse, itsinda rinini na rito rivanze icyiciro, igiciro cyiza, Gutanga OEM, urashobora guhitamo LOGO, gupakira, kode yumurongo, agasanduku, amakuru yose yoherejwe -.
Turashobora gutanga uburyo ubwo aribwo bwose bwubucuruzi, harimo EXW, FOB, CIF, DDU (ibicuruzwa byemewe byinjira kumuryango udafite imisoro) na DDP (ibicuruzwa byemewe byinjira kumuryango no gutanga imisoro) kandi tugafasha abaguzi benshi guhitamo inzira nziza yo kohereza kugirango ubike igihe n'amafaranga.
OEM / ODM
Twumva neza ibyifuzo byibanze byabakiriya bisi murwego rwa OEM / ODM yihariye. Gukoresha imyaka yo muri - ubuhanga bwo gutanga ubumenyi bwimbitse hamwe nuburambe bwibikorwa bya digitale, serivisi zacu bwite zo kwihererana zubatse inyungu zinyuranye mubice bitanu byingenzi, zitanga ibisubizo byoroshye kandi byiza kubakiriya bafite umunzani n'ibikenewe:
LOGO - Guhindura ibirango byihariye LOGO.
Gupakira - Tanga ibisubizo byabugenewe.
HANZE - Guhindura ibicuruzwa nibicuruzwa
Mugihe dukurikirana umunezero wumubiri numwuka mubakozi bose, dutanga byoroshye - kugeza - gukoresha kandi byoroshye ibicuruzwa byita kumurugo, bituma buri muryango urinda ubuzima bwabo byoroshye kandi bikagira uruhare mubuzima bwabantu nibyishimo.
1.20'IMYAKA Yuburambe bw'abatanga isoko
2.Umwe - guhagarika Serivisi
Kugenzura 3.100% mbere yo koherezwa
4. Umukungugu - ipantaro ya Purifcaton yubusa
uruganda rwacu
Urugandaiherereye mu mujyi wa Huizhou, Intara ya Guangdong, mu Bushinwa, ifite ubuso bwa metero kare 10,000. Ifite itsinda rinini rya R&D rigizwe nabashushanyije indangamuntu, injeniyeri za software, injeniyeri za elegitoronike, injeniyeri zubukanishi, abahanga mu buhanga, abahanga mu gukora imashini, n'ibindi.
Mugenzi wacu
100+ ikirango cyizewe
Impamyabumenyi
SGS
FC
CE
FDA
RoHS
gusuzuma abakiriya
