Kohereza ibicuruzwa bisukura uruganda, bigatsinda ubugenzuzi, bikagera aho bijya - gusa bigomba gukorerwa kuri gasutamo kuko icyemezo kimwe kidahuye nibisabwa byaho. Kubirango nababikwirakwiza biva mubuvuzi mubushinwa, ibi ntabwo ari hypothetical. Nibimwe mubisanzwe - kandi bihenze - gushakisha amakosa mubucuruzi bwibikoresho byubuvuzi byambukiranya imipaka.
Byinshi muribi bibazo biva ku cyemezo kimwe: guhitamo uwaguhaye isoko utagenzuye neza ibyemezo byayo, sisitemu nziza, nubushobozi bwo gukorera amasoko yawe yihariye. Iyi ngingo iragabanya ibyo kugenzura, impamvu bifite akamaro mubucuruzi, nuburyo uruganda rwashizweho nka Joytech Healthcare rukemura buri kimwe mubisabwa.
Ninde Muguzi Ibi Byingenzi Kuri Imigabane isa itandukanye bitewe nuwashakishije - ariko ibikenewe ni bimwe.
• Abatanga ibicuruzwa bitumizwa mu masoko yagenwe bakeneye ibyemezo bihuye n’amategeko agenga aho bijya - kudahuza birashobora guhagarika ibicuruzwa byose kuri gasutamo.
• Abafite ibicuruzwa birinda ishusho yikirango bakeneye uwabikoze afite sisitemu yubuziranenge bashobora kwizera - kuko ni izina rya nyir'ibicuruzwa ku bicuruzwa, ntabwo ari ibyakozwe. Ibibazo byiza bigera kumukoresha wa nyuma bikunda gutekereza kubirango, ntabwo biri muruganda ruri inyuma.
• Abaguzi ba OEM / ODM batanga gahunda yihariye bakeneye umufatanyabikorwa ushobora gukomeza ingano ninyandiko mumibanire yimyaka myinshi, ntabwo ikora rimwe gusa.
Ibyingenzi bitandukanye, ariko nibyiza byose bitangirira kumwanya umwe: genzura ubushobozi bwabatanga mbere yo gukora.
Kuki ibyangombwa bitanga isoko bihitamo isoko ryawe Mbere yigiciro cyangwa kuyobora igihe, wemeze niba ibyangombwa byuwabikoze bifashe koko. Inzira igikoresho igana kuri buri soko biterwa nimpamyabumenyi zidahita zihererekanya - ikuraho akarere kamwe gashobora gukenera isuzuma ritandukanye mukindi. Ibipimo bitatu bifite akamaro kanini, kandi buri kimwe gishobora guhindura umurongo wawe wo hasi:
• Ubwiza bwibicuruzwa bihoraho - bifasha kurinda imipaka no kugabanya inyungu. Uruganda rukora muri sisitemu yo gucunga neza nka ISO 13485 igenzura imikorere yayo kurwego rwisosiyete, bityo umusaruro ugakomeza guhanurwa mubikorwa byose. Kubaguzi, ibyo birashobora gufasha kugabanya ibice bifite inenge bigera kubakiriya ba nyuma, ibiciro byo kurega, no kugabanya inyungu yatakaye.
• Isoko ryinshi ryiteguye - inzira nyinshi zinjiza, igihe cyihuse cyo kubika. Impamyabumenyi yihariye ku isoko igena aho ibicuruzwa byawe bishobora kugurishwa byemewe n'amategeko. Icyemezo cya CE MDR gishyigikira kugera ku isoko ry’iburayi, mu gihe FDA 510 (k) yemewe (ku ngero zikoreshwa) ishyigikira kugera ku isoko ry’Amerika. MDSAP itanga urwego rumwe rwubugenzuzi rwemewe ninzego zibishinzwe mu nkiko eshanu, zifasha ababikora gukora neza imicungire yubuziranenge ku masoko menshi. Hatariho ibyemezo byemewe kandi byemewe, kuzana ibicuruzwa kumasoko birashobora gutinda.
• Isoko ryizewe - rifasha kubika ububiko hamwe nabakiriya bagaruka. Uruganda rufite ubushobozi bwo gukora, ipatanti, hamwe nubujyakuzimu bwubwubatsi kugirango butange imyaka myinshi - ntibuzuza gusa itegeko rimwe - irashobora gushyigikira ibihe byateganijwe mbere yo kuyobora, gufasha kugabanya ububiko, no guha ubucuruzi bwawe umwanya munini wo gukura.
Nigute Ubuvuzi bwa Joytech bushigikira abaguzi bambuka imipaka Ubuvuzi bwa Joytech bwatangiye gukora ibikoresho byubuvuzi kuva 2002 none byoherezwa mu bihugu birenga 150. Ibicuruzwa byayo bikubiyemo ibipimo byerekana umuvuduko wamaraso, pompe yamabere, compressor nebulizers, oximeter yintoki, hamwe na termometero yubuvuzi. Kubaguzi bashakira ibikoresho byubuvuzi biva mubushinwa, bivuze ko utanga isoko ahagaze kugirango akore ibyangombwa, ibyemezo, hamwe nibikorwa bihoraho ubucuruzi bwamasoko menshi busaba.
• Ashobora gufasha kugabanya inyungu no kurinda izina - Joytech ikorera muri sisitemu yo gucunga neza ISO 13485 kurwego rwisosiyete. Abaguzi barashobora gusaba no kugenzura iyi nyandiko mu buryo butaziguye, bakemeza ko icyiciro kimwe kugeza mbere mbere yo gukora.
• Bishyigikiwe no gushyigikira isoko mu turere twinshi - Imirongo y’ibicuruzwa ya Joytech itwara CE MDR ku isoko ry’Uburayi, FDA 510 (k) yemewe ku ngero zatoranijwe muri Amerika, hamwe n’icyemezo cya MDSAP gikubiyemo inkiko eshanu zigenga. Abaguzi barashobora kwemeza ubwishingizi kubicuruzwa n'uturere bateganya gukorera.
• Yubatswe kugirango ishyigikire ubufatanye bwigihe kirekire - Hamwe na metero kare 260.000 zubushobozi bwumusaruro, patenti zirenga 100, hamwe nitsinda ryubushakashatsi ryinzobere zirenga 100, Joytech ashyigikira gahunda yimyaka myinshi - guha abafatanyabikorwa kugera mubyiciro byinshi binyuze mumasoko abishoboye.
Ibyo Joytech akora Ibicuruzwa byita ku buzima bya Joytech bikubiyemo ibyiciro bitanu byingenzi byubuvuzi:
• Ikurikiranabikorwa ryumuvuduko wamaraso
• Amaberebere - amabere yambara, amashanyarazi, nintoki. Ultra-ituje ikora muburyo bwingenzi yateguwe kugirango ifashe kugabanya ibibazo byanyuma-ukoresha no kugaruka.
• Compressor nebulizers - ibishushanyo byabantu bakuru kandi bifasha abana, bifasha abaguzi gutanga serivisi nini kubakiriya hamwe na SKU nkeya.
• Oximeter ya Fingertip pulse - Iboneza rya Bluetooth hamwe na Bluetooth SKU iboneza kugirango imiyoboro ihagaze neza.
• Ivuriro rya termometero - ibintu byinshi muburyo butandukanye bwabana, abakuze, nimiryango yose ihagaze, biha abaguzi guhinduka kugirango bubake ibicuruzwa byinshi biva mubitanga.
Imirongo yose yibicuruzwa irahari kuri OEM, ODM, hamwe nubufatanye-bwihariye.
Twiteguye gushakira hamwe natwe? Waba uri umugabuzi, nyir'ibicuruzwa, cyangwa umuguzi wa OEM / ODM, umufatanyabikorwa mwiza wo gukora arashobora gufasha koroshya kubahiriza, kurinda ikirango cyawe, no gushyigikira iterambere ryawe ku masoko. Kugirango utangire hamwe na Joytech Healthcare, wegera kuri sale14@sejoy.com . Abaguzi barashobora gusaba:
• Icyemezo cya ISO 13485 hamwe na sisitemu yubuziranenge
• CE MDR na FDA 510 (k) imiterere yimiterere yibicuruzwa byakoreshwa
• Icyemezo cya MDSAP ibisobanuro birambuye hamwe nububasha
• Ibicuruzwa byihariye, MOQ, na OEM / ODM uburyo bwo guhitamo
• Gahunda yo kugenzura uruganda cyangwa ingendo shuri
Ibibazo Ni izihe mpamyabumenyi abaguzi bagomba kugenzura mugihe bakuye ibikoresho byubuvuzi biva mubushinwa? Ibyangombwa by'ingenzi birimo ISO 13485 (urwego rwo mu rwego rwo gucunga ubuziranenge ku rwego rw'isosiyete), CE MDR (urwego rw'ibicuruzwa, ku isoko ry’iburayi), kwemeza FDA 510 (k) (urwego rw'icyitegererezo, kuri Amerika, rukubiyemo ibicuruzwa byatoranijwe), na MDSAP (urwego rumwe rw'ubugenzuzi rwemewe mu nkiko eshanu). Buri kimwe gikora intego zinyuranye zo kugenzura, abaguzi rero bagomba kwemeza ubwishingizi kubicuruzwa byabo byihariye.
Icyemezo kimwe gikubiyemo amasoko yose yohereza hanze? Oya. Kwemeza kugenzura ni isoko- kandi akenshi ni moderi yihariye. Icyemezo cyemewe mukarere kamwe ntabwo gihita cyemerera kugurisha mukindi. Ibikorwa nka MDSAP birashobora gufasha guhuza amasoko menshi, ariko abaguzi bagomba kugenzura buri soko ryigenga ryigenga.
Nigute gushakira ibicuruzwa byashizweho bigabanya ingaruka? Utanga ibicuruzwa bifite sisitemu yubuziranenge igenzurwa, ibyemezo byamasoko yagutse, hamwe nubushobozi buhoraho bwumusaruro arashobora gufasha abaguzi kwirinda kubahiriza ibyakozwe, gutinda kubyoherezwa, nimbogamizi zinjira kumasoko - kugabanya ibiciro hamwe ningaruka ziterwa numubano wamasoko.
