ISO 13485 Certification ewa amaanyi abakola ebyuma by'ebyobulamu, ekkolero lya China lifuna obwesige mu nsi yonna n'amaanyi

Nga omukozi w’Abachina ow’enjawulo mu bitundu bya Ultrasonic ne Hearing Aid, ebikakasibwa n’enkola ya ISO 13485 Medical Device Quality Management System, tukimanyi bulungi nti satifikeeti eno esinga wala ekiwandiiko. Ye jjinja ery’oku nsonda eri abakola ebyuma by’ebyobulamu okufuna obutale bw’ensi yonna n’okuzimba omutindo ogw’enjawulo, nga kirimu okwewaayo okw’amaanyi eri obukuumi bw’abalwadde n’obulungi bw’obujjanjabi.

Okusinziira ku mbeera y’ebiragiro by’ebyuma eby’obujjanjabi eby’ensi yonna ebigenda byeyongera, omutindo gwa ISO 13485 gufuuse omutindo gw’amakolero ogumanyiddwa ennyo. Ku bakola ebyuma by’ebyobulamu, okufuna satifikeeti eno kitegeeza okuteekawo enkola ya ssaayansi, ey’omutindo, era erongoosa obutasalako ey’okuddukanya omutindo. Enkola eno ebuna buli mutendera: okuva ku nteekateeka y’ebintu n’okukulaakulanya, okugula ebintu ebisookerwako, n’okukola, okutuuka ku kwekenneenya n’okugezesa, okutereka, okutambuza, n’okumala-empeereza y’okutunda. Kikakasa nti buli kyuma ekikebera amaloboozi (ultrasonic diagnostic device) ne buli kimu ekiyamba okuwulira nga kiva ku layini yaffe ey’okufulumya kirina obutakyukakyuka n’okulondoola mu bulamu bwakyo n’obulungi bwakyo.

Okusingira ddala, obukulu obukulu obw’okuweebwa satifikeeti ya ISO 13485 eri abakola ebintu buli mu:

Okwongera ku bulungibwansi bw’okuddukanya omutindo: Kivuga amakampuni okuteekawo obuwangwa obw’omutindo nga essira liteekeddwa ku kuziyiza n’okwetaba mu bujjuvu. Okuyita mu nkola entegeke okufuga n’okuddukanya akabi, kikendeeza nnyo ku miwendo gy’ebintu ebirina obuzibu n’obulabe bw’okujjukira akatale, okukuuma obukuumi bw’omulwadde n’abakozesa.

Okunyweza akatale k’ensi yonna: Okuweebwa satifikeeti eno kyetaagisa oba kikulu nnyo mu kuyingira mu butale bw’ensi yonna obukulu bungi, gamba ng’omukago gwa Bulaaya, Canada, ne Japan. Era kikwatagana bulungi ne FDA's QSR 820. Ekola nga "Passport," okwanguyiza ennyo enkola z'okuwandiisa n'okukkiriza ebintu mu butale bw'ensi yonna.

Okuwangula obwesige bwa kasitoma n’omukwano: Ku malwaliro, obulwaliro, abagaba, n’enkomerero-abakozesa, okulonda ebintu ebirina satifikeeti ya ISO 13485 kitegeeza okulonda okwesigamizibwa n’obukugu. Kino kizimba obwesige obw’akatale obunywevu eri omukozi, okufuuka eky’obugagga ekikulu eky’okufuna enkolagana ey’ekiseera ekiwanvu-.

Okuvuga obuyiiya bwa tekinologiya n’okulongoosa ebintu: Enkola eno yeetaaga okufuga ennyo n’okuwandiika ebikwata ku nkola y’okukola dizayini n’okukulaakulanya. Kino kiwaliriza amakampuni okuteeka emisingi egy’omutindo ogwa waggulu-okuva ku ntandikwa yennyini ya R&D, okutumbula obuyiiya bwa tekinologiya obukakali era obulungi obutuukana n’ebyetaago by’obujjanjabi n’abakozesa.

Nga ekkolero ly’Abachina erikakasibwa ISO 13485, bulijjo enzirukanya y’omutindo tugitwala ng’obulamu bwaffe. Tukkiriza nnyo nti okunywerera ennyo ku mutindo gw’ensi yonna si nkola ya kuvuganya kwa katale kwokka, wabula buvunaanyizibwa bwa musingi bwe tutwala ng’abakola ebyuma eby’obujjanjabi. Nga tugenda mu maaso, tujja kwongera okukozesa enkola eno ennywevu ey’okuddukanya okusobola okulongoosa enkola z’okufulumya buli kiseera n’okutumbula omulimu gw’ebintu. Tuli beetegefu okuwa eby’okugonjoola ebizibu eby’amaanyi era ebyesigika eby’amaloboozi amangi n’okuwulira, okuweereza ekibiina ky’ebyobulamu mu nsi yonna, n’okuyamba amaanyi g’ebintu eby’Abachina mu kulongoosa obulamu bw’abantu.

Ebitukwatako .

Huizhou Golden Rose Technology Co., Ltd. ye kkampuni ekola ebbaluwa ya ISO 13485 era nga ye mukwaano ogwesigika mu kkampuni ezimanyiddwa ennyo mu nsi yonna. Emirimu gyaffe gikwatagana n’omutindo gw’ensi yonna ogw’amaanyi, okukakasa omutindo ogukwatagana n’okwesigamizibwa. Nga twewaanira ku busobozi bw’okufulumya buli lunaku yuniti 20,000, twewaddeyo okuwagira enkulaakulana ya bannaffe. Tunoonya nnyo okukola enkolagana ey’olubeerera n’okunoonyereza ku mikisa emipya egy’enkulaakulana ey’okukolagana.

Weereza ekibuuzo okufuna emiwendo gy'ebintu ebisembyeyo.

1. Ekiseera ky’okutuusa sampuli: Sampuli zijja kusindikibwa mu nnaku 1-3.
2. Ekiseera ky’okutuusa ebintu: Ebintu bijja kusindikibwa mu nnaku 15-35. Olunaku lw’okusindika lujja kusalibwawo okusinziira ku buzibu n’obungi bw’okulongoosa.

【Low moq limited. Langi z’okutabula zikkirizibwa. Amazon FBA Okuwandiika n'okuweereza emmeeri esooka.Support entono n'eza wakati, ennene n'entono batch mixed batch, price ensaamusaamu,okuwa OEM, esobola okulongoosa logo, okupakinga, stick bar code, box mark, byonna pre-amawulire.】

Tusobola okuwaayo ekika kyonna eky'ebisanja by'obusuubuzi, omuli Exw,Fob,Cif,DDDU(Custom clearance door to door service without taxes) ne DDP(Custom clearance door to door service with taxes) era n'okuyamba abaguzi mu bungi okulonda engeri esinga okusaanira okusindikamu obudde bwo ne ssente zo.

 

OEM/ODM .

 

 

Tutegeera bulungi ebyetaago ebikulu ebya bakasitoma b’ensi yonna mu kitundu kya OEM/ODM customization. Nga tukozesa emyaka gya mu-Obukugu obw’amaanyi mu nkola y’okugaba n’obumanyirivu mu nkola ya digito, empeereza zaffe ez’obwannannyini ez’okulongoosa zizimbye enkizo ez’enjawulo mu bitundu bitaano ebikulu, nga ziwa eby’okugonjoola ebikyukakyuka era ebikola obulungi eri bakasitoma ab’emitendera egy’enjawulo n’ebyetaago:

 

logo-Eky'akabonero akalaga nti kaliko akabonero ak'enjawulo.

 

Okupakinga-Okuwa eby’okugonjoola eby’okukola dizayini ebikoleddwa ku mutindo.

 

Ebweru-Embala z'ebintu ezisobola okulongoosebwa n'omusono .

 

Nga tugoberera essanyu ery’ebintu n’eby’omwoyo ery’abakozi bonna, tuwa ebyangu-okuyimusa-ebintu ebikozesebwa mu bulamu bw’awaka era ebinyangu, okusobozesa buli maka okukuuma amangu obulamu bwabwe n’okuyamba ku bulamu bw’abantu n’essanyu.

 

1.20'years of supplier obumanyirivu .
2.One-Okukomya .
3.100% okwekebejja nga tebannaba kusindika .
4.Enfuufu-Empale ya Purifcaton ey'obwereere .

 

 

ekkolero lyaffe .

 

Ekkolero .Kisangibwa mu kibuga Huizhou, mu ssaza ly’e Guangdong mu China, nga kiweza square mita ezisukka mu 10,000. Eriko ttiimu ennene eya R&D erimu abakola endagamuntu, bayinginiya ba pulogulaamu, bayinginiya ab’amasannyalaze, bayinginiya b’ebyuma, bayinginiya ab’omutindo, bayinginiya b’ebibumbe, n’ebirala nga balina obumanyirivu obw’emyaka 15 obw’okwewaayo mu R&D, ekkolero lino likolagana n’ebika ebikulu nga Sony, Harman, Philips, ne LG, obumanyirivu bw’okukolagana ne pulojekiti obw’obugagga obukung’aanyizza.

Munnaffe .

 

100+ Brand eyesigika okulonda .

 

Twenyumiriza mu kukolagana n'ensi yonna-Ebika ebimanyiddwa ennyo n'emikutu gy'ebyamaguzi egy'ensi yonna, omuli Amazon, Walmart, Tesco, Costco, eBay, Lazada, Wish, Philips, Sony, ne Toshiba. Okuyita mu nkolagana zino, ebintu byaffe bituuka ku bukadde n’obukadde bw’abaguzi mu nsi yonna, ne bafuna obwesige n’okusiimibwa olw’omutindo n’obuyiiya.

 

 

certifications zaffe .

 

 

SGS .

FC .

CE .

FDA .

Rohs .

 

 

Okwekenenya kasitoma .