Amakulu g’ISO 13485 .Okukakasa abakola ebyuma by’ebyobulamu kuyinza okutegeerwa okuva ku mitendera gino wammanga:
1. Core Essence: Kiki?
Ekisooka, kikulu nnyo okutegeera nti ISO 13485 si mutindo gwa bikozesebwa, wabulaEnzirukanya y’omutindo .Enkola (QMS) Omutindo .. Omutwe gwayo mu bujjuvu guli " .Ebyuma ebikozesebwa mu by'obujjanjabi .- Enkola z'okuddukanya omutindo - Ebyetaago olw'ebigendererwa by'okulungamya." Kino kitegeeza nti essira liteekebwa kuEngeri abakola ebintu gye bateekawo n'okulabirira enkola .Okukakasa nti buli mutendera gwa dizayini, okukulaakulanya, okufulumya, okuguteeka, n’okugukolako gufugibwa, gwesigika, era gutuukana n’amateeka.
2. Obukulu obukulu eri abakola ebintu .
1. "Passport" eri obutale bw'ensi yonna .
Kino kye kikulu ennyo mu bizinensi obutereevu era eky’omugaso. Ebitongole bingi ebifuga mu nsi yonna (nga EU’s MDR/IVDR, US FDA, China’s NMPA, Japan’s PMDA) bikkiriza oba okutwala ISO 13485 ng’omusingi gw’okugoberera amateeka.
Omukago gwa Bulaaya .: Okugoberera ISO 13485 y’engeri enkulu ey’okutuukiriza ebisaanyizo bya QMS eby’amateeka ga MDR/IVDR.
Amerika .: QSR ya FDA (21 CFR Part 820) ekwatagana nnyo ne ISO 13485. Okukakasa ISO 13485 kwanguyiza nnyo enkola y’okubala ebitabo bya FDA.
Obutale obulala .: Amawanga mangi, omuli Canada, Australia, n’amawanga ga Southeast Asia, geetaaga butereevu oba gawa amagezi nnyo nti abakola eddagala lino balina satifikeeti ya ISO 13485.
Awatali satifikeeti eno, abakola ebintu okusinga tebasobola kutunda bintu byabwe mu butale bw’ensi yonna obukulu.
2. Okwongera ku bukuumi n’obulungi bw’ebintu, okukendeeza ku bulabe .
Ekigendererwa ekikulu eky’enkola ya ISO 13485 kwe kulaba ng’ebyuma eby’obujjanjabi bikola bulungi era nga bikola. Nga bateeka mu nkola omutindo guno, abakola ebintu balina:
Okuteekawo enkola enkakali ez’okufuga dizayini .: Okutandika okuva ku byetaago by’abakozesa, okuyita mu kukakasa n’okukakasa, okukakasa nti dizayini y’ebintu ntuufu.
Okussa mu nkola okuddukanya akabi akajjuvu .: Okugatta okuddukanya akabi mu mitendera gyonna egy’obulamu bw’ebintu (okukola dizayini, okufulumya, post- okulondoola akatale) okusuubira n’okufuga obulabe obuyinza okubaawo.
Okukakasa okufuga enkola .: Okutuuka ku mutindo n’okufuga enkola zonna ng’okugula, okufulumya, okwekebejja, okutereka, n’okutambuza okukakasa omutindo ogukwatagana ogwa buli kibinja.
Teekawo enkola y’okulondoola .: okusobola okulondoola ebyafaayo byonna eby’ekintu okuva mu bikozesebwa ebisookerwako okutuuka ku nkomerero-omukozesa, okusobozesa okujjukira okw’amangu era okutuufu singa ebizibu bibaawo.
Kino kikendeeza butereevu ku bulabe bw’omulwadde obulabe, ebikolwa eby’obujjanjabi, n’emisango olw’obulema ku bikozesebwa.
3. Okulongoosa obulungi emirimu, okukendeeza ku nsaasaanya .
Wadde ng’okuteekawo enkola eno kyetaagisa okussaamu ssente mu maaso, mu bbanga eggwanvu, kikendeeza nnyo ku nsaasaanya:
Okukendeeza ku kasasiro n’okuddamu okukola .: Nga essira balitadde ku kuziyiza okusinga okutereeza, okukola ebintu mu butuufu omulundi ogusooka kikendeeza ku ssente z’okusaasaanya, okuddamu okukola, n’oluvannyuma-okuddaabiriza okutunda.
Okussa omutindo ku nkola .: Enkola entegeerekeka n’okugabanya obuvunaanyizibwa bikendeeza ku kusikagana okw’omunda n’okutabulwatabulwa, okulongoosa obulungi emirimu.
Data-Okusalawo okugobererwa .: Enkola eno yeetaaga okwekenneenya n’okulongoosa okusinziira ku data, okuyamba abaddukanya okuzuula ebivaako ebivaako n’okusalawo mu ngeri ey’amagezi.
4. Okwongera okwekkiririzaamu mu bakasitoma, abakolagana nabo, ne bamusigansimbi .
Bakasitoma (amalwaliro, abasawo, abalwadde): Okulaba akabonero ka ISO 13485 certification mark kibaleetera okulaba nga ebintu bya kkampuni eno byesigika era nga bisingako obukuumi, ekizimbe kya brand.
Abaguzi n'abagaba ebintu .: Batera okwetaaga satifikeeti ya ISO 13485 ng’ekyetaagisa okusobola okufuna ebisaanyizo by’abagaba ebintu.
Bamusigansimbi .: Olukusa lulaga nti kampuni eri bulungi-eddukanyizibwa, erina okufuga akabi ak'amaanyi, era nga ye nsimbi ezitebenkedde nga-obusobozi bw'ekiseera obuwanvu.
5. Omusingi omunywevu ogw’okugumira okulondoola okulung’amya .
Amakolero g’ebyuma eby’obujjanjabi gafugibwa nnyo. Okubeera n’eddoboozi, QMS ekakakasiddwa kitegeeza nti ebitongole ebifuga (nga FDA, NMPa) bwe bikola okubala ebitabo ebitannaba kulangirirwa oba okulangirirwa, kkampuni esobola okuddamu mu bukkakkamu, okwongera nnyo emikisa gy’okuyisa okubala ebitabo n’okwewala ebivaamu eby’amaanyi ng’okuggalawo okufulumya, okusasula engassi, oba n’okuwera akatale olw’obutali bwa kuzigula.
6. Okuvuga obuwangwa bw’okulongoosa obutasalako .
ISO 13485 yeetaaga amakampuni okutandika .Ekikolwa eky’okutereeza n’okuziyiza (CAPA) .Enkola n’enkola z’okuddamu okwetegereza enzirukanya y’emirimu. Kino kiwaliriza kkampuni obutawummulira ku laurels zaayo wabula okunoonya n’obunyiikivu ebizibu, okwekenneenya ebivaako ebikoola, n’okukola ebikolwa okuziyiza okuddamu, bwe kityo ne kikola enzirukanya ey’empisa ey’okwefuula -okulongoosa n’okulongoosa obutasalako.
7. Special note: Okwawula ebyuma by’ebyobulamu ku byuma eby’obujjanjabi .
Ensonga enkulu yeetaaga okuggumiza ennyo:Si "ebyuma eby'obulamu" byonna nti "bikozesa bya bujjanjabi."
Ebyuma eby'obujjanjabi .: Egendereddwamu okuzuula, okuziyiza, okulondoola, okujjanjaba, oba okukendeeza ku ndwadde n’ebirala, n’ekigendererwa eky’obujjanjabi ekitegeerekeka obulungi. Okulungamya kwabwe kukakali, era bo .ebiseera ebisinga MUST .Okugoberera ISO 13485 n’ebiragiro ebikwatagana nabyo.
Eby'obulamu/Obulamu obulungi .: Okusinga ekozesebwa mu kuddukanya ebyobulamu, fitness, okulongoosa obulamu, n’ebirala, okutwalira awamu abantu abalamu (okugeza, smart bands eza bulijjo, minzaani y’obuzito, massagers). Okulungamya kwabwe kugonvu nnyo.
Wabula omuze gukyuka:
Ensalosalo ezifuukuuse .: Ebyuma bingi eby’obulamu bw’abakozesa bigamba nti emirimu gyeyongera okumpi n’ekitundu ky’ebyobujjanjabi (okugeza, okulondoola ECG, emitendera gya puleesa), ekiyinza okuvaako okuddamu okugabanyaamu ng’ebyuma eby’obujjanjabi.
Okuzaala abaana mu ngeri ey’okusooka .: Ne bwe kiba nga mu kiseera kino tekibaliddwa nga ebyuma eby’obujjanjabi, bangi mu maaso{0}}okulowooza abakola ebyuma eby’obulamu proactively adopt the ISO 13485 standard kubanga:
Okwetegekera ebiseera eby’omu maaso .: Okwetegekera ebyetaago ebiyinza okuva mu kulungamya okuva mu kulongoosa ebintu oba okugaziya ebifaananyi.
Okulaga okwewaayo okw’omutindo .: Mu katale akavuganya, okukozesa omutindo ogw’awaggulu okukakasa okwewaayo kwabwe eri omutindo n’obukuumi kireeta enkizo ey’enjawulo.
Enkiiko Ezisaba Ez'oku ntikko-Ekkomire Bakasitoma .: Amalwaliro agamu oba amatendekero ag’ekikugu gayinza okwetaaga bannaabwe okuba n’enkola y’okuddukanya omutindo.
Okubumbako
ku bakola ebyuma by’ebyobulamu, .Obukulu bw’okuweebwa satifikeeti ya ISO 13485 busobola okufunzibwa nga:
Mu by'obusuubuzi ., ye .Ekisumuluzo kya zaabu .okutuuka ku butale bw’ensi yonna.
Okusinziira ku ndowooza y'ebintu ., ye .Omukutu .Okukakasa obukuumi n’obulungi.
Okusinziira ku ndowooza y’abaddukanya ., ye .Optimizer .olw’okulongoosa obulungi n’okukendeeza ku nsaasaanya.
Mu ngeri ey’obukodyo ., ye .Ejjinja ery’oku nsonda .olw’okuzimba obwesige n’okutuuka ku nkulaakulana ey’olubeerera.
N’olwekyo, oba eri abakola ebyuma eby’obujjanjabi ebitegeerekese mu mateeka oba eri amakampuni agasaliddwawo okubunyisa ennyo mu by’obulamu n’okuzimba ekika kya premium, okuteeka ssente mu n’okufuna satifikeeti ya ISO 13485 kwe kusalawo okw’obukodyo n’omuwendo omunene ennyo.
Lwaki olondawo ultrasonic cleaners zaffe ku business yo?
·OEM/ODM WEETEGEREZE:Okuwagira okukuba logo, okulongoosa langi, n’okukola dizayini y’okupakinga.
·Omuwendo gw'akatale omunene:Egatta ultrasonic cleaning n’okutta obuwuka mu kyuma kimu ekitonotono.
·Okulondoola omutindo okunywevu:Buli yuniti yagezesebwa ku frequency ya ultrasonic, UV intensity, n’okuwangaala.
·Obwetaavu bw’abaguzi obw’amaanyi:Okwongera okussa essira ku buyonjo bw’omuntu n’obulungi kivuga okuddamu okutunda.
·Okuddaabiriza okutono:Long-ebitundu ebiwangaala n'okukola okutegeerekeka bikendeeza ku kusaba kwa warranty.
Ebikulu Ebirungi .
1. Tekinologiya w’okuyonja emirundi ebiri okusobola okukola obulungi .
Ebirongoosa bya US100 ultrasonic .Egatta .ultrasonic vibration (>42,000Hz)neUV-C Okuzaala ekitangaala ., okuwa enkola enzijuvu 2-mu -1 ey'okuyonja n'okutta obuwuka. Amayengo ga ultrasonic gakola microbubbles ezimenya n’okuggyawo ebisigadde ebikakali, ate UV-C ekitangaala kimalawo 99.99% ku bakitiriya ne virus-eguka obuyonjo obuzitowa, obw’obukuumi nga tebuliimu ddagala.
2. Amataala ga UV nnya-C okumala diguli 360 zonna-Okuzaala .
Eriko .Ebimuli bina ebya UV-C ekitangaala ., ekyuma kino kituuka ku kubikka kwonna munda mu kisenge eky’okwoza. Enteekateeka y’okuzaala ey’oludda olumu ekakasa buli ngulu w’ekintu-ka kibeere ekyuma ky’amannyo oba eby’okwewunda-etta obuwuka kyenkanyi, okutumbula obuyonjo n’obwesige bw’omukozesa.
3. 42KHZ high-Amaanyi ga Frequency aga ultrasonic .
Okukola ku Over .42,000Hz, US100 etuwa amayengo amatuufu, aga waggulu-amasoboza agasobola okuggya ebisasiro ebitonotono ne mu bbanga erinywevu. Kino kigifuula nnungi nnyo mu kuyonja ebifo ng’ebintu ebitonotono ebikwata ku by’okwewunda, emiwaatwa gy’amannyo ag’ekinnansi, n’ebifo ebiri wakati w’ebintu ebikwataganya amannyo.
4. Enzirukanya y’okwoza ey’eddakiika 5 ey’otoma .
OmuUV-C Omulimu guggalawo mu ngeri ey'otoma oluvannyuma lw'eddakiika 5 ., okutangira okukwatibwa ennyo n’okukuuma amaanyi. Omulimu guno ogw’amagezi ogw’obudde gukakasa ebivaamu ebikwatagana, okukola obulungi, n’obukuumi eri abakozesa n’ebintu ebiyonjebwa.
5. Multi-Obusobozi bw’okuyonja mu ngeri ey’ekigendererwa .
Yuniti eno esaanira okukozesebwa mu ngeri nnyingi, ekigifuula eky’omuwendo eky’okugattako ku layini yonna ey’ebintu:
Obuyonjo mu kamwa:amannyo ag’ekinnansi, agakuuma, emitwe gya bbulawuzi, n’okukuuma akamwa k’amannyo.
Amajjolobera:Empeta, emikuufu, obukomo, empeta z’oku matu ne dayimanda.
Ebintu ebya bulijjo:Essaawa ezitayingiramu mazzi, bbandi z’essaawa, ssente, ebikozesebwa mu byuma, n’ebikozesebwa ebitonotono.
6. Okuwangaala era Omukozesa-Enkola ey'omukwano .
Ekyuma kino kizimbibwa n’ebintu eby’omutindo ogwa waggulu-omutindo omugonvu era omutono, kinyuma era kya mugaso. One yaayo ennyangu-okukola button n’enzirukanya ey’otoma bigifuula ennungi okukozesebwa buli lunaku awaka, mu malwaliro g’amannyo, oba mu kiseera ky’okutambula.
Ebisingawo ku bikolebwa .
Huizhou .Gold Rose .Tekinologiya CO,. Ltd yatandikibwawo mu 2017, nga egatta R&D, okufulumya n’okutunda ebintu ebiyamba okuwulira ng’obuuma obuyamba okuwulira, CPAP cleaner n’ebirala. Twewaanira ku ttiimu ya yinginiya erimu obumanyirivu era eyeewaddeyo nga tulina obukugu obusukka mu myaka kkumi mu byuma eby’amasannyalaze n’ebyobulamu ebikwata ku by’obulamu. Abatandisi bava mu nsi yonna-amakampuni agamanyiddwa ennyo nga TCL ne Alibaba. Baweerezza mu kkampuni ya Sony, Harman, Philips, LG ne kkampuni endala. Ttiimu yaffe eya R&D erimu abakola endagamuntu, bayinginiya ba pulogulaamu, bayinginiya ab’amasannyalaze, bayinginiya b’ebyuma, bayinginiya ab’omutindo, bayinginiya b’ebibumbe n’ebirala. Eweereddwayo okulondoola omutindo omukakali n’okuweereza bakasitoma mu ngeri ey’okulowooza, buli kiseera tubaawo okukubaganya ebirowoozo ku byetaago byo n’okukakasa nti bakasitoma bamativu mu bujjuvu. Okugatta ku ekyo, tutuuse ku FDA, CE, FCC, ROHS, SGS ne PSE. 107 obuyinza bw’okuwandiika n’ebintu eby’amagezi eby’obuyinza ku patent z’okuyiiya. Era nga balina obubonero bw’ebintu, ebika n’obuyinza mu China, Amerika, Bulaaya ne Japan. Era twaniriza n'ebiragiro bya OEM ne ODM. Tujja kutondawo mu bwesimbu era tugabana obuwanguzi ne bakasitoma bonna. Mwaniriziddwa okututuukirira okumanya ebisingawo era twesunga okukola naawe.
Funa ekintu ekivaamu .
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 .
certifications zaffe .
SGS .
FC .
CE .
FDA .
Rohs .
Okwekenenya kasitoma .
