Mu rwego rwo gutera amagufwa, amasahani yo kubaga hamwe na screw bigira uruhare runini mugukosora ihahamuka no kubaka amagufwa. Kubitaro, abagabuzi, nibiranga ibikoresho byubuvuzi, guhitamo uwabitanze neza ntabwo bijyanye gusa nubuziranenge bwibicuruzwa - bireba no gukora ubwizerwe, ubushobozi bwo kwihitiramo, hamwe na serivise ndende ihamye.
Nkumunyamwugaamasahani yo kubaga hamwe nuwabitanze, twumva icyingenzi muburyo bwo gutoranya. Muri iki kiganiro, tuzaganira ku bintu bine byingenzi duhereye kubitanga isoko: ibipimo byo guhitamo, ubushobozi bwa OEM / ODM, uburyo bwo gukora, nibyiza bya serivisi.
Ibipimo byo gutoranya amasahani yo kubaga
a. Ibikoresho-byubuvuzi-Biocompatibilité
Urufatiro rwibintu byose byatsinzwe byatewe mumikorere yabyo. Umuti wo mu rwego rwohejuru wa titanium (Ti-6Al-4V) hamwe n’ubuvuzi bwo mu rwego rwo kwa muganga (316L / 316LVM) bikoreshwa cyane kubera imbaraga zidasanzwe, kurwanya ruswa, hamwe na biocompatibilité.
Utanga isoko yujuje ibyangombwa agomba gutanga ibikoresho byuzuye, raporo yikizamini cya mashini, hamwe nimpamyabumenyi ya biocompatibilité kugirango buri plaque na screw byujuje ubuziranenge bwisi yose nka ISO 13485, CE, cyangwa FDA ibisabwa.
b. Igishushanyo mbonera n'imbaraga za mashini
Buri bwoko bwibisahani byamagufwa hamwe na screw bikora ahantu hatandukanye - kuva kumasahani yumugore na tibial kugeza clavicle na sisitemu yo gutunganya humerus. Igishushanyo mbonera kigena imikorere yuwatewe.
Nkumuntu utanga isoko, turemeza neza kugenzura neza umurongo, guhuza isahani, uburyo bwo gufunga imigozi, hamwe n ibizamini byo kurwanya umunaniro kugirango twemeze imikorere n’ubuvuzi. Igeragezwa ryambere, nkibizamini bine byunamye hamwe no kugenzura torque, bifasha kugenzura imiterere ihamye.
c. Ubwishingizi bufite ireme no kubahiriza
Kubahiriza amabwiriza ntibishobora kuganirwaho murwego rwo kuvura. Ababikora bagomba gukomeza sisitemu yo gucunga neza ubuziranenge (QMS) ihujwe na ISO 13485, bagakora ibyemezo bihoraho, kandi bagatanga ibyiciro bikurikirana.
Kuri buri cyiciro - kuva kugenzura ibikoresho fatizo kugeza kubipfunyitse - itsinda ryacu ryiza ryemeza neza ko ryujuje ubuziranenge mpuzamahanga.
d. Ubushobozi bw'umusaruro no guhagarara
Abakiriya basuzuma kandi ubushobozi bwo gutanga ibicuruzwa, igihe cyo gutanga, hamwe n’itangwa ry’imikorere. Umuntu utanga isoko agomba kuba afite imashini ikora, kuvura hejuru, hamwe nubushobozi bwo guterana murugo kugirango habeho guhuza, gukora neza, no gutanga ku gihe.
Uburyo bworoshye bwo gutumiza ibintu - kuva kuri prototype ntoya ikora kugeza ku musaruro munini - ni ikindi kintu cyingenzi cyo guhitamo abaguzi ku isi.
Ubushobozi bwa OEM / ODM: Agaciro Kurenze Gukora
1. Igishushanyo mbonera & Inkunga yubuhanga
Umuguzi w'inararibonye agomba gutanga ubufasha bwo gushushanya kugeza ku ndunduro - uhereye ku kwerekana imiterere ya 3D, gukora prototype, hamwe na FEA (Isesengura rya Element Isesengura), kugeza kwemeza ivuriro.
Itsinda ryacu ryubwubatsi rirashobora gushyigikira isahani yihariye ya geometrie, imigozi yerekana imigozi, amahitamo yibintu, hamwe nubuso burangije, kwemeza ko ibishushanyo byawe byujuje ibyifuzo byubukanishi.
2. MOQ ihindagurika kandi Iterambere ryintangarugero
Kubirango byinjira mumasoko mashya, mato mato yihariye ni ngombwa. Dushyigikiye umusaruro muke wa MOQ, prototyping yihuse, hamwe nogukora ibyiciro byikigereranyo, twemerera abakiriya kugerageza imiterere mishya mbere yo gupima umusaruro mwinshi.
3. Gukwirakwiza ibiciro no gutanga umusaruro mwinshi
Ubufatanye bwa OEM / ODM nabwo buzana ubukungu bwikigereranyo. Hamwe n'imirongo myinshi yo gutunganya CNC, ibikoresho byikora byikora, hamwe nubufatanye buhamye bwibikoresho fatizo, turashobora gukomeza neza neza mugihe ibiciro byumusaruro birushanwe - inyungu nini kubakiriya b'igihe kirekire.
4. Serivise yihariye na serivisi zo gupakira
Usibye gukora ibicuruzwa, turatanga kandi ibirango byihariye, ibicuruzwa byihariye bipfunyika, ibimenyetso byibicuruzwa, hamwe no guteranya ibikoresho. Izi serivisi zongerewe agaciro zifasha abakiriya kubaka ishusho yabo yibiranga neza kandi mubuhanga.
Uburyo bwo gukora no kugenzura ubuziranenge
Inyuma ya buri kintu cyizewe cyimyitozo ngororamubiri kirimo uburyo bugenzurwa kandi bwanditse neza. Reka dusuzume neza umusaruro usanzwe wibikoresho byo kubaga hamwe na screw.
Gutegura ibikoresho bibisi
Dutanga gusa impamyabumenyi yubuvuzi-titanium alloys hamwe nicyuma kitagira umwanda, buri kimwe kijyana nimpamyabumenyi hamwe namakuru yikizamini. Buri cyiciro gishobora gukurikiranwa kugirango gihamye kandi cyizewe mugukoresha amavuriro.
Gukora neza
Gukora CNC numutima wumusaruro watewe. Kuva guhindukira no gusya kugeza kumutwe no gucukura, buri ntambwe isaba micron-urwego rwukuri. Uruganda rwacu rufite ibikoresho byinshi bya CNC hamwe na sisitemu yo kugenzura byikora kugirango ibungabunge ukuri kandi bisubirwemo.
Kuvura Ubuso no Gusukura
Kugirango hongerwe imbaraga za biocompatibilité no kurwanya ruswa, gushiramo bikorwa inzira nka anodizing, passivation, sandblasting, na polishing. Nyuma yo kuyitunganya, ibice byose bisukurwa ultrasonique, bikangirika, kandi bigasuzumwa mubwiherero kugirango byuzuze ubuziranenge bwisuku.
Kugenzura no Kwipimisha
Ibicuruzwa byose binyura mubyinjira, mubikorwa, no kugenzura kwa nyuma (IQC, IPQC, FQC). Ibizamini by'ingenzi birimo:
Ibipimo bifatika hamwe n'ubuso bukabije
Kugenzura uburyo bwo kugenzura
Umunaniro no kwipimisha
Gupakira ubunyangamugayo no kwemeza sterility
Turabika inyandiko zuzuye kuri buri cyiciro kugirango tumenye neza kandi duhamye.
Gupakira Sterile no Gutanga
Ibicuruzwa byarangiye bipakirwa ahantu hagenzuwe, hasukuye kandi birashobora guhindurwa hifashishijwe gazi ya EO cyangwa imirasire ya gamma ukurikije ibyo abakiriya bakeneye. Itsinda ryacu ryibikoresho ryizeza itangwa ryumutekano, ryujuje ibisabwa, kandi mugihe gikwiye.
Ibyiza bya serivisi: Impamvu abakiriya baduhitamo
Imbaraga nyazo zitanga isoko ntizishingiye gusa mubikorwa byo gukora gusa ahubwo no muburyo ifasha abakiriya mbere, mugihe, na nyuma yumusaruro.
1. Igisubizo kimwe
Dutanga igisubizo cyuzuye - kuva kugisha inama kubishushanyo mbonera, kubyara prototype, no gukora cyane kugeza kubipfunyika byabigenewe, inkunga yinyandiko, hamwe nibikoresho - gufasha abakiriya kugabanya ibintu bigoye no kubika umwanya.
2. Igisubizo cyihuse ninkunga yoroshye
Itsinda ryacu ritanga igisubizo cyihuse, icyitegererezo cyihariye, gutunganya byihuse, hamwe nibisabwa kugirango umusaruro uhinduke, byemeza ko buri mukiriya yakira serivisi yihariye.
3. Icyemezo cyisi yose hamwe nuburambe bwo kohereza hanze
Hamwe nibicuruzwa byujuje ibisabwa ISO 13485, CE, na FDA, dufite uburambe bunini bwo gushyigikira iyandikwa ryisi yose muburayi, Aziya, na Amerika ya ruguru. Ibi byemeza ko ibyo winjiza mu mahanga byujuje ibyifuzo mpuzamahanga.
4. Uburyo bw'igihe kirekire cy'ubufatanye
Turabona buri bufatanye nkubufatanye bufatika aho kuba igikorwa kimwe. Intego yacu ni ugufasha abakiriya kuzamura ibicuruzwa byabo, guhindura ibiciro, no kwagura amasoko mashya binyuze mubufasha buhoraho no guhanga udushya.
5. Ibicuruzwa byemejwe Urwego n'inganda zizwi
Ibicuruzwa byacu byihungabana birimo urutonde rwuzuye rwo gufunga, ibyapa bidafunze, imiyoboro ya cortical, imiyoboro ya kanseri, hamwe nibice byo gukosora hanze, byerekana imbaraga zacu R&D nubushobozi bwo gukora. Ubufatanye bwacu bumaze igihe kinini hamwe nabakiriya bisi bugaragaza ibyo twiyemeje kurwego rwiza, neza, no kwizerana.
Guhitamo ibyapa biboneye byo kubaga hamwe na screws bisobanura guhitamo umufatanyabikorwa utanga injeniyeri yuzuye, igenzurwa neza, inkunga yizewe ya OEM / ODM, nagaciro ka serivisi ndende.
Muri Jiangsu Shuangyang Medical Instruments Co., Ltd., duhuza ikoranabuhanga rigezweho mu nganda na serivisi za OEM / ODM zumwuga kugira ngo dufashe ibirango by’ubuvuzi n’abagurisha kugera ku bisubizo byizewe, byubahiriza amategeko, kandi byiteguye ku isoko ibisubizo by’amagufwa.
Waba ukeneye gutera ihahamuka risanzwe cyangwa sisitemu yagenwe yo gukosora, itsinda ryacu ryiteguye gushyigikira umushinga wawe kuva igitekerezo kugeza kirangiye.
Igihe cyo kohereza: Ugushyingo-11-2025