Ihahamuka ryimura OEM: Nigute Wakora Tibiofibular Ifunga Icyapa Abaterankunga bashobora kwizera

Niba uri umugabuzi usuzuma ihahamuka rya OEM umufatanyabikorwa, igice gikomeye ntabwo ari ugushaka uruganda rushobora gukora imashini isahani.

Irimo gushakisha imwe ishobora gukora isahani igoye yo gufunga inshuro nyinshi, kuyandika neza, no kohereza mu buryo bwizewe - nta 'gutungurwa ' mugihe utangiye kwiyandikisha, gutanga amasoko, cyangwa kugenzura.

Iyi nyandiko isenya icyo 'cyiza ' gisa nkugukoresha isahani ya tibiofibular yo gufunga (ikunze guhuzwa nimiryango ya fibula ya kure ya fibula / imigeri ifunga amasahani) nkurugero rwiruka - kuko ikomatanya ubworoherane bworoshye-tissue, kwihanganira gukomeye, hamwe nubwiza bwo gufunga muburyo bugaragaza vuba sisitemu yo gukora idakomeye.

Ibyingenzi byingenzi

• A 'itunganijwe ' intera ya tibiofibular yo gufunga ntabwo yerekeranye no gusaba ibicuruzwa. Byerekeranye nibyiza, gufunga-isura nziza, kugenzura umunaniro-ibyago, no gukurikirana.

• Utanga isoko agomba kuba ashoboye gusobanura (hamwe ninyandiko) uburyo bagenzura TC4 titanium (Ti-6Al-4V) , gutunganya, kurangiza, gusukura, no kugenzura - byinshi nyuma yubufindo.

• Ku masoko yisi yose, ibimenyetso bya laser + UDI byerekana gushushanya no gupakira neza ntabwo 'byiza kugira ' - ni ibyingenzi.

• Niba ushaka kugenda byihuse, amaseti 10 akomeye MOQ irashobora kuba imbaraga zawe zikomeye kugirango ugere kubitegererezo hamwe na PO yambere utiriwe utera ibyago bitemewe.

Niki icyapa cya tibiofibular cyo gufunga gikeneye gukora (mucyongereza cyoroshye)

Tekereza ku isahani ifunga nkibicuruzwa bisobanutse neza. '' Isahani ifite akamaro - ariko isahani + isahani ni sisitemu nyayo.

Niyo mpamvu sisitemu nyamukuru ya plaque / fibula yibanda kumiterere nkibikoresho byo ya titanium isahani idasanzwe , hasi , hamwe nuburyo bwo gufunga byateguwe hagamijwe kunoza ibyakosowe mugihe bigabanya uburakari bworoshye (reba Zimmer Biomet yerekana muri sisitemu ya ALPS Fibula Plating).

Iyo wunvise 'icyuma cya tibiofibular cyo gufunga, ' mubisanzwe urimo usuzuma umuryango wibisahani ugomba gutanga ibintu bine bihoraho - cyane cyane niba urimo ureba kure ya tibiofibular ifunga plaque ya progaramu ya progaramu yihariye-label:

1) Imiterere ya Anatomique ihuye nta kunama gukabije

'Anatomically contoured ' ntabwo ari ikirego kidasobanutse - ni ikizamini gisubirwamo.

Niba kontour yukuri ihindagurika hagati yubufindo, urabona ibibazo byo hepfo: igihe kinini CYANGWA igihe, ibirego byoroheje byoroheje, gushyira ibyapa bidahuye, hamwe ningaruka zo kugaruka / kurega.

Kwifata by'ingenzi : Kuri ubu bwoko bw'isahani, intego yo gukora ntabwo 'urashobora kuyikora rimwe? ' Ni 'urashobora gufata kontour buri gihe? '

Kugirango ubone uburyo sisitemu nyamukuru isobanura iki gisabwa, Zimmer Biomet ishyira muburyo bweruye sisitemu ya ALPS Fibula yububiko hafi yumwirondoro muke, anatomique igizwe na fibula ya kure.

2) Umwirondoro muke, kubera ko ingirabuzimafatizo zoroheje zigarukira

Uturere twa fibula / amaguru afite intera ntoya. '

Urebye kuri OEM, ibishushanyo mbonera bito bizamura ingorane zo gukora kuko impande, radii, hamwe nudusembwa turangiza bigaragara cyane mubuvuzi kandi birashoboka cyane ko bitera ibibazo.

3) Ihuriro rifunga intera ifata uduce duto

Imiryango myinshi ya fibula ya kure ikoresha classe ya kure. Urugero rufatika rwuburyo ibi bisobanurwa kumasoko ni Orthobullets ibisobanuro byerekana isahani ya fibula ya kure ya fibula yerekana '7 umwobo wa kure wa cluster ' yemera imiyoboro ifunga impande zose kandi ishimangira kugabanya uburakari mugihe ufata ibice (reba urupapuro rwa plaque ya Pangea Distal Lateral Fibula).

4) Gufunga umwobo ubuziranenge (kuko 'gufunga ' ntabwo ubabarira)

Gufunga umwobo byibanda ku ngaruka zo gukora:

• imiterere yumurongo nubusugire bwubuso

• Inguni nyayo yinzira

• burr

• gusubiramo mubikoresho hamwe nibice

Kubakwirakwiza, ibi bisobanurwa mubibazo bimwe byubugenzuzi:

Impanuro : Baza OEM uburyo bagenzura ubuziranenge bwo gufunga - ntabwo ari ibipimo gusa , ahubwo imikorere yimbere, kugenzura ibikoresho-kwambara, hamwe nibisabwa.

Ihahamuka ryimura OEM yinganda ( 'bikore neza ' bikurikiranye)

Ihahamuka rikomeye rya OEM umufatanyabikorwa arashobora kugutambutsa mubikorwa byuzuye no kurekura ibintu utihishe inyuma yubucuruzi rusange.

Hasi nuburyo bukwiye ugomba gutegereza kubintu byoroshye bya titanium.

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Intambwe ya 1: Tangira hamwe na titanium iburyo (TC4 / Ti-6Al-4V)

Ku byapa by'ihungabana, titanium yatewe-isanzwe ni sisitemu nyinshi; kurugero, Zimmer Biomet yerekana neza ibikoresho bya plaque nka 'Ti-6Al-4V ELI ' kubisahani bya fibula ya ALPS.

MOQ yawe, kuyobora igihe, nigiciro ntacyo bitwaye niba OEM idashobora kugenzura:

• Icyemezo cyibikoresho hamwe na troncable

• chimie / ubukanishi bwumutungo

• ubugenzuzi bwinjira no gutandukanya

Kutaganira kuriyi gahunda: gushiramo bigomba guhagarikwa nka TC4 titanium (Ti-6Al-4V) -cyiciro cyubuvuzi.

Niba ukoresha isahani nkibipimo, byumvikane neza mubyo usabwa: urimo gushakisha Ti-6Al-4V (TC4) porogaramu yo gufunga icyapa cya titanium, ntabwo ari 'umusimbuzi wa ' titanium.

Intambwe ya 2: Gutunganya neza CNC yubahiriza anatomiya no gufunga intera

Isahani ya geometrike yongeyeho gufunga-umwobo niho ubushobozi bwerekana.

Niki 'cyiza ' gisa:

• uburyo butajegajega, bwemewe bwo gutunganya ibintu byingenzi (gufunga umwobo, cluster ya kure, isahani ya plaque)

• kugenzura ibikoresho-kwambara kugenzura kugirango wirinde gutembera

• inzira zisubirwamo (so cluster yitwara kimwe kuruhande rwinshi)

Aha kandi niho uwatanze isoko 'dushobora gukora 5-axis ' agomba guhinduka: imashini, ibikoresho, na gahunda yo kugenzura byerekana ko bisubirwamo - ntabwo ari urutonde rwibikoresho gusa.

Intambwe ya 3: Gutanga no kurangiza ni umunaniro no kugenzura ibibazo

Kubisahani biri hasi, kurangiza ntabwo kwisiga. Iragira ingaruka:

• kurakara byoroshye byoroshye (ibirego)

• ibyago

• imikorere y'umunaniro (micro-notches irashobora kugira akamaro)

Saba kureba:

• kurangiza ibipimo byemewe

• ibipimo byo kugenzura

• icyitegererezo cyamafoto yinenge namategeko yo gutondeka

Intambwe ya 4: Isuku no kwanduza mbere yo gupakira

OEM yizewe igomba kuba ishobora gusobanura igenzura ryabo (kandi, aho bishoboka, uburyo bwo kwemeza) muburyo butambutsa ibanze.

Ibyo witayeho nkugabura:

• ibisigisigi (coolants, amavuta) nibice ntabwo 'ibibazo bito ' mukwiyandikisha no kugenzura

• gusukura no gutunganya bigomba gushyigikira ubuziranenge bwo gupakira

Intambwe ya 5: Kugenzura, kwipimisha, hamwe nibitekerezo bya 'bibi cyane

No kurwego rwa TOFU, birakwiye gusobanukirwa igitekerezo kimwe kigenga kuko gitanga uburyo abatanga isoko bakuze batekereza:

Ubuyobozi bwa FDA kububiko bwa orthopedic yamenetse yibanda ku guhitamo ibyapa bibi cyane kuri buri karere ka anatomic kugirango bipimishe imashini (reba ubuyobozi bwa FDA PDF Orthopedic Fracture Fixation Plates).

Ntugomba kuba laboratoire kugirango ukoreshe ubu bushishozi. Ukeneye kubaza gusa:

• 'Ni ubuhe buryo bukoreshwa mu bihe bibi kuri uyu muryango w'isahani - kandi ni ukubera iki? '

• 'Ni ibihe bimenyetso ufite kuri urwo rubanza rubi cyane? '

Kuburira : Niba utanga isoko yerekana icyitegererezo kimwe 'cyiza-gisa neza ' kandi akaba adashobora gusobanura ihitamo-ribi cyane, fata ibyo nkibendera ritukura rikuze.

Isoko ryiteguye ibisabwa abadandaza ntibagomba gutandukana

Ikimenyetso cya Laser + UDI ikurikirana

Ku masoko yubahiriza cyane, urashaka ko uruganda rushyigikira:

• urwego rwubuvuzi

• byuzuye UDI ikurikirana kode ishushanya

Muburyo bufatika, iyi ni UDI laser yerekana orthopedic yatewe ikenewe: ubushobozi bwo gushiraho ibimenyetso no gukurikirana ibikoresho buri gihe, byemewe, kandi bigenzurwa.

Ibi ntabwo ari ibirango gusa - ni uburyo bwo kugenzura ibintu. Ihuza gukemura ibibazo byawe kandi igaruka kumusaruro kandi, amaherezo, hamwe nibikoresho fatizo.

Gupakira isuku yububiko + Gamma / EO gucunga neza

Niba ibicuruzwa byanyuma byoherejwe sterile cyangwa bitari sterile, ubushobozi bwa OEM bugomba kubamo:

• isuku ya blister ipakira (ifunze, irinda, ihamye)

• bwo gucunga Gamma / EO Ubushobozi

Iri ni itandukaniro riri hagati ya 'dushobora kohereza ibice ' na 'dushobora gushyigikira gahunda yatewe. '

ISO 13485 + CE - hamwe na dossier inkunga kumasoko ya LATAM

Impamyabumenyi ntabwo ari intero. Ikibazo cyo kugabura ni: OEM irashobora gushyigikira impapuro na disipuline isabwa kugirango yinjire ku isoko?

Nibura, iyi gahunda igomba guhuzwa na:

• ISO 13485 sisitemu nziza iteganijwe

• CE yahujwe na disipulini yinyandiko

Naho intego za LATAM, OEM yawe igomba kuba yiteguye gushyigikira dosiye ya tekiniki yo kwiyandikisha nkigice gisanzwe cyubufatanye.

Ubucuruzi bukoresha OEM nyinshi zidakoreshwa: amaseti 10 akomeye MOQ

Niba wubaka umurongo mushya cyangwa ugerageza OEM nshya, ibintu byihuta.

Amaseti 10 akomeye MOQ ntabwo itanga ubucuruzi gusa - ni igikoresho cyo gucunga ibyago:

• urashobora gusuzuma bikwiye / kurangiza / gushyira akamenyetso / gupakira hakiri kare

• urashobora kwemeza ibyangombwa byakazi mbere yo kwiyemeza kubara

• urashobora kugabanya inzira kumasoko yambere cyangwa kubaga isuzuma

Niba ushaka logique yukuntu MOQ ntoya yihutisha ibyateganijwe mbere, iki gitabo cyimbere ni ingirakamaro: Tangiza ikirango cyawe cya orthopedic hamwe na 10-Gushiraho MOQ.

Gukwirakwiza-OEM igenzura (icyo wabaza mbere yo gutoranya)

Komeza byoroshye. Mbere yo gusaba ingero za porogaramu ya kure ya tibiofibular yo gufunga, baza:

1. Ibisobanuro bifatika : TC4 titanium (Ti-6Al-4V) + urugero rwibyemezo

2. Icyitegererezo cyikitegererezo : urugero rwumubare wububiko + UDI akazi keza + laser yerekana amafoto yicyitegererezo

3. Incamake yinganda : gutunganya + kurangiza + gusukura + kugenzura (urupapuro rumwe)

4. Ibimenyetso byubugenzuzi : urutonde rukomeye urutonde + uburyo ubuziranenge bwo gufunga-umwobo bugenzurwa

5. Amahitamo yo gupakira : isuku ya blister yo gupakira icyitegererezo hamwe nibisobanuro

6. Gucunga Sterilisation : Gamma / EO ubushobozi bwo kuyobora (urugero, kugenzura)

7. Impamyabumenyi : ISO 13485 na CE ibyemezo + ibisobanuro byerekana

8. Inkunga ya dosiye ya LATAM : urutonde rwinyandiko zisanzwe zitangwa kugirango wiyandikishe

Kubindi bibazo byamasoko urashobora kongera gukoresha sisitemu yihungabana, reba: Ibibazo 10 Abagabuzi ba orthopedie babaza mugihe bashakisha ihahamuka ryabatanga.

Ibibazo

1) Niki MOQ yawe kuri progaramu ya tibiofibular yo gufunga porogaramu ya kure?

Kubantu benshi bakwirakwiza bayobowe no kwemeza, amaseti 10 MOQ ni intangiriro ifatika kuko igufasha gusubiramo bikwiye / kurangiza, gufunga umwobo, kwerekana, hamwe ninyandiko mbere yo kwiyemeza kubara binini. Niba ukeneye icyitegererezo gitandukanye (urugero, ibumoso / iburyo bwashyizweho, uburebure buvanze), huza urutonde rwiboneza rwanditse mbere ya PO yambere.

2) Niki ukeneye muri twe kugirango utangire ingero vuba?

Kwimuka byihuse nta gutungurwa kwiza, tegura:

• igishushanyo cyangwa ibicuruzwa byerekana urupapuro (cyangwa urutonde rwumuryango wawe)

• intego yawe isoko (s) n'inzira yo kwiyandikisha (urugero, CE, ibisabwa bya LATAM)

• kuranga / gukurikiranwa ibisabwa (code ya lot, UDI, ururimi)

Noneho OEM igomba kwemeza: kuyobora igihe , gikomeye ibipimo , byo kugenzura , nibizatangwa muri sample pack (certs, raporo, amafoto).

3) Ni ikihe cyiciro cya titanium dukwiye kwerekana kuri aya masahani?

Kuri ubu bwoko bwihungabana, vuga TC4 titanium (Ti-6Al-4V) hamwe nibisabwa bisabwa kugirango umuntu yemeze ibikoresho, ibishobora gukurikiranwa, hamwe nubugenzuzi bwinjira. Niba ufite icyifuzo cya ELI (bikunze kuvugwa ku isoko), vuga neza kuri stade ya RFQ kugirango OEM ibashe guhuza ibikoresho biva hamwe nibyangombwa.

4) Ni izihe mpamyabumenyi zifite akamaro kanini muguhitamo Ihahamuka OEM?

Nibura, ugomba kwitega sisitemu yo gucunga ubuziranenge ISO 13485 ikubiyemo urwego rujyanye (gushiramo hamwe / cyangwa ibikoresho). Ku masoko menshi, disipuline ya CE ihuza inyandiko nayo ni ngombwa. Niba ugamije Amerika, menya ko FDA 510k yihariye ibicuruzwa , baza rero uburyo OEM ishyigikira pake yawe yoherejwe (urugero, inkunga yo kugerageza, gukurikirana, hamwe no kwitegura inyandiko) aho gufata 'uruganda 510k. '

5) Nigute dushobora kugenzura ubuziranenge bwo gufunga umwobo urenze ibipimo byoroshye?

Baza ibimenyetso byerekana ko utanga isoko agenzura gufunga interineti nka sisitemu, harimo:

• kugenzura ibintu byingenzi (ifishi yumurongo, uburinganire bwubuso, inzira / inguni)

• kugenzura ibikoresho-byo kugenzura no kwemerwa

• genda / oya-kugenda cyangwa imikorere yimikorere igenzura aho bishoboka

Saba kandi ibyitegererezo by'ubugenzuzi hamwe nibisobanuro byerekana neza inenge ya burrs, kwangiza urudodo, nubuso bwubuso.

6) Ni izihe nyandiko z'ubugenzuzi zigomba kuzana ingero?

Igipapuro gikomeye cyicyitegererezo gikubiyemo:

• Icyemezo cyibikoresho byintangarugero nibisobanuro byinshi

• raporo yubugenzuzi bukomeye (hamwe nibisubizo byapimwe, ntabwo ari urutonde gusa)

• amafoto yo gufunga-umwobo cluster hamwe nimpande zirangiye

• ikimenyetso / ingero zingero nibisabwa (code nyinshi, UDI akazi)

Niba OEM idashobora gutanga ibi byintangarugero, ni ikimenyetso ubugenzuzi bwawe bwa mbere bushobora kugorana kuruta ibikenewe.

Intambwe ikurikira

Niba urimo gusuzuma ihahamuka ryabafatanyabikorwa ba OEM kandi ukaba ushaka kugenzura ubugenzuzi bwimbere, wubake kuri uyu mutungo mugari: Ubuyobozi buhebuje: Gukora Ihahamuka.

Urashaka kopi-yiteguye kugenzura? Subiza hamwe nisoko ugamije (US-US vs US + LATAM) hanyuma nzabishiraho mumpapuro imwe yo gusuzuma OEM ushobora gusangira nikipe yawe.

Ibindi bikoresho bifitanye isano (niba wubaka umurongo wuzuye w'ihungabana): Ihahamuka ry'abatanga isoko kubatanga.