![Igishushanyo mbonera-cyatewe]()
Gutangiza umurongo-wihariye-orthopedic umurongo ukoreshwa mugusobanura kimwe mubintu bibiri bibi: kwiyemeza gutumiza ikintu cya mbere (kandi usenge ushobora kwimura ibarura), cyangwa kumara amezi ukomye kuko udafite ibishushanyo, dosiye zipakira, cyangwa gahunda isobanutse neza.
Umuderevu muto-MOQ uhindura imibare. Aho gutega amajwi, wemeza utanga isoko, ibyangombwa, hamwe nibisabwa ku isoko hamwe na progaramu ya mbere igenzurwa.
Ibyingenzi byingenzi : Fata '10 shiraho MOQ ' nkikizamini cyisoko , ntabwo ari shortcut. Gutsindira kwimuka ni uguhuza amajwi make hamwe na disipuline yo hejuru: impamyabumenyi yabatanga, ibyangombwa nyirizina, kuranga / UDI yiteguye, no kugenzura kugenzura.
Ibyingenzi byingenzi
MOQ yo hasi igabanya ibyago byo kubara - ariko gusa niba inyandiko zawe na label byiteguye. MOQ yerekeranye nigiciro cyagenwe cyo gukora, ntabwo ari ingamba zo kujya ku isoko. (Reba ibisobanuro bya SeaComp byerekana ingano ntarengwa (MOQ).)
ikarita ya nyirayo . Intsinzi yumuntu ku giti cye ahanini ni
Kuri plaque / screw, kugurisha kwawe ntabwo kwatewe - ni ikizere. Ibitaro naba chirurgie bifuza gukurikiranwa, gukora bihoraho, hamwe nibikoresho byateganijwe.
Gupakira no kuboneza urubyaro birashobora guhinduka icyuho cyawe. Tegura kwemeza no kuyobora ibihe hakiri kare; ntugafate gupakira nkintambwe yanyuma.
Intambwe 0: Sobanukirwa niki '10 gishyiraho MOQ ' igura rwose
MOQ bivuga umubare ntarengwa wateganijwe - ikintu gito cyane uwagikoze azemera kuko aracyafite igihe cyo gushiraho, ibikoresho, gahunda, hamwe nubuziranenge bwibicuruzwa. Niyo mpamvu inganda-MOQ zo hejuru zikunda gusunika 500+: zirinda ubukungu bwazo.
MOQ-10-yashizeho agaciro kuko irakwemerera:
Kwemeza ibyifuzo byo kubaga hamwe na tray akazi hamwe nabakoresha nyabo
Koresha igenzurwa ryagenzuwe mubutaka bwasobanuwe
Emeza ibirango, UDI, hamwe ninyandiko zitemba mbere yo gupima
Irinde guhunika ububiko bwuzuye ingano utaragurisha
Umutego: MOQ yo hasi irashobora kugerageza amatsinda kureka akazi 'kurambirana ' (kugabana inshingano, kuranga, gukurikirana). Ako kazi karambiranye niko gatuma ikirango cyawe kizima.
Intambwe ya 1: Andika 'ikarita yinshingano ' mbere yo guhitamo uwagikoze
Mbere yo kuvuga ibyiciro bya titanium cyangwa kuyobora igihe, banza ugaragaze neza uwabazwa ibyo mubirango byihariye.
Muri Amerika, FDA itegeka kwandikisha ibigo no gutondekanya ibikoresho imbonankubone munsi ya 21 CFR Igice 807 (Kwiyandikisha kwa FDA no gutondekanya ibikoresho). Ibisabwa nyabyo biterwa ninshingano zawe (uwabikoze v.
Ukeneye gusobanuka kumashyaka akora nka 'labeler, ' nibigomba gutondekwa / kwiyandikisha
Ugomba kwirinda imvugo isobanura kwiyandikisha / kurutonde bingana na FDA 'kwemeza '
Ibyo gushira mu nyandiko (byibuze):
Ingano y'ibikoresho (sisitemu nyayo, ingano, ibikoresho)
Guhindura igenzura: ni izihe mpinduka zisaba icyemezo cyawe cyanditse?
Ibirego + CAPA: ninde ukora iperereza, ninde ufunga, ninde utanga raporo?
Kwandika + IFU nyirubwite (harimo ibisobanuro)
Kurema UDI ninshingano zububiko
Inshingano zo gupakira / kuboneza urubyaro hamwe nibisabwa
Kugenzura uburenganzira nigihe cyo gutanga inyandiko
Impanuro : Gufata ibi nkumushinga utanga isoko ryiza. Niba uruganda rudashobora gushyira umukono kumagambo asobanutse yo kugenzura no gukemura ibibazo, 'ikirango ' ni ikirango gusa kuri gahunda yabandi.
Intambwe ya 2: Tora urutonde rwa SKU ibitaro bishobora kugerageza mubyukuri (urutonde rwimikorere ya orthopedic)
Ku byapa by'ihungabana hamwe na screw, inzira yihuse yo gutanga ibitekerezo nyabyo nigikoresho gito, gihuje ibikoresho-ikintu umuganga ubaga ashobora kumva kandi rep irashobora gushyigikira.
Ingero zifatika zisanzwe zisobanura:
Uburyo bumwe bwibanze (urugero, radiyo ya kure ya volar isahani cyangwa agace gato gashizweho)
Ingano ntoya ikora (ihagije kugirango itwikire anatomy, ntabwo buri variant)
Ibikoresho bihuye na sisitemu yatewe (abashoferi, bayobora, bits bits, ibipimo byimbitse)
Intego yawe ntabwo ari ugutangaza ubugari. Intego yawe ni ukugabanya ubushyamirane:
Intambwe ya 3: Emeza ubushobozi bwo gukora nkuko ibitaro bikora: inyandiko-yambere
Abaterankunga bakunze gutsimbarara mubiganiro byihariye mugihe abahagaritse nyabo ari icyuho cyinyandiko. Abakiriya bawe b'ibitaro (n'abashinzwe kugenzura) bazasaba ibimenyetso byavuzwe.
Tangira ukoresheje inyandiko isaba:
Icyemezo cya ISO 13485 (icyerekezo, kigenzurwa)
Ibyemezo byibikoresho (kuri titanium yihariye / PEEK / ibyuma uteganya kugurisha)
Inzira yo gukurikiranwa (ubufindo / icyiciro kugenzura no kwandika)
Uburyo bwo kuboneza no gupakira (niba uzagurisha sterile)
Kugenzura no gutanga ingero zo gutanga raporo
Niba usanzwe ufite urutonde rugufi rwuruganda, koresha urutonde rwabatanga urutonde kandi ukore buri gihe. Niba ushaka abakwirakwiza-biteguye, reba Nigute Wet Abaguzi ba orthopedic: Urutonde rwabaguzi bo muri Amerika.
Intambwe ya 4: Kora revers-injeniyeri ikintu - ntabwo ari ingaruka
Abagabuzi benshi ntibatangirana nubushushanyo bwuzuye bwubuhanga - cyane cyane niba 'aho utangirira ' ari icyitegererezo cyashizweho, umuganga ubaga ukunda guterwa na geometrie, cyangwa sisitemu yo guhangana.
Niba uruganda rwawe rutanga ubwubatsi, saba akazi gasobanutse:
Imiterere yinjiza (icyitegererezo, ifoto, gusikana amakuru)
Imiterere isohoka (2D igishushanyo + 3D CAD + kwihanganira)
Ongera usuzume intambwe (uwasinye, uko ubugenzuzi bugenzurwa)
Gahunda yo kugenzura (ni ibihe bipimo byemeza uburinganire?)
Kurupapuro rwa XC Medico rwa OEM / ODM, barashyira ahagaragara ifoto / icyitegererezo-cyo gushushanya hamwe no gukora inganda hamwe na label 10 yihariye yatangiriye (reba XC Medico OEM / ODM serivisi (10-yashizeho MOQ na turnkey itemba) ).
Koresha ubwo bushobozi witonze: reversing engineering ninyungu gusa niba amateka yo gusubiramo no kugenzura bigenzuwe.
Intambwe ya 5: Wubake label yawe + UDI gahunda hakiri kare (kuko izina ryawe ririho)
Amategeko abiri yintoki:
Ikirango kigomba kwerekana neza uwakoze iki. Amategeko yo kuranga FDA kubikoresho bipakiye avuga ko ikirango kigomba kwerekana izina / aho ubucuruzi bwakorewe, kandi niba ishyaka ryitiriwe ritarakoze igikoresho, umubano ugomba kuba wujuje ibisabwa (urugero, \
UDI ntabwo ihitamo mubikorwa kumasoko akomeye. FDA isobanura muri FDA UDI Shingiro (DI, PI, na GUDID) ko muri rusange UDI ikubiyemo Ikiranga Igikoresho (DI) hamwe n’Ikimenyetso cyerekana umusaruro (PI), kandi sisitemu ishyigikira kumenyekanisha no gukurikiranwa kuva mu nganda binyuze mu gukwirakwiza kugeza ku mikoreshereze y’abarwayi.
Icyo wahitamo muri pilote yawe:
Ikirango cyawe cyubaka (izina ryikirango, ubuzimagatozi, aderesi)
Umutungo wawe wa IFU (ninde wanditse, wemeza ubugororangingo)
Amakuru yawe ya UDI (ukora DI / PI, uko yafashwe muri ERP)
Amategeko yawe yo guhindura-kugenzura (igihe label / IFU ivugurura itera kuvugurura?)
Intambwe ya 6: Ntukemere gupakira / sterilisation bitunguranye gutinda gutangira
Niba progaramu yawe yihariye-label ikubiyemo ibicuruzwa bidafite ishingiro, igihe cyo gutangiza akenshi cyiganjemo kwitegura gupakira.
Kurwego rwo hejuru, orthopedic packaging kwemeza mubisanzwe byerekana ibizamini byashizweho nko gusaza byihuse (ASTM F1980), imbaraga za kashe (ASTM F88), hamwe no kugerageza gukwirakwiza (urugero, ASTM D4169 / D642), nkuko bigaragara mubisobanuro bya ODT mubijyanye no gupakira imitsi no kuboneza urubyaro (ASTM F1980, F88).
Ntugomba kuba injeniyeri yo gupakira - ariko ukeneye gahunda:
Ni ubuhe buryo bwo gupakira ibitaro byawe bizemera?
Ninde ufite ibipapuro byemewe byemewe?
Nigute UDI izashyirwa mu bikorwa (label + AIDC)?
Nuwuhe mwanya wambere wo gupakira ibikoresho hamwe na sterisizione?
Kuburira : Fata ibipfunyika nkigice cyagenwe cya sisitemu y'ibicuruzwa byawe. Niba urangije gupakira bitinze, urashobora 'kurangiza gukora ' ariko ugakomeza kubura itariki yo gutangiza.
Intambwe 7: Koresha indege 10 yashizweho nkubushakashatsi bugenzurwa
Umuderevu muto-MOQ akora mugihe usobanura intsinzi no gutsindwa mbere yo kugurisha seti yambere.
Toranya ibipimo 3-5 bifite akamaro:
Igikorwa cyo gutanga ku gihe
Ibikoresho byuzuye (kubura ibintu kuri buri rubanza)
Ikirango / UDI scan igipimo cyitsinzi mubikorwa byukuri
Igipimo cyo kurega nigihe cyo gusubiza
Igitekerezo cyo kubaga: ergonomique, ubunini, tray logic
Noneho shiraho icyemezo cyoroshye:
Gupima iyo inyandiko + ibikoresho bihamye kandi reorders irahanurwa
Iterate mugihe iyatewe ryemewe ariko igishushanyo mbonera / ibikoresho bikeneye gusubirwamo
Hagarika iyo gukurikiranwa, guhindura kugenzura, cyangwa kwitabira byananiranye
Niba ushaka ihahamuka ryihariye ritanga urutonde rwumwete, ibi byuzuza inzira yicyitegererezo: Ibibazo 10 kuri Vet Ihahamuka ryabatanga (Abanyamerika).
Intambwe ya 8: Gupima ubwitonzi: ongeramo SKUs mubitaro bikurikiranye kubyumva
Inzira yihuse yo kumena ikirango ni ukongera SKUs byihuse kuruta inyandiko zawe hamwe nicyitegererezo gishobora kugufasha.
Uburyo bwo kwagura umutekano:
Kwagura muburyo bumwe umuryango (ubunini bwinshi, hanyuma ibimenyetso byegeranye)
Ongeraho ibikoresho byiza (kugabanya uburemere bwa tray, koroshya intambwe)
Ongeramo sisitemu ya kabiri ihahamuka gusa nyuma yambere ifite reorders ihamye
Ibi bifasha reps yawe gukomeza kwizerwa no kugabanya ibyago byo gutondekanya ibicuruzwa.
Amakosa asanzwe mugihe utangiza umurongo wihariye-label orthopedic umurongo
Gufata MOQ nk'ingamba. MOQ ni ijambo ryo kugura; ingamba zawe nubushobozi + bugenzurwa.
Kureka inyandiko yanditse igenzura. Niba geometrie, ibikoresho, kurangiza hejuru, cyangwa gupakira bishobora guhinduka utabanje kubiherwa uruhushya, ntugenzura ikirango cyawe.
Gupfobya label / UDI igihe. 'Tuzakosora ibirango nyuma ' nuburyo gutangiza bigenda.
Dufate ko ibikoresho bikoresho byoroshye. Mu ihahamuka, gushushanya ibikoresho no kuzuza ibyemezo byokubaga.
Kurenza-ibyiringiro byubuyobozi. Nusobanure neza; ntuzigere usobanura 'FDA yemewe ' kubera ko hari ikintu cyanditswe / cyanditswe.
Ingingo ifatika yo gutangira (niba ushaka gutangiza hamwe na seti 10)
Niba intego yawe ari ugutangiza plaque / screws label yihariye ifite ibyago bike byo kubara, tangira wiyemeje bitatu:
Ikarita yinshingano hamwe namategeko yanditse yo guhindura-kugenzura
Inyandiko isaba ipaki ihuye nuburyo ibitaro bigura
Ikigereranyo cyindege uzakoresha mubyukuri kugirango uhitemo igipimo na iterate
Moderi ya XC Medico ya OEM / ODM yubatswe hafi yikigereranyo cyisoko rito (amaseti 10) hiyongereyeho inganda zinyuranye hamwe n’umusaruro uva (reba urupapuro rwa serivisi rwa OEM / ODM rwahujwe mbere).
Intambwe ikurikira
Niba ubishaka, ohereza intego yawe ya sisitemu yo guhahamuka (inzira, ingano, kandi niba ushaka gupakira sterile). Tuzasubiramo ibishoboka hanyuma dusubiremo indege 10 yashizweho hamwe ninyandiko hamwe na label yo guhuza kuva kumunsi wambere.
Saba amagambo / gutangiza umushinga wa OEM / ODM: Menyesha XC Medico
