Nigute Wabona Ikiguzi-Cyiza cya orthopedic abatanga ibicuruzwa bitabangamiye ubuziranenge

Gushakisha kwisi yose birashobora kugabanya rwose ibiciro byatewe. Ariko kubagabuzi, akazi nyako ntabwo 'shaka uwaguhaye ibicuruzwa bihendutse. ' Nibiciro biri hasi yubutaka mugihe ukomeje igihe cyo kwiyandikisha, kwakira ibitaro, hamwe n’umutekano w’abarwayi..

Hasi nuburyo bufatika, busubirwamo ushobora gukoresha kugirango wuzuze ibicuruzwa bitanga amagufwa meza-utize inzira igoye binyuze mubukererwe bwamasoko, kugaruka, cyangwa ibikorwa byakwirindwa.

Ibyingenzi byingenzi : Igiciro gito ntigisobanutse niba utanga isoko adashobora kwerekana ibimenyetso, kugenzura ubugenzuzi, hamwe no gucunga impinduka.

Ibyingenzi

• Koresha impamyabumenyi yabatanga nkumushinga wibyago, ntabwo ari ibiganiro byigiciro. Tangira utaganira, hanyuma utange amanota kubatanga rubricike yanditse.

• Kugenzura igipimo cyemeza, ntabwo ari ibirango gusa. Baza ibyemezo bya PDF, aderesi zurubuga zagenzuwe, hamwe ningero zerekana zijyanye no gushyirwaho.

• Saba 'inyandiko yuzuye ' hakiri kare. Nibiyungurura byihuse gukura - kandi bigukiza amezi mugihe cyo kwiyandikisha no gutanga amasoko.

• Kugenzura inzira zitera ibiciro byihishe. Ibihe byo gusubiza CAPA, kwemeza-inzira idasanzwe, no guhindura ibintu kugenzura kuruta agatabo keza.

• Fata ubuziranenge nkuko bikomeza. Funga inshingano mumasezerano yubuziranenge kandi ukurikirane imikorere hamwe namanota.

Kuki 'bihendutse ' abatanga ibicuruzwa bihenze vuba

Ababitanga mubisanzwe bumva ububabare bwabatanga nabi ahantu hatatu:

1. Kwiyandikisha no gutinda kw'ipiganwa (kubura cyangwa intege nke za tekiniki).

2. Tanga ihungabana (kuyobora ibihe birambuye iyo bisabwa).

3. Ibintu byiza (ibirego, gukora, kugaruka, iperereza, hamwe nigihe cyimbere kizana nabo).

Iyo rero ugereranije amagambo, ntugahagarare kubiciro byigice. Wubake isuzuma ryawe hafi yikiguzi uzishyura:

• Igihe cyinyandiko (itsinda ryanyu + abajyanama bashinzwe kugenzura)

• Kohereza no guhinduka kwa gasutamo

• Ibyago byo kubara (kutaringaniza ibicuruzwa, kugenda buhoro, kurangira)

• Gukemura ibyabaye byiza (ibirego, gukurikirana CAPA, gusubiza ibikoresho)

• Hindura ingaruka (ongera ushireho ikimenyetso, wongere wemeze, wongere utange)

Intambwe ya 1: Sobanura ibyifuzo byawe bitaganira kubijyanye na orthopedic implant itanga impamyabumenyi

Ibiciro-bitanga isoko byoroshye mugihe usobanuye 'musts ' imbere. Bitabaye ibyo, buri mutanga isoko yumvikana neza-kugeza igihe cyo kwiyandikisha cyangwa gutanga.

Tangira hamwe nibi bine bitaganira:

• Amasoko agamije : Amerika gusa, EU gusa, cyangwa uturere twinshi?

• Ingano y'ibikoresho : ihahamuka, umugongo, ingingo, ibikoresho, sterile, nibindi.

• Inzira ziteganijwe gutegurwa : ni ibihe bimenyetso ukeneye kwiyandikisha kwawe hamwe nibitaro byinjira.

• Ibisabwa gukurikiranwa : ubufindo / icyiciro / ibyateganijwe, ibyifuzo bya UDI, nibihe byo kugumana.

Impanuro : Andika ibyo utaganira nkibisobanuro byombi ( 'bigomba gutanga X by Y itariki ') kugirango abatanga isoko badashobora guterana amaboko.

Intambwe ya 2: Kubaka amanota kubatanga orthopedic itanga ikiguzi

Amanota agufasha kugereranya abatanga ibintu mubintu bitera ibisubizo - cyane cyane iyo uringaniza ibiciro hamwe ningaruka. Irinda kandi 'igiciro cyingirakamaro-orthopedic abatanga ' kidahinduka 'abatanga ibicuruzwa bihendutse wicuza. '

Dore imiterere yoroshye ushobora guhuza:

Icyiciro	Ibyo utanga amanota	Urugero rwibimenyetso byo gusaba
Ubwiza & Igenzura	QMS ikuze, igenzura ryiteguye, kurega / indero ya CAPA, gukurikirana	ISO 13485 icyemezo (urugero + urubuga), CAPA SOP, gukemura ibibazo SOP, urugero rwo gukurikirana
Ibikorwa	Ubushobozi, kuyobora ibihe, gutanga ku gihe, kubara kugaragara, gupakira / kugenzura ibicuruzwa	Ubushobozi bwerekana, kuyobora-igihe SLA, amateka yo gutanga ku gihe, urutonde rwimigabane, gupakira ibintu
Ubucuruzi	Igiciro cyerekanwe neza, MOQ, amasezerano yo kwishyura, igiciro gihamye, garanti / amasezerano yo kugaruka	Amagambo + Incoterms, urutonde rwa MOQ, igihe-cyemewe, politiki yo kugaruka

Ibi bikora ibintu bibiri:

• Irinda 'igiciro cyo hasi gutsindira ' icyemezo cyaje gusenyuka.

• Iraguha inzira isukuye yo kwemeza guhitamo abaguzi imbere (no mumatsinda yibitaro abaza uko wujuje isoko yawe).

Intambwe ya 3: Ipaki yinyandiko yo gusaba (ikizamini cyawe cyo gukura byihuse)

Mbere yo guteganya ubugenzuzi kurubuga, saba paki yinyandiko. Abatanga imbaraga barashobora gutanga ibi byihuse - kuko basanzwe babikeneye kubakiriya nabashinzwe kugenzura.

Hano hepfo ni urutonde rwibikoresho byubuvuzi bitanga urutonde rwubugenzuzi bwurwego rwa RFI / RFQ (umudozi ukurikije icyiciro cyibikoresho hamwe nisoko ryerekeza):

A) Impamyabumenyi n'ibimenyetso by'ubugenzuzi

• Icyemezo cya ISO 13485 (PDF) hamwe nuwabitanze, nimero yicyemezo, amatariki yemewe, aderesi yurubuga yagenzuwe, nubunini

• CE ibyemezo byicyemezo (aho bikenewe) nibisobanuro byumubiri wabimenyeshejwe

• Ibimenyetso byerekana ko ubugenzuzi bwiteguye (incamake yubugenzuzi, gahunda yo kugenzura, uburyo bwo gukemura ibibazo)

Kugirango ubone incamake y'ibyo ugomba gusuzuma mubugenzuzi bwibikoresho byubuvuzi, Igitabo cyerekana ibimenyetso ku igenzura ryibikoresho byubuvuzi rishyiraho ibice byingenzi nka CAPA, kugenzura inyandiko, guhuza ibyago, no kugenzura imbere.

B) Gukurikirana no kuranga

• Uburyo bwo gukurikirana: uburyo ukurikirana ibikoresho bibisi → WIP goods ibicuruzwa byarangiye → kohereza

• Icyitegererezo cyo kuranga hamwe na IFU akazi

• Uburyo bwa UDI (niba amasoko yawe abisabye) namakuru ki atwarwa murwego rwo gupakira

C) Sisitemu nziza 'igomba-kureba ' inzira

• Uburyo bwa CAPA + urugero CAPA inyandiko (yahinduwe)

• Uburyo bwo gukemura ibibazo + urugero rwibirego (byahinduwe)

• Hindura uburyo bwo kugenzura (igishushanyo + inzira + impinduka zabatanga)

• Uburyo bwo gucunga amasoko (uburyo bujuje ibisabwa kubatanga isoko)

D) Gukora ibimenyetso no kwemeza

Kubijyanye na orthopedic hamwe nibikoresho, ubushobozi bwibikorwa akenshi niho ingaruka zihishe.

Baza:

• Ibikorwa byingenzi bigenda (gutunganya → kurangiza → gusukura → kugenzura → gupakira)

• Uburyo bwo kugenzura no kugenzura ibipimo bya CTQ

• Ibimenyetso byihariye byo kwemeza ibimenyetso aho bikenewe (inzira aho udashobora kugenzura neza umusaruro ukoresheje ubugenzuzi bwonyine)

E) Itangwa rya sterile (gusa niba ibicuruzwa bitagira ingano biri murwego)

Niba ukwirakwiza sterile yatewe cyangwa sterile tray / set, saba:

• Uburyo bwo kwemeza uburyo bwo kurekura no kurekura ibipimo

• Ibikoresho byo gupakira hamwe nuburyo bwo kwemeza

• Ubuzima bwa Shelf / ubunyangamugayo bufite ishingiro (nkuko bikenewe)

Kubisobanuro byo murwego rwohejuru rwerekana ibimenyetso bya CE hamwe nisuzumabumenyi ryakozwe muri MDR, incamake ya Kiwa yerekana CE yerekana ibikoresho byubuvuzi munsi ya MDR ni intangiriro yingirakamaro mugihe uhuza ibyateganijwe.

Intambwe ya 4: Kugenzura ibyingenzi (kandi ntukemere ko ingendo zikurangaza)

Niba inyandiko yinyandiko inyuze muyungurura, hanyuma ugenzure. Intego ntabwo ari 'kubona uruganda rufite isuku. ' Nukwemeza ko sisitemu yubuziranenge yabatanga ari nyayo kububiko.

Witondere ubugenzuzi bwawe kuri:

• Kugenzura inyandiko mubikorwa : Bashobora kugarura verisiyo yihuse? Abakoresha barayikurikiza?

• Kwerekana Traceability : Tora SKU yarangije ukurikirane inyuma (ibikoresho, ubugenzuzi, amateka menshi).

• Ubwiza bwa CAPA : Iperereza ryaba intandaro-iterwa-cyangwa gusa 'kongera abakozi '?

• Guhindura igenzura : Nigute basuzuma ingaruka zubuyobozi / abakiriya mbere yo gushyira mubikorwa impinduka?

• Igenzura ryabatanga isoko : Nigute bujuje ibisabwa abatanga ibikoresho byingenzi nibikorwa byo hanze?

Niba urunigi rwawe rutanga uturere twinshi, MDSAP irashobora kuba ikimenyetso cyingirakamaro. Incamake ya porogaramu kuri MDSAP ni iki? n'urucacagu rwa uburyo bwo kugenzura MDSAP bwerekana uburyo icyitegererezo cyubugenzuzi cyubatswe mubikorwa byingenzi bya QMS.

Kuburira : Utanga isoko adashobora gusangira ingero zahinduwe (CAPA, kurega, gukurikirana) hari icyo akubwira - mubisanzwe ko sisitemu idakuze.

Intambwe ya 5: Funga ubuziranenge hamwe namasezerano yubuziranenge no gukurikirana bikomeje

Ndetse nabatanga ibintu bikomeye baragenda nta nshingano zisobanutse.

Nibura, Amasezerano yawe meza agomba gukubiyemo:

• Inshingano / inshingano kubibazo, iperereza, nigihe cyo gutanga raporo

• Hindura amategeko yo kumenyesha (ni izihe mpinduka zisaba kumenyeshwa / kwemererwa nigihe kingana iki)

• Gukurikirana no kwandika ibisabwa byo kubika

• Kudakurikiza amategeko agenga ibicuruzwa no kubitwara

• Garuka, gusimbuza, hamwe na garanti yemewe

• Uburenganzira bwo kugenzura no kugenzura inshuro (zishingiye ku ngaruka)

Noneho ukurikirane imikorere hamwe na scorecard yoroheje buri gihembwe:

• Gutanga ku gihe (OTD)

• Itandukaniro-Igihe

• Igipimo cyo kurega nigihe cyo gufunga

• CAPA

• Igihe cyinzira cyigihe (burya batanga vuba ibyo ukeneye)

Niki gihamya ikomeye itanga ibimenyetso ishobora kumera (urugero rutabogamye)

Uruganda rukuze rwamagufwa rukuze rushobora kwerekana (cyangwa gutanga kubisabwa):

• Ibimenyetso bisobanutse neza (ISO 13485 / CE aho bibaye ngombwa) bifite intera iboneye

• Kwagura kataloge yagutse hamwe na SKU disipuline (kugirango ubashe gutunganya amaturo)

• Ibisobanuro byiyemeje gutanga (hamwe nibigaragara neza, ntabwo amasezerano adasobanutse)

• OEM / ODM inzira isobanutse (niba wihariye-label cyangwa uyihindura)

Kurugero, XC Medico yihagararaho nka orthopedic yatewe kandi ikora ibikoresho hamwe na portfolio yagutse kandi isaba ibyemezo; urashobora gusubiramo rusange muri rusange Ubwiza bwa XC Medico nubukorikori rusange hamwe nibicuruzwa kuri Ibyiciro bya XC Medico . Nkibisanzwe: fata impapuro rusange nkintangiriro-hanyuma ugenzure hamwe nimpamyabumenyi ya PDF, ingano, nibimenyetso byanditse.

Niba OEM / ODM igizwe na moderi yawe yo gushakisha, XC Medico nayo itangaza amakuru arambuye yimbere yakozwe nka an orthopedic OEM / ODM igenzura ryamasoko , irashobora gukuba kabiri nkicyitegererezo cya RFI yawe.

Ibibazo

Ni izihe mpamyabushobozi zigomba gutanga orthopedic utanga isoko?

Nibura, abadandaza benshi bafata ISO 13485 nkibanze shingiro ryimicungire yubuvuzi bwiza. Mugihe wubaka 'ISO 13485 yemewe na orthopedic uruganda rukora ' urutonde, ntukemeze gusa ko icyemezo gihari - genzura urugero rwacyo (gushiramo / ibikoresho), urubuga rwagenzuwe , n'amatariki yemewe.

Hejuru yibyo, ibyemezo bisabwa biterwa nisoko ugamije hamwe nicyiciro cyibikoresho (urugero, 'CE ikimenyetso (EU MDR) cyerekana amagufwa ' gihamya kumasoko ya EEA, na 'FDA 510 (k) imitekerereze ya orthopedic ' ibimenyetso byerekana ko Amerika ikwirakwizwa). Urufunguzo nugusuzuma agaciro nubunini bigezweho - ntabwo ari ikirango gusa kurubuga.

FDA 510 (k) ni icyemezo cyabatanga?

Oya A 510 (k) nicyemezo cyo kwamamaza kubikoresho runaka, ntabwo ari icyemezo rusange cyisosiyete. Icyo ushobora gusaba uwaguhaye isoko ni ibimenyetso byihariye byerekana ibikoresho (mugihe bibaye ngombwa), wongeyeho ibimenyetso byerekana sisitemu nziza kandi irashobora gushyigikira ibyangombwa ukeneye.

Kubijyanye n’ibanze muri Amerika, FDA ibikoresho byubuvuzi hub ni intangiriro nziza kumurongo wemewe.

Nshobora gukoresha ISO 13485 wenyine kugirango nizere uwaguhaye isoko?

Fata ISO 13485 nkuko bikenewe, ntibihagije. Icyemezo kirakubwira QMS yagenzuwe - ariko ntabwo yemeza imikorere mubicuruzwa byawe byuzuye, kuyobora-igihe, cyangwa guhindura-kugenzura. Niyo mpamvu impapuro zipapuro + zerekana ibimenyetso + CAPA icyitegererezo.

Nigute nshobora kuringaniza MOQ yo hasi hamwe nubwiza buhoraho?

MOQ yo hasi irashobora kuba akarusho kurushanwa, ariko irashobora kandi guhisha ihungabana (kubaka byihuse, ubufindo budahuye, cyangwa guhindagurika kubatanga isoko). Niba utumiza uduce duto, uzakenera amasezerano akomeye kuri:

• icyiciro cyo kurekura inyandiko

• kugenzura icyitegererezo

• hindura imenyesha

• igihe cyo gusubiza ibibazo

Intambwe ikurikira

Niba ushaka kugenda byihuse udatwaye ibyago bitari ngombwa, kora ibi bikurikiranye:

1. Ohereza urupapuro rumwe RFI usaba urutonde rwinyandiko zigenzura hejuru.

2. Abatanga amanota kuri rubric imwe (Ubwiza / Kugenzura, Ibikorwa, Ubucuruzi).

3. Kugenzura gusa abarangije - kandi wibande kugenzura kugenzura, ubuziranenge bwa CAPA, no kugenzura kugenzura.

Niba urimo gusuzuma abaguzi muri spine, ihahamuka, hamwe na sisitemu ihuriweho kandi ukaba ushaka urutonde rwibintu 'inyandiko nziza + imihigo yo gutanga ' bishobora kumera, urashobora gutangirana nabagabuzi-bareba muri rusange XC Medico no gusaba ibyemezo hamwe nimpapuro zemeza kugenzura.