Ibibazo 10 Abagabuzi ba orthopedic babaza mugihe bashakisha ihahamuka ryabatanga (Ibisubizo)

Gushakisha ihahamuka ntabwo ari nko gushakisha ibicuruzwa. Waba wongeyeho isoko ya kabiri cyangwa wujuje ibyangombwa bishya byatewe no kuvura ihahamuka, 'utanga ' ni igice cya sisitemu yo kwizerwa yo kubaga - kubera ko buri mugongo, inzira zidahuye, cyangwa impinduka zidafite ibyangombwa amaherezo zigwa mumakipe yawe.

Iyi ngingo ihindura inzira yujuje ibyangombwa muburyo 10 bwo kugabura-witeguye ushobora gukoresha muri RFI, guhamagara abatanga, hamwe nubugenzuzi.

Ibyingenzi byingenzi

• Utanga ihahamuka ni nka 'mwiza ' nkibyangombwa byabo: ISO 13485 ingano, gukurikiranwa, kugenzura impinduka, CAPA , no kwerekana neza uruhare.

• Muri Amerika, genzura uwakoze uruganda rwemewe / labeler , nuburyo FDA 510 (k) , kwiyandikisha / kurutonde, ninshingano za UDI bikemurwa.

• Baza imyitozo yo gukurikiranwa hamwe ninyandiko yanditse ihinduka-imenyesha (hamwe nigihe cyo kuyobora) mbere yuko upima.

• Sisitemu yo guhahamuka itera ibyago byiyongera mubikoresho byabigenewe / kuguriza : kuzura, kwihuta kwihuta, hamwe nuruhererekane-rwo-kurinda nkuko byatewe.

• Funga mubiteganijwe hamwe namasezerano meza + SLA ihujwe na KPI zapimwe (OTD, igipimo cyuzuye, integuza yinyuma yigihe).

1) Ninde ukora ibicuruzwa byemewe n'amategeko hamwe nuwanditseho ibyo bikoresho byihungabana?

Igisubizo: Mbere yo kuvuga kubiciro cyangwa portfolio, menya uwaba afite uburenganzira bwo kuranga no kugenzura inshingano. Niba inshingano zidasobanutse, buri gikorwa cyo hasi (UDI, gukemura ibibazo, kumenyesha guhindura, kwibutsa) biba akajagari.

Icyo gusaba

• Uruhare rusobanutse: uwabikoze, uwateguye ibisobanuro, uwakoze amasezerano, uwatumije mu mahanga, umugabuzi / uwimura.

• Matrix yinshingano yerekana nyirayo:

• kugenzura ibimenyetso

• amabwiriza yatanzwe (aho bishoboka)

• gukemura ibibazo nyuma yisoko hamwe nibikorwa byo murwego

• hindura kugenzura no kumenyesha abakiriya

Niki cyiza

• Umuntu umwe witwa izina arabazwa kuranga no kugenzura dosiye, kandi inshingano zanditswe - ntabwo 'tuzabimenya nyuma. '

Ibendera ritukura

• 'Turashobora gushyira izina iryo ariryo ryose kuri label ' nta bisobanuro bifite ireme / amabwiriza.

• Kubazwa neza mubigo byinshi.

2) Ni ubuhe buryo uhagaze muri Amerika kuri uyu muryango wibicuruzwa - kandi urashobora kubigaragaza?

Igisubizo: Kubikoresho byinshi byamagufwa, kubona isoko biterwa ninzira nyayo igenga inzira n'ibimenyetso. Nibura, ugomba gusobanukirwa niba igikoresho gisaba FDA 510 (k) ihahamuka ryatewe, risonewe (rifite imipaka), cyangwa ritangwa muburyo bwihariye.

Icyo gusaba

• Kubikoresho bisaba kwemererwa: ibisobanuro 510 (k) byerekeranye nuburyo SKUs ibishushanya.

• Kubikoresho bisabwa 'gusonerwa ': ishingiro ryanditse nimbibi (ibisonewe, ibitari byo).

• Gushiraho kwiyandikisha hamwe nibikoresho byerekana urutonde aho bikenewe.

Niki cyiza

• Utanga isoko arashobora gusobanura 510 (k) mumagambo asobanutse akakwereka ibisobanuro byemewe bya FDA Kumenyesha mbere ya 510 (k).

• Bafata kwiyandikisha / kurutonde nkibisabwa byubuyobozi busabwa, ntabwo ari ikirango cyiza, gihuje Kwiyandikisha ibikoresho bya FDA no kurutonde.

Ibendera ritukura

• 'FDA yemeye ' ikoreshwa bisanzwe kubikoresho byo mu cyiciro cya II.

• Nta bikoresho-byumuryango byihariye ( 'Isosiyete yacu yanditswe ' udashushanyije kubyo ugura).

3) Kubatanga ihahamuka: ihahamuka rya ISO 13485 ryaba ryemeza ibyemezo-kandi urwego rurimo ibyashizwemo nibikoresho?

Igisubizo: ISO 13485 nikimenyetso gikomeye cyo gutangira, ariko gusa niba kigezweho kandi igipimo gihuye nukuri (gushiramo, ibikoresho, inzira). Ntukemere ikirango kurubuga nkibimenyetso.

Icyo gusaba

• ISO 13485 icyemezo cya PDF cyerekana:

• gutanga umubiri

• Amatariki yemewe

• ibisobanuro byatanzwe

• aderesi ya site (aho inganda zibera)

• Incamake 'igenzura ryiteguye ' incamake: uburyo bayobora ubugenzuzi bwimbere, ibitagenda neza, na CAPA.

Niki cyiza

• Ingano yicyemezo ihuza neza na orthopedic yatewe / ibikoresho hamwe nibikorwa bijyanye.

• Utanga isoko arashobora kugendagenda muburyo bagenzura ibitagenda neza kandi bakirinda ko bitazongera kubaho - ntabwo 'dufite QC. '

Ibendera ritukura

• Ingano ntisobanutse ( 'gucuruza ' cyangwa 'gukwirakwiza ' gusa) mugihe ukeneye uwabikoze.

• Impamyabumenyi zarangiye cyangwa inzego zitanga zidasobanutse.

4) Urashobora kwerekana amaherezo ya nyuma yo gukurikiranwa hamwe na UDI / kugenzura ibimenyetso (ntibisaba gusa)?

Igisubizo: Traceability niyo ituma yibutsa kubaga aho kuba ibiza. Urashaka gihamya yerekana ko utanga isoko ashobora gushakisha ibicuruzwa biva mu bicuruzwa bigasubira mu bikoresho fatizo hamwe nintambwe zingenzi zikorwa - kandi ko ibirango bigenzurwa kandi bigasubirwamo.

Icyo gusaba

• Incamake yibisobanuro: ubufindo / icyiciro / amategeko yuruhererekane, ibyanditswe, imyitozo yo kugumana.

• Ingamba za UDI hamwe no kugenzura ibirango (kwemeza akazi, kugenzura verisiyo, amategeko-ahindura amategeko).

• Imyitozo nzima ikurikirana kuri SKU / ubufindo:

• ibikoresho fatizo cert → gukora ingendo / inzira records inyandiko zubugenzuzi → gusohora kwa nyuma record inyandiko yoherejwe

Niki cyiza

• Gahunda yabo ya UDI / ikurikiranwa ishyigikira kubahiriza no gukwirakwiza umunsi ku munsi ops (kubara neza, kwibutsa intego).

• Basobanukiwe n'ibinyabuzima byateganijwe kandi barashobora kwerekana ibice byemewe nka Ubuyobozi bwa FDA kuri ISO 10993-1 biocompatibilité (PDF) kugirango isuzume ibikoresho byatewe.

Ibendera ritukura

• Traceability ibaho muburyo budasanzwe nta mpinduka igenzura.

• 'Turashobora gutanga ibirango ' ariko nta nyandiko yemewe yo kwemeza / kurekura.

5) Ni irihe tegeko ryawe ryo kugenzura-kugenzura - kandi ni bangahe utanga mbere yuko impinduka zitangira gukurikizwa?

Igisubizo: Niba utanga isoko ashobora guhindura ibikoresho, ibishushanyo, uburyo bwo kuvura hejuru, cyangwa gupakira udafite gahunda yo kubimenyesha, urashyirwa ahagaragara - cyane cyane mumasoko nigihe ntarengwa cyo kwiyandikisha.

Icyo gusaba

• Inyandiko yanditse-imenyesha SOP ikubiyemo:

• niki gihindura imbarutso yo kumenyesha (igishushanyo / ibikoresho / inzira / kuranga / gupakira)

• ibyangombwa bisabwa (gushyira mu gaciro, ingaruka, ingaruka zo kwemeza)

• menyesha igihe cyo kuyobora kandi niba ushobora gushyira gufata / guhagarika

• Ingero zimenyesha impinduka zabanje (hamwe nibisobanuro birambuye byahinduwe).

Niki cyiza

• Guhindura kugenzura bifitanye isano no gutekereza kubibazo (urugero, ISO 14971).

• Menyesha igihe cyo kuyobora kirasobanutse kandi gifatika (abagabuzi benshi basaba byibuze idirishya ryamenyeshejwe), bisa nuburyo bwasobanuwe muburyo bwo kugabura-buryo-iminsi 30 yujuje ibyangombwa.

Ibendera ritukura

• 'Tuzakubwira niba hari icyahindutse ' nta nzira.

• Impinduka ziyobowe na s-swap swaps nta gusuzuma ingaruka zemewe.

6) Nigute ukemura ibibazo, CAPA, kandi ukibuka ko witeguye - kandi ni ibihe bihe byo gusubiza?

Igisubizo: Ntukeneye gutungana; ukeneye utanga isoko ushobora gukora iperereza, kwandika imizi, no gufunga byihuse. Sisitemu ya CAPA itinda cyangwa yoroheje ihinduka ikibazo cyo gukwirakwiza izina.

Icyo gusaba

• Kurega gufata akazi namakuru yafashwe.

• Akazi ka CAPA (iperereza, kubuza, intandaro, ibikorwa byo gukosora, kugenzura neza).

• Ibuka / ibikorwa byibikorwa muri rusange hamwe na gahunda yo gutumanaho.

• Ibisubizo-igihe byateganijwe byanditse mumasezerano.

Niki cyiza

• CAPA ijyanye nigihe kandi irapimwa.

• Barashobora kwerekana uburyo gukurikiranwa gushigikira ibikorwa bigamije ibikorwa.

Ibendera ritukura

• Nta nzira isobanutse yo kuzamuka.

• Oya 'kugenzura neza ' intambwe (gukosora ntabwo bigenzurwa).

7) Kubicuruzwa bidafite akamaro cyangwa gupakira sterile: urashobora gutanga incamake yo kwemeza no gupakira (ISO 11607 imiterere)?

Igisubizo: Niba igicuruzwa gitanzwe sterile, gupakira no kwemeza sterisation ntabwo byemewe - nibimenyetso byingenzi.

Icyo gusaba

• Gupakira kwemeza incamake (sterile barrière ubunyangamugayo, gukwirakwiza / kohereza ibicuruzwa, ubuzima-shingiro) igihe bibaye ngombwa.

• Sterilisation yo kwemeza incamake hamwe nibisobanuro byo gusohora igihe bibaye ngombwa.

• Ibisobanuro bisobanutse byinshingano: ninde wemeza iki, nicyo wakiriye kuri byinshi.

Niki cyiza

• Kwemeza ibyangombwa birahari kandi birasangirwa muburyo bugenzurwa.

• Utanga isoko arashobora gusobanura impinduka zatera gutesha agaciro.

Ibendera ritukura

• 'Sterile ' isaba nta ncamake yo kwemeza.

• Impinduka zo gupakira zifatwa nkibisiga (ntabwo aribyo).

8) Ni ibihe bihe biganisha, ubushobozi, hamwe nuburyo bwo kubara ushobora kwiyemeza - kandi bigenda bite iyo ubuze?

Igisubizo: Igihe cyo kuyobora ntabwo ari umubare numwe. Ukeneye ibisobanuro byumuryango wibicuruzwa, kureba neza imbogamizi zubushobozi, namategeko yo kugabura mugihe cya spike.

Icyo gusaba

• Kuyobora igihe cyumuryango / SKU band (ibipimo bisanzwe vs bitari bisanzwe).

• Ubushobozi bwo gutangaza hamwe na gahunda yo kwiyongera.

• Amahitamo y'ibarura: ububiko, ibicuruzwa, imvange, cyangwa VMI.

• Itumanaho ryitumanaho cadence n'inzira yo kuzamuka.

Niki cyiza

• Utanga isoko yiyemeje kurwego rwa serivisi rushobora gupimwa (OTD, igipimo cyuzuye, kumenyesha inyuma igihe cyo kuyobora), bigahuza nuburyo bwo kugabura-uburyo bwa KPI (kandi ntabwo ari amasezerano gusa).

Ibendera ritukura

• Kurenza urugero kuyobora ibihe nta makuru cyangwa kugabura logique.

• 'Turashobora gukora ikintu cyose cyihuse ' tutabariyemo ibarura.

9) Nigute ukoresha ibikoresho bya orthopedic tray yinguzanyo zinguzanyo - kuzura, kugarura, no kumurongo-wo-kurera?

Igisubizo: Sisitemu yo guhahamuka inanirwa gukora kenshi kuruta kunanirwa muburyo bwa tekinike. Ububabare bwawe bukomeye buzaba icyuho, ibikoresho byabuze, no guhinduka buhoro.

Icyo gusaba

• Ikarita yimiterere ya tray hamwe nu rutonde rwo gupakira kuri buri seti.

• Inzira yuzuye yo kugenzura inzira (ninde ugenzura, igihe, nuburyo ibibazo bikemurwa).

• Intego zo guhinduranya kugirango usubire, usane, kandi usimburwe.

• Urunigi-rwo-gutegereza kubaguriza (amanota ya handoff, imipaka yinshingano).

Niki cyiza

• Urashobora gukora sample 'shiraho ibyuzuye ' ubugenzuzi: ese itangwa ryatanzwe rihuye nurutonde rwabapakiye, hamwe na label ikwiye kandi igashyirwa?

• Gusubiramo no gusimbuza ibikoresho igihe cyasobanuwe kandi gipimwa.

Ibendera ritukura

• Nta rutonde rusanzwe rwo gupakira cyangwa nta kugenzura verisiyo.

• 'Tuzongera ibikoresho nyuma ' nk'imyitozo isanzwe.

10) Uzasinya amasezerano meza na SLA-kandi ni ayahe magambo yubucuruzi arengera impande zombi?

Igisubizo: Niba kitanditswe, ntabwo arukuri. Amasezerano meza asobanura uburyo mukorana; SLA isobanura icyo 'serivisi nziza ' bivuze; amagambo yubucuruzi asobanura uburyo musangiye ibyago.

Icyo gusaba

• Amasezerano meza (cyangwa inyandikorugero) akubiyemo:

• Guhindura imenyesha

• kurega / CAPA inshingano nigihe ntarengwa

• gukurikiranwa no kubika inyandiko

• uburenganzira bwo kugenzura

• Ikarita ya SLA ifite agace gato ka KPIs (OTD, igipimo cyuzuye, kumenyesha inyuma igihe cyo kuyobora, gusimbuza ibikoresho).

• Amagambo yubucuruzi: MOQs, incoterms, garanti / kugaruka, imipaka idasanzwe, n'amagambo ya IP kuri OEM / ODM.

Kubisobanuro byururimi rusobanutse kubigomba kuba imbere, uwasobanuye Greenlight Guru kubyo amasezerano yubuziranenge bwibikoresho byubuvuzi agomba kuba akubiyemo ni intangiriro yingirakamaro (imiterere yingirakamaro mugihe utegura amasezerano yubuziranenge bwibikoresho byubuvuzi).

Niki cyiza

• Utanga isoko yiteguye gupimwa - no gusobanura uko bigenda iyo intego zabuze.

Ibendera ritukura

• Kwanga gushyira umukono ku masezerano ayo ari yo yose.

• KPIs zaganiriweho mu magambo ariko ntizigera zandikwa.

Byoroheje byiminsi 30 yujuje ibyangombwa ushobora kongera gukoresha

Niba ushaka inzira isubirwamo ikora kumasoko no kugenzura:

• Iminsi 1-10: Inyandiko-yambere yerekana (certs, gukurikirana, kugenzura impinduka, CAPA, inshingano)

• Iminsi 11–20: Kwemeza ibikorwa (icyitegererezo, icyerekezo cyuzuye, kuyobora igihe cyukuri-kugenzura)

• Iminsi 21-30: Funga mumategeko (amasezerano yubuziranenge + SLA, hanyuma umuderevu ufite agace gato kagurishwa)

Ibisobanuro birambuye byuru rugendo rwerekanwe mubuyobozi bwa XC Medico kuri guhahamuka abatanga isoko kubagabura.

Niba kandi ushaka urutonde rwagutse, rudafite ihungabana rwihariye kugirango uhuze, tangira nibi ibyiciro bibiri byo gusuzuma.

Intambwe ikurikira

Niba ubishaka, urashobora guhindura ibi bibazo mubipapuro byurupapuro rumwe rwa RFI hamwe nurutonde rusaba urutonde, imbonerahamwe ya SLA KPI, hamwe na rubricike itukura-ibendera.

Urashobora kandi kwambukiranya inzira yawe igezweho kuribi Urutonde rwibintu byamaganwe muri Amerika bitanga urutonde.