Orthopedic OEM ODM Amasoko Yimpapuro zera kubatanze muri Amerika y'Epfo

     

Abagabuzi b'amagorofa bo muri Amerika y'Epfo bakorera muri kimwe mu bigenzurwa cyane, ibikoresho - cyane cyane bya medtech. Intsinzi yawe yubucuruzi iterwa nuburyo bubiri ushobora gushiraho: umufatanyabikorwa wa OEM / ODM wahisemo nuburyo wasezeranye kubwiza, gutanga, hamwe niterambere. Uru rupapuro rwera ruguha igitabo cyamasoko kugirango usuzume abatanga isoko, de - kwandikisha ibyago, kandi wubake ubushobozi kubicuruzwa bitandukanye uterekanye ibicuruzwa byawe bitunguranye.

Dore amasezerano: inyungu zikomeye kubagurisha muri Berezile, Arijantine, Chili, Kolombiya, na Peru ntabwo ari igiciro gusa. Ifatanya na orthopedic OEM ODM uruganda rushobora gufatanya nawe - kwemeza inzira, prototyping byihuse, no gushyigikira ikizamini cya gatatu - mugihe ugikubita - gutanga igihe no gutanga SLAs iboneye ushobora kubahiriza.

Iyi nyandiko ni gihamya - iyobowe no kubahiriza - umutekano. Ihuza amasoko y'ibanze cyangwa azwi cyane kubitekerezo byateganijwe hamwe nibikorwa byiza, kandi ihindura ibyo mubikoresho byamasoko ushobora gukoresha ejo.

Ibyingenzi byingenzi

• Shyira imbere ubushobozi bwiterambere: saba porogaramu yemewe yo kwemeza (IQ / OQ / PQ), guhindura SOPs kugenzura, hamwe nibimenyetso / ibikoresho byo gupima ibikoresho byahujwe na ASTM / ISO n'inzira zamasoko.

• Kora ibyo ushobora gupima: gusobanura OTD / OTIF, ububiko bwumutekano, hamwe nibikoresho byihutirwa SLAs byumuryango wibicuruzwa; shyiramo uburenganzira bwo kugenzura nibihano / inguzanyo ihujwe na KPI igenzurwa.

• Kubaka imyiteguro yo kwiyandikisha muburyo bubangikanye: guhuza ibyangombwa bya tekiniki na EU MDR Umugereka wa II / III hamwe na FDA biteganijwe; genzura Burezili B - GMP na Kolombiya UDI ingengabihe hamwe nu mbuga zemewe.

• Baza ibyuzuye bya OEM / ODM byemewe imbere: hindura igenzura ryakazi, inzira yo kwemeza matrix, urutonde rwo gusuzuma prototype, nibikoresho / biocompatibilité / ibimenyetso bya sterylisation.

• Koresha ibiciro ningaruka - uburyo bwo kugabana: MOQ tiers, kuyobora - igihe cyigihe, FX / igiciro cyamahoro - ukoresheje logique, na nyuma y - kugurisha SLA (igisubizo, gusana, ibicuruzwa) kugirango urinde imipaka.

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Kuki gufatanya iterambere hamwe na orthopedic iburyo OEM ODM umufatanyabikorwa ahindura ibisubizo

Abaterankunga muri LATAM bahura nigihe kirekire cyo kugurisha batewe no kubaga abaganga, igihe cyamasoko, hamwe no kwiyandikisha bigoye. Urutonde rusanzwe ntirusanzwe rukubiyemo ibyo abaganga bawe basaba mubyukuri mugongo, ihahamuka, hamwe. Orthopedic OEM ODM umufatanyabikorwa hamwe nibikorwa bikuze byiterambere bigufasha kumenyekanisha ibintu, gusubiramo vuba, no kwerekana ibimenyetso muburyo abagenzuzi na komite zibitaro babyemera.

Niki gitezimbere byumwihariko mugihe ubufatanye nukuri kandi atari intero gusa?

• Igishushanyo cyihuse - kugeza - mbere - urubanza binyuze muri prototyping yihuse ihujwe na gahunda yo kugenzura.

• Impanuka zo hasi mugihe iyo tekiniki yerekana indorerwamo zemewe (urugero, EU MDR Umugereka wa II / III), kandi mugihe gahunda yikizamini itari ivuriro ari igikoresho - gikwiye.

• Itandukaniro rigaragara ryamasoko hamwe nibihinduramatwara hamwe nibikoresho byahujwe n'ibimenyetso byaho - utitaye ku gukurikiranwa cyangwa guhanwa.

Niba usuzumye abatanga ibintu bibiri hamwe nigiciro kimwe, uzahitamo kenshi hamwe ninkuru nziza yo kwemeza: IQ / OQ / PQ yuzuye, kugenzura impinduka zisobanutse neza, hamwe nagatatu - kwipimisha ikizamini. Nguwo umufatanyabikorwa ushobora gutsinda ubugenzuzi bwibitaro no gukomeza umuyoboro wawe.

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Igitabo gikinisha cya LATAM urebye

Burezili - ANVISA RDC 751/2022 na B - GMP

• Icyiciro cya III orthopedic yatewe bisaba Registro na dosiye yuzuye ya tekiniki; ababikora biteganijwe ko bafite icyemezo cya Berezile GMP (B - GMP). Incamake zizwi zisobanura gusimbuza ibice bishaje no guhuza na IMDRF - uburyo bwa tekiniki. Reba isesengura rya Johner Institute ryemeza ibikoresho byubuvuzi muri Berezile no kwemeza imyirondoro yisoko nkurupapuro rwigihugu cya Rimsys muri Berezile kubijyanye nibisobanuro hamwe nibikorwa.

• UDI: Amasoko menshi yinyongera yerekanwe icyiciro UDI yerekana igihe ntarengwa cyo hejuru - ibyiciro byibyago; genzura gahunda iriho kumurongo wa ANVISA amategeko mbere yo kurangiza ibirango na IFU.

Kolombiya - INVIMA UDI nibisobanuro bisanzwe

• Umwanzuro 1405/2022 watangije code ya UDI - DI na raporo yibisobanuro yatanzwe binyuze kumurongo wa INVIMA. Kugisha inama amakuru yerekana uburyo urubuga ruzagenda - live ku ya 8 Gashyantare 2024 kandi ntarengwa ntarengwa kugeza 2025/2026 nicyiciro cyibikoresho. Umusaraba - reba icyiciro cyibikoresho byawe nigihe ntarengwa ku itumanaho ryemewe rya INVIMA. Imvugo y'ingirakamaro: Umusobanuzi wa Veraque Consulting kumurongo ngenderwaho wa semantique na UDI hamwe no kuvugurura isi yose kuva Emergo ivuga muri make ishyirwa mubikorwa.

EU MDR na FDA nkibikoresho byinyandiko

• Gukoresha EU MDR Umugereka wa II / III nkumugongo wibyangombwa bya tekiniki yawe bifasha guhuza ibimenyetso kumasoko. Inyandiko ihuriweho ni kugerwaho kuri EUR - Lex , yerekana ibisobanuro byateganijwe kubikoresho bisobanurwa, ikarita ya GSPR, hamwe no kugenzura / kwemeza ibikubiyemo, kimwe n'ibikoresho bya PMS / PMCF byatewe.

• Inzira zo muri Amerika zigira ingaruka kubiteganijwe ku isi yose ,. Umushinga wubuyobozi bwa FDA kubiteganijwe kugaragara kubikoresho 510 (k) byatewe nibikoresho byikigo ISO 10993‑1 ubuyobozi bwa biocompatibilité busobanura ibyago - kwipimisha gushingiye, kwemeza sterilisation (SAL 10⁻⁶), hamwe na tekinike - ubuzima bwubuzima amakipe atanga amasoko agomba gusaba muri dosiye ya OEM.

Arijantine (ANMAT) na Peru (DIGEMID) - kugenzura umwihariko ku mbuga zemewe

• Amasoko yombi arasaba abafite ibyangombwa kandi byuzuye bya tekiniki, akenshi hamwe na label ya Espagne hamwe na IFU. Kuberako imyifatire hamwe na portal bigenda bihinduka, kora intambwe yo kugenzura muri RACI yawe hanyuma wemeze ibisabwa biheruka kurubuga rwa ANMAT hamwe nu rubuga rwa DIGEMID mbere yuko dossier ihagarara no gucapa.

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Gutanga no gutanga ibintu ushobora gusezerana

Ntushobora gucunga ibyo udasobanura. Mu masezerano no mu nama ya S&OP, amashyaka atandukanye akoresha OTD, OTIF, na 'kuyobora igihe ' bidatinze. Shyira ku rurimi ingingo n'ibipimo kugirango abantu bose babe inyangamugayo kandi batange inguzanyo / ibihano byubahirizwa.

Ibisobanuro nuburyo bukoreshwa

• OTD. Hitamo akanya gato ko gupimwa - ex - itariki y'akazi n'ibimenyetso - byo - gutanga - hanyuma ubyandike muri MSA.

• OTIF (Kuri - Igihe, Muri - Byuzuye): ibyoherejwe bigezwa ahabigenewe, ku gihe, hamwe nibintu byose byumurongo hamwe numubare wuzuye. Kwuzuza igice ntabwo 'byuzuye. '

• Kuzuza igipimo: ijanisha ryumurongo cyangwa ibice byoherejwe v. Byasabwe mumadirishya yasezeranijwe. Koresha umurongo - ikintu cyuzuza igipimo cyo gushiramo gufata miss ariko zikomeye.

Intego zitsinda (ibimenyetso - byamenyeshejwe, kugirango byemezwe muri RFP)

• Ibyingenzi byingenzi (Icyiciro cya III, kubaga - byateganijwe): OTD ≥95%; OTIF ≥93–95%; umurongo - igipimo cyo kuzuza ibintu ≥98% kububiko bwa SKUs. Idirishya ryihutirwa <amasaha 24-48 aho bishoboka.

• Ibikoresho bidasanzwe - ibikoresho: OTD ≥92%; OTIF ≥90–92%.

Imbonerahamwe ifatika ya KPI kugirango ushiremo muri MSA

Ibicuruzwa byumuryango	Ibisanzwe kuyobora igihe (iminsi yingengabihe)	Politiki yo kubika	Intego ya OTD	Intego ya OTIF	Umurongo - ikintu cyuzuye
Gutera umugongo (ingano yabitswe)	14-30	Ububiko bw’umutekano mu karere; ibicuruzwa kuri 30 SKUs	≥95%	≥95%	≥98%
Umugongo wihariye / ihahamuka	30-60	Kubaka - kugeza - gutondekanya	≥92%	≥92%	≥95%
Ibyapa by'ihungabana / imigozi (bisanzwe)	21-45	Umutekano wo hagati hagati + ububiko bwimbere	≥94%	≥93%	≥97%
Gushiraho ibikoresho (kuvugurura / kuzuza)	30-60	Ikidendezi kizunguruka hamwe no kubungabunga SLA	≥92%	≥90%	≥95%

Ibipimo byo gupima: Inyandiko niba OTD ibarwa kubyoherejwe (FCA / FOB) cyangwa gutanga (CIF / DAP) nuburyo imbaraga - zidasanzwe zishobora gukemurwa. Mugihe utanze ibipimo byimbere, ubihuze nuburyo bukoreshwa bwa KPI kuburyo imbaho ​​zawe zihuye nibyo abaguzi babona muri QBR zabo. Kuburyo bwa metodolojiya kubisobanuro bya OTD hamwe nuwabitanze KPI, reba incamake ifatika kuri - igihe cyo gutanga igihe gisobanura imitego yo kubara no guhuza amakipe.

Logistics SLA no gutegura ibihe byihutirwa

• Kwiyandikisha hamwe ninyandiko SLA: kwemeza guhagarika (urugero, inyandiko zatanzwe days3 iminsi yakazi mbere yo kohereza), kugenzura inyemezabuguzi yubucuruzi, hamwe namategeko agenga ibiciro.

• Brokerage no kwemererwa: gutora abahuza; Sobanura ibiti byo kuzamura nibimenyetso - bya - igihe cyagenwe; kubungabunga igihugu - ibitabo byihariye.

• Ibikoresho byihutirwa: codify imbarutso (urugero, kubaga - inyuma yinyuma), uburyo bwo gutwara abantu, hamwe nubuyobozi bwo gufata ibyemezo. Igisubizo cyibisubizo mu <amasaha 24-48 kubibazo bikomeye.

• Traceability na UDI: genzura label / UDI yiteguye kwirinda gasutamo cyangwa kwangwa gufata ibitaro.

Kuki gukomera? Kuberako amanota meza hamwe nabaganga babaga bababaye iyo ingano imwe yinyuma ihagaritse OR umunsi. Mugukora amasezerano ya OTD / OTIF, wunguka levers kugirango ukosore inzira udakoresheje umubano - gukosora gusa.

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OEM / ODM tekiniki yo kwemeza tekinike: uko isa

Numutima wa orthopedic OEM ODM gusuzuma. Baza abashaka gufatanya kubintu byuzuye, bisubirwamo. Intego ntabwo ari impapuro kubwinyungu zayo - ni ukugaragaza ko igikoresho nigikorwa cyibimenyetso bishobora guhangana nubugenzuzi, kwiyandikisha, no kugenzura ibitaro.

1. Hindura kugenzura SOP hamwe nigiti cyicyemezo

• Imbarutso: impinduka yibintu, impinduka zabatanga kubintu byingenzi, kuvugurura gahunda yo gutunganya, guhindura uburyo bwo kuvura hejuru, kuvugurura ingengabihe, kuvugurura / gusubiramo UDI, cyangwa kugurisha ibicuruzwa.

• Isuzuma ry'ingaruka: ryashizwe ku micungire y'ibyago (ISO 14971), GSPRs (niba ukoresheje imiterere ya MDR), hamwe no gutanga isoko. Saba ikimenyetso cya RA / QA - guhagarika nicyemezo cyo gutesha agaciro (nta / igice / cyuzuye) gifite ishingiro.

• Guhuza umurima: niba hari ingaruka zishobora guhungabanya umutekano / imikorere mumurima, menya neza PMS / PMCF ibyinjira no kuzamuka mubikorwa byo kuba maso.

2. Gahunda yo kwemeza inzira (IQ / OQ / PQ)

• IQ: ibikoresho, ibikoresho, verisiyo ya software, hamwe nubushobozi bwibidukikije byanditse kubisobanuro, hamwe nibisabwa byo kwemererwa no gutandukana.

• OQ: ibipimo byibanze mubisanzwe / bibi - urwego rwimanza, kumenya ibipimo byingenzi no gushyiraho imipaka yo kugenzura; ibimenyetso bya GR&R aho sisitemu yo gupima ikoreshwa.

• PQ: umusaruro mwinshi usanzwe ukora werekana ubushobozi (CpK aho bishoboka) hamwe na gahunda yo gutoranya mbere; kuri sterisizione, kwemeza byerekana SAL 10⁻⁶ no gupakira ibipapuro kuri ISO 11607.

• Ikarita yinyandiko: kwemeza igishushanyo mbonera gihuza protocole / raporo kugiti cye, hamwe na DHF no guhindura inyandiko. Kubyiza - imyitozo yuburyo hamwe nibirimo guhuza na EU MDR tekinoroji ya tekinoroji, reba Ikipe - Impapuro za tekinike ya NB.

3. Ibikoresho no gupima dosiye

• Ibikoresho: Impamyabumenyi Yisesengura ikurikirana ubushyuhe / ubufindo kumanota yamenyekanye (urugero, ASTM F136 Ti - 6Al - 4V ELI, ASTM F138 / 139 316L, ASTM F1537 CoCr). Komeza utanga ibicuruzwa hamwe nibisabwa.

• Igeragezwa rya mashini: igikoresho standard ibipimo bikwiye (urugero, ASTM F1717 kubwubatsi bwumugongo, ASTM F2077 kubikoresho bya IBF, ASTM F382 kubisahani, ASTM F543 kumashanyarazi), bibi cyane - inyandiko zo gutoranya imanza, no kugereranya nibikoresho bifatika aho bikenewe. Ibipimo ngenderwaho bya FDA gutangaza ibyapa byavunitse ni urugero rwingirakamaro rwuburyo ibipimo byerekana.

• Biocompatibilité: gahunda ihujwe na ISO 10993‑1 icyiciro cyo kwerekana; kuranga imiti hamwe no gusuzuma uburozi bwa toxicologique aho byerekanwe; ibizamini bya laboratoire.

• Kuringaniza no gupakira: uburyo - kwemeza byihariye nibisigara (niba EtO); Gupakira byemewe kuri ISO 11607 hamwe no gukwirakwiza kwigana hamwe nuburinganire bwa kashe.

• Ibipimo ngenderwaho: ikarita yerekana ikarita yerekana raporo ishyigikira GSPR cyangwa isoko - ibyifuzo byihariye. Kuri kataloge yagutse yatewe - bijyanye, reba Igikoresho cyubuvuzi cya ASTM hamwe nubushakashatsi bwimbitse.

4. Urutonde rwisubiramo

• DFM / DFA: gukora no gusubiramo inteko yanditse hamwe nibikorwa.

• Kuvugurura ingaruka: guhuza isesengura ryibyago nibiranga bidasanzwe.

• Gahunda yo kugenzura: yasobanuye ibipimo byo kwemererwa kuzenguruka prototype (ibipimo, ubukanishi, imikorere) hamwe nintambwe ziteganijwe zikurikira.

• Kurekura ibipimo: uburyo prototype ihinduka igishushanyo - guhagarika umukandida nibindi bimenyetso bisabwa.

Micro ifatika - urugero (kutabogama)

• Mugihe cyo gutanga isoko, itsinda ryanyu rirasaba gahunda yuzuye ya IQ / OQ / PQ kubisahani bishya byinkondo y'umura. OEM yerekana igishushanyo mbonera cyemewe, OQ ibipimo byubushakashatsi bwo gutunganya no gutambuka, na PQ ikora hamwe nincamake yubushobozi bwa CpK. Urugero rwa raporo zivuye mu gutunganya no gupakira kwemeza hanyuma ukemeza ko igeragezwa rya ASTM F382 ryateganijwe ku bubi bukabije bw'imanza. Uru rwego rwo gukorera mu mucyo rusanzwe rwabakuze bakuze; urugero, i serivisi rusange muri XC Medico yerekana ibikorwa bya OEM / ODM hamwe nubushobozi bwo gukora abagabuzi bashobora gusuzuma kugirango bahuze.

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Ibikoresho byo gutanga amasoko nuburyo bwo kugena ibiciro

RFP yawe igomba korohereza abatanga ibikoresho bya OEM ODM bafite imyitwarire isubiza-kandi biragoye kubacuruzi batiteguye guhisha icyuho.

RFP nabatanga ibicuruzwa byingenzi

• QMS n'amabwiriza: ISO 13485 icyemezo; ubugenzuzi bw'imbere mu gihugu; Imikorere ya CAPA; uburyo bwo kugenzura ibishushanyo mbonera; MDR - imiterere ya tekiniki inyandiko yerekana ibirimo; gihamya ya UDI - yiteguye kumasoko yagenewe.

• Gukurikirana no kugira isuku: ubufindo / ubushyuhe bukurikirana kuva mukabari kugeza gushiramo; gahunda ya kalibrasi; gutondekanya isuku no gukurikirana ibidukikije aho bishoboka.

• Kwemeza no kugerageza: kwemeza igishushanyo mbonera; IQ / OQ / PQ imiterere kubikorwa; icya gatatu - ishyaka ryumukanishi / biocompatibilité lab ibyangombwa.

• Ibikoresho na serivisi: kuyobora bisanzwe bande imirongo yigihe cyibicuruzwa byumuryango; Amateka ya OTD / OTIF; ingamba z'umutekano; inzira y'ibikoresho byihutirwa; nyuma - kugurisha SLA (igisubizo, gusana, ibice byabigenewe birahari).

Ibiciro hamwe ningaruka - uburyo bwo kugabana

• Urwego rwa MOQ: guhuza no kunenga SKU no gutondekanya ABC; tekereza MOQs zo hejuru gusa kuri - umuvuduko wa gasutamo.

• Kuyobora - igihe cyitsinda: gutangaza no gusuzuma buri gihembwe; guhuza ibihano / inguzanyo kubura kuri bande kumiryango ibitse.

• FX n'ibiciro: gusobanura pass - unyuze kumupaka no gusuzuma cadence; tekereza kuri bande ya bande ya FX ihindagurika.

• Nyuma - kugurisha SLA: ibihe byo gusubiza kubibazo bya tekiniki (urugero, ≤24h), igihe cyo guhinduranya ibikoresho byo kubungabunga ibikoresho, no kuboneka ibice byasimbuwe.

Iyo RFP yawe ihinduye neza izi ngingo, abatanga ibicuruzwa ubwabo - hitamo. Abashobora gushyigikira iterambere bazatanga pake yo kwemeza, amateka ya KPI, hamwe na gahunda yo kubika ibintu nta gushidikanya.

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Abashoramari ba LATAM bashoboza: kwiyandikisha, amahugurwa ya KOL, nigiciro - ibimenyetso bifatika

Intambwe yo kwiyandikisha no kwitegura gutanga isoko

• Kubaka kwiyandikisha kwawe RACI hakiri kare: ninde utegura IFU na label, ninde ukora urutonde rwa GSPR, ufite ibisobanuro, ninde uhuza nabafite abaho. Kugaragaza EU MDR Umugereka wa II / III byoroshya kwambukiranya - gukoresha isoko kandi bikagenzura neza. Komeza intambwe yo kugenzura kuri Berezile B - GMP imiterere na Kolombiya UDI yoherejwe mbere yo gucapa.

Amahugurwa ya KOL no kurera

• Shushanya uburezi bwo kubaga hamwe na mugenzi wawe OEM / ODM: laboratoire ya cadaver, ibikoresho byumye - ikora, hamwe nubuyobozi bwo gutoranya imanza bihujwe nibikoresho IFUs. Imyitozo yo guhugura, kwitabira, n'ibitekerezo bifasha gushyigikira dosiye zipiganwa hamwe na PMS y'imbere.

Igiciro - gukora neza (ntabwo bivamo ibisabwa)

• Korana n'abayobozi b'ibitaro kugirango ugereranye igiciro cyose: igiciro cyashyizweho, kuboneka kubikoresho, amafaranga yo gusubiramo, igihe cyateganijwe, hamwe nibihano bishobora guterwa. Koresha icyitegererezo kugirango ugereranye amahitamo aho gusezeranya ivuriro ridashoboka.

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Ingingo zo kuganira zirinda abagabuzi

• Kubona ibimenyetso: uburenganzira bwo kugenzura inyandiko zemeza (munsi ya NDA), harimo raporo y'ibizamini no guhindura inyandiko zigenzura.

• Kuyobora - igihe cyagenwe ninguzanyo: inguzanyo zo gutinda gutinda kumiryango ibitse; gusezererwa neza ku mbaraga - majeure yanditse.

• Igisubizo cyihutirwa: gisobanura imbarutso n'inzira y'ibikoresho hamwe nigiciro - kugabana amategeko.

• Guhindura imenyesha: kumenyesha mbere ya Windows kubihinduka byose bisaba guteshwa agaciro cyangwa kumenyeshwa amabwiriza; uburenganzira bwo gusaba igice / cyuzuye.

• Garanti n'ibikorwa byo murwego: inshingano zisobanutse zo gushyigikira iperereza, igihe cyo gusimbuza, no kwibuka inshingano.

• Ihererekanyabubasha rya IP na tekinoroji: kurinda ibishushanyo mbonera byatejwe imbere, amagambo yo gutanga uruhushya niba inganda zigomba guhinduka, hamwe na escrow ya dosiye zishushanyije muburyo busobanutse.

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Intambwe ikurikira

Urutonde rwibikorwa ushobora gutangira muri iki cyumweru

• Urutonde rugufi 3-5 orthopedic OEM ODM kandi utange RFP isaba: ISO 13485, igishushanyo mbonera cyemewe, urugero raporo ya IQ / OQ / PQ, ibikoresho / ibipimo byerekana dosiye, amateka ya OTD / OTIF, politiki yimigabane, hamwe nibikoresho byihutirwa SOP.

• Shushanya ikarita yawe yiyandikishije kandi urebe ibisabwa muri ANVISA, INVIMA, ANMAT, na DIGEMID; guhuza inyandiko yawe ya tekinoroji na EU MDR Umugereka wa II / III hanyuma ukusanye FDA - ihuza ibimenyetso bidafite ishingiro.

• Tegura uburyo bwo gutanga no kugena ibiciro hamwe na bande ya KPI isobanutse, amategeko ya FX / ibiciro, na nyuma ya - kugurisha SLA; gusabana n’imari yimbere nibikorwa mbere yumushyikirano.

Ibikoresho byatoranijwe byemewe hejuru

• EU MDR yahujije inyandiko kuri EUR - Lex kumugereka wa II / III.

• FDA ibiteganijwe kubikoresho 510 (k) ibikoresho byatewe kandi FDA ISO 10993‑1 ubuyobozi bwo gutegura biocompatibilité.

• Incamake yo kwemeza ibikoresho bya Berezile (Institute ya Johner) hamwe na Rimsys Berezile umwirondoro wo gusobanukirwa inzira; kugenzura amatariki ya UDI kurubuga rwa ANVISA.

• Kolombiya UDI / ibisobanuro bisanzwe bisobanura binyuze Ubujyanama bwa Veraque na a ivugururwa ryisi yose kuva Emergo ; kwemeza igihe ntarengwa kuri INVIMA.

• ASTM yashyizweho ibipimo rusange kubikoresho hamwe nuburyo bwo gupima imashini.

• Uburyo bwa OTD busobanura gusobanura KPI guhuza amakipe.

• Ikipe - NB ibyangombwa bya tekiniki nziza - impapuro zimenyereza MDR - imiterere ya dosiye.

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Umugereka: Inkoranyamagambo

• OTD (Kuri - Gutanga Igihe): Ijanisha ryibyoherejwe byatanzwe nitariki yiyemeje kumwanya wa Incoterms.

• OTIF (Kuri - Igihe, Muri - Byuzuye): Ijanisha ryibyoherejwe byatanzwe mugihe hamwe nibintu byose nubunini nkuko byateganijwe.

• IQ / OQ / PQ: Kwishyiriraho, Gukora, no Kwuzuza Impamyabushobozi - ibyiciro bikurikirana byo kwemeza.

• GSPR: Umutekano rusange nibisabwa mubikorwa munsi ya EU MDR Umugereka I.

• SAL 10⁻⁶: Urwego rwo Kwishingira Urwego rugenewe muri terminisation yemewe.

• UDI: Kumenyekanisha ibikoresho byihariye bikoreshwa mukumenyekanisha no gukurikiranwa.

Icyitonderwa kubirango byavuzwe: Uru rupapuro rwera rwarimo rumwe rutabogamye, urugero rwerekana ibikorwa bya OEM / ODM kumurongo wa XC Medico kugirango abasomyi babone uko basuzuma uburyo bwo gukora no kwemeza mubikorwa. Kubijyanye n'imiterere, subiramo Serivisi ya XC Medico.