Zã ɖaseɖiɖi ewo siawo nàtsɔ asɔ kple ƒumeŋuɖui wɔlawo le se ƒe lolome, alesi woate ŋu ake ɖe wo ŋu, woƒe nyonyome dzi kpɔkpɔ, alesi wodzrae ɖo, asitsatsa ƒe ɖoɖowo kple kpekpeɖeŋu si wonana ɣeyiɣi didi ŋu—menye le asixɔxɔ si wogblɔna ɖeɖeko ŋu o.
Ŋuɖoɖo kaba
Ele be ƒumeŋuɖuiwɔƒe si ŋu kakaɖedzi le nate ŋu ana kpeɖodzi—menye ŋugbedodowo ɖeɖeko o—siwo ku ɖe eƒe se ƒe dzesideŋkɔ, nyonyome-dzikpɔkpɔ ƒe kekeme, asi ƒe mɔɖeɖe ɖe adzɔnu tɔxɛwo ŋu, nusiwo woatsɔ akpɔ nuawo yome, aɖaŋu kple dɔwɔwɔ ƒe kpeɖodzi, ewɔwɔ ƒe ŋutete, OEM ƒe sewo, nuwo ɖoɖoɖa dzi kpɔkpɔ, nyatoƒoetotowo gbɔ kpɔkpɔ kple nya siwo ku ɖe wò asi ŋu.
Dze egɔme kple nuŋlɔɖiwo, ɖo kpe wo dzi le ɖokuiwò si, lé ŋku ɖe alesi dɔwɔƒea wɔa eƒe ɖoɖowo ŋudɔe ŋu, eye nàwu kpɔɖeŋu ƒe nudɔdɔ si dzi wokpɔ ŋusẽ ɖo nu hafi nàdo ŋugbe ɣeyiɣi didi aɖe.
Ƒumeŋutinuwɔƒe tiatia nye afɔkudzikpɔkpɔ ŋuti nyametsotso. Nyayɔyɔ si bɔbɔ ate ŋu axɔ asi ne ɖaseɖigbalẽa ƒe lolome mesɔ kple nusi wowɔ o, dɔwɔnuwo mede blibo o, nuŋlɔɖiwo he ŋkɔ ŋɔŋlɔ ɖe megbe, alo womate ŋu aka ɖe wo gbugbɔgade eme o. Le ɣeyiɣi ma ke me la, nyatakakadzraɖoƒe si wowɔ nyuie alo adzɔnuwo ƒe xexlẽdzesi didi meɖo kpe edzi be adzɔnuwɔƒe ate ŋu awɔ ɖe asi si nèdi be yeakpɔ la ƒe nudidiwo gbɔ o.
Wotrɔ asi le mɔfiame sia ŋu na dukɔwo dome ƒumeŋuɖui mamalawo, nusiwo wotsɔ tso duta vɛ, kɔdzi ƒe nuƒlehawo kple ame ŋutɔ ƒe ŋkɔ ƒlelawo. Eƒoa nu tso nyabiase kple kpeɖodzi siwo hiã hafi nudzrala nada asi ɖe edzi ŋu. Mexɔ ɖe sedziwɔwɔ me toto, nyonyome me dzodzro, senyawo me toto alo dɔdaƒe ƒe dodokpɔ teƒe o.
Nuŋlɔɖi siwo nàbia hafi atsɔ nyayɔyɔwo asɔ kple wo nɔewo
Bia adzɔnuwɔƒe ɖesiaɖe si woɖo ɖe ŋkɔ kpui me be wòana kpeɖodzinu ma ke. Nubiabia si wowɔna ɖaa nana be tsɔtsɔ sɔ kple wo nɔewo nɔa bɔbɔe eye wòɖea afɔku si le dɔwɔƒe tiatia me dzi kpɔtɔna elabena etsɔ asitsatsa ŋuti nyatakaka siwo hea ame—gake mede blibo o—na.
| To nuto me | Kpeɖodzi si nàbia | Nusi dzi woaɖo kpee | Nuxlɔ̃amedzesi si bɔ |
|---|---|---|---|
| Dɔwɔƒea ƒe dzesideŋkɔ | Asitsatsa ƒe mɔɖegbalẽ, dɔwɔƒea ƒe adrɛs kple adzɔnuwɔƒea ŋuti nyatakakawo le se nu | Edze ƒã be kadodo le nubablawɔla, ewɔla kple ɖaseɖigbalẽxɔla dome | Wotsɔa asitsaha aɖe ɖoa ŋkume be eyae nye ewɔla le se nu numeɖeɖe aɖeke manɔmee |
| Dzɔdzɔmeŋutete ƒe ɖoɖo | ISO 13485 ƒe ɖaseɖigbalẽ si li fifia kple eƒe lolome | Amesi nae, eƒe nyonyome, adrɛs, dɔwɔnawo kple adzɔnuwo ƒe hatsotso siwo ŋu woƒo nu tsoe | Ðaseɖigbalẽa ƒe ɣeyiɣia wu enu alo eƒe lolome meku ɖe nusiwo wobia ŋu o |
| Asitsatsa ƒe mɔnukpɔkpɔ | Adzɔnuwo ƒe ŋkɔ ŋɔŋlɔ, mɔɖeɖe, ɖaseɖigbalẽwo alo gbeƒãɖeɖewo | Kpɔɖeŋu ŋkɔwo, asi si woɖo, ɖaseɖigbalẽ ƒe xexlẽdzesi kple nɔnɔme si li fifia | Wogblɔ tso dɔwɔƒea ƒe ŋkɔ dede agbalẽ me ŋu be enye mɔɖeɖe ɖe adzɔnu ɖesiaɖe ŋu |
| Nusiwo woate ŋu akpɔ | Kpɔɖeŋu nusiwo wotsɔ wɔe ƒe ɖaseɖigbalẽ, lot nuŋlɔɖi, mɔzɔla kple ŋkuléle ɖe nu ŋu ƒe nuŋlɔɖi | Nuŋlɔɖiwo doa ka kple nusiwo wotsɔ wɔe, nuwɔwɔ ƒe akpa kple nusi wowɔ vɔ | Nusiwo wotsɔ wɔa dɔe ƒe nɔnɔmetata si wozãna le mɔ vovovowo nu koe li |
| Dadaɖeanyi | Aɖaŋu si sɔ, mɔ̃ɖaŋu, dɔwɔwɔ, dzadzɛnyenye kple nubablɛ ƒe kpeɖodzi | Kpeɖodziawo ku ɖe kpɔɖeŋu kple ɖoɖo si wobia ŋu | Dodokpɔ ƒe kpukpuiwo ɖea kpɔɖeŋu xexlẽdzesiwo, mɔnuwo alo lɔlɔ̃ ɖe edzi ƒe dzidzenuwo ɖa |
| Nuzazãwo ƒe dɔwɔwɔ | Ŋutete ƒe nyagbɔgblɔ, ɣeyiɣi siwo woɖo ɖi kple nyatakaka siwo wotsɔ yi nyitsɔ laa | Ɣeyiɣi si woyɔ be woatsɔ awɔ dɔe la ɖea ŋutete ŋutɔŋutɔ kple nudzraɖoƒewo ƒe anyinɔnɔ fiana | Wogblɔ tso nudɔdɔ ɖesiaɖe ŋu be ate ŋu awɔ nu kpata evɔ nyatakaka siwo ɖo kpe edzi manɔmee |
| Nudzadzra megbe dziɖuɖu | Nyatoƒoetoto, CAPA, ŋudzɔnɔnɔ kple ŋkuɖoɖo nu dzi ƒe ɖoɖowo | Woɖe agbanɔamedziwo kple ɣeyiɣi siwo woatsɔ adzi ɖe edzi la me | Dɔwɔwɔ aɖeke si ŋu woŋlɔ nu tsoe meli le eɖoɖo ɖe amewo megbe o |
1Ðo kpe dɔwɔƒea ƒe dzesideŋkɔ le se nu kple akpa si wòwɔna le adzɔnuwo wɔwɔ me dzi
Gbã la, kpɔ amesi awɔ nusiwo wotsɔ dea lãme na ame, amesi tɔ aɖaŋu kple ŋkɔ dede agbalẽ me, amesi adze le dzesidenua dzi, kple amesi ade asi nubabla la te. 'Nudzrala,' 'dɔwɔƒe,' 'adzɔnu ƒe aƒetɔ' kple 'nuwɔla le se nu' menye dɔwɔƒe ɖeka le wo ɖokui si o.
Tsɔ dɔwɔƒea ƒe ŋkɔ kple adrɛs si woɖe fia le asitsatsa ƒe mɔɖegbalẽ, nyonyome-ɖoɖo ƒe ɖaseɖigbalẽ, adzɔnuwo ŋuti nuŋlɔɖiwo, nyayɔyɔ, ŋkɔ ƒe nutata kple gadzraɖoƒe ƒe gakɔnta sɔ kple wo nɔewo. Ne dɔwɔƒe vovovowoe le eme la, bia be woaŋlɔ numeɖeɖe tso woƒe akpa siwo wowɔna kple nubabla me ƒomedodo ŋu.
- Kpɔ adzɔnuwɔƒea ƒe adrɛs ŋutɔŋutɔ ɖa, ke menye nudzraƒea ƒe adrɛs ɖeɖeko o.
- Bia dɔ siwo wowɔna le aƒea me kple esiwo wotsɔ dea asi na ame bubuwo hã.
- Ðo kpe amesi kpɔa aɖaŋu ƒe tɔtrɔwo, mɔ̃ɖaŋu ŋuti nyatakakawo kple nyatoƒoetoto ŋuti numekukuwo dzi.
- Le dɔ siwo ame ŋutɔ ƒe ŋkɔ le gome la, de dzesi akpa si awɔ ŋkɔ ŋɔŋlɔ ɖe asi ɖesiaɖe me.
2Kpɔ egbɔ be nyonyome-ɖoɖo ƒe kekeme kple asi ƒe mɔɖeɖe ɖe adzɔnuwo koŋ ŋu
ISO 13485 nye atikewɔnuwo ƒe nyonyome dzikpɔkpɔ ƒe dzidzenu, gake ele be woato ɖaseɖigbalẽ aɖe me le nya siwo ƒo xlãe nu. Kpɔ dɔwɔƒe si le se nu, teƒea ƒe adrɛs, dɔwɔna siwo ŋu woxea fe ɖo, adzɔnuwo ƒe hatsotsowo, ŋkeke siwo dzi woɖe wo ɖe go kple esiwo ƒe nuwuwu, kple ɖaseɖigbalẽdɔwɔƒea ƒe nɔnɔme. Ðaseɖigbalẽ si sɔ nye gɔmedzedze vevi aɖe; menye nusi woatsɔ aɖo kpeɖodzi siwo ku ɖe adzɔnuwo koŋ ŋu teƒe o.
Le United States gome la, mègaxɔ 'FDA si woŋlɔ ŋkɔ na' alo 'FDA ƒe ɖaseɖigbalẽ' abe kpeɖodzi be woɖe mɔ̃ aɖe ɖa alo da asi ɖe edzi o. FDA gblɔ be dɔwɔƒea ƒe ŋkɔ ŋɔŋlɔ kple mɔ̃wo ƒe ŋkɔ ŋɔŋlɔ mefia be woda asi ɖe edzi, woɖe mɔ ɖe eŋu alo woɖe mɔ ɖe eŋu o. Bia atikeawo ƒe hatsotso si sɔ kple wo ɖoɖo ɖa do ŋgɔ na wo dzadzra ŋuti nyatakakawo, le afisi wòhiã le, eye nàɖo kpe edzi le FDA ƒe nyatakakadzraɖoƒe si sɔ.
Le Europa Dukɔwo ƒe Ðekawɔha gome la, lé ŋku ɖe akpa si adzɔnuwɔƒea wɔ le Sedede (EU) 2017/745, mɔ si sɔ si dzi woato akpɔe ɖa be wowɔ ɖeka kple wo nɔewo, gbeƒãɖeɖe be wowɔ ɖeka kple ɖaseɖigbalẽa ƒe lolome ŋu. Le afisi wòsɔ le la, ɖo kpe habɔbɔ si wona nyanya kple ɖaseɖigbalẽ ŋuti nyatakakawo dzi to Europa ƒe dɔwɔƒe siwo dziɖuɖua da asi ɖo abe EUDAMED ene dzi.
Mègada asi ɖe nudzrala aɖe dzi le logowo dzi o
ISO, CE kple FDA ƒe dzesi siwo le agbalẽ gbadza aɖe me menye kpeɖodzi si sɔ o. Ŋlɔ ɖaseɖigbalẽ alo xexlẽdzesi si tututu wotsɔ ɖo ɖa, sedzikpɔha si ŋu woke ɖo, adzɔnuwo ƒe ƒome, kpɔɖeŋu kple asi si woɖo taɖodzinu na, emegbe nàɖo kpe nu ɖesiaɖe dzi le eɖokui si.
Ðaseɖigbalẽ siwo XC Medico na ƒe kpɔɖeŋuwo
Nɔnɔmetata siwo le ete la nye nuŋlɔɖiwo ƒe kpɔɖeŋuwo hena ŋkuléle ɖe wo ŋu zi gbãtɔ. Hafi nudzrala nada asi ɖe edzi la, bia kɔpi siwo ƒe nyametsotso blibo fifia eye nàɖo kpe dɔwɔƒe si le se nu, teƒe si wowɔe le, ɖaseɖigbalẽa ƒe xexlẽdzesi, dɔwɔƒe si nae, ŋkeke siwo dzi woawɔ dɔ, dɔwɔna siwo ŋu woƒo nu tsoe kple adzɔnuwo ƒe lolome si sɔ.
TÜV SÜD CE ɖaseɖigbalẽ ƒe nuŋlɔɖi ƒe kpɔɖeŋu
TÜV SÜD ISO 13485 ɖaseɖigbalẽ ƒe nuŋlɔɖi ƒe kpɔɖeŋu
Spine FSC nuŋlɔɖi ƒe kpɔɖeŋu
ISO 13485 ɖaseɖigbalẽ ƒe nuŋlɔɖi ƒe kpɔɖeŋu
Woɖea nuŋlɔɖiwo ƒe nɔnɔmetatawo fiana hena numekuku ɖeɖeko eye mele be woabu wo be wonye kpeɖodzi be woɖe mɔ ɖe adzɔnu ɖesiaɖe ŋu le asi ɖesiaɖe me o.
3To raw-material kple production traceability me
Ƒumeŋutinu siwo wotsɔ dea ƒumeŋuɖui ƒeƒle bia nu geɖe wu be woaɖo kpe nusiwo ƒe dzeside aɖe dzi le agbalẽdzraɖoƒe aɖe ko. Bia tso ewɔla si be wòaɖe alesi woate ŋu akpɔ nusi wotsɔ de ame me si wowɔ vɔ to mɔ̃ɖaŋununya, dzoxɔxɔ alo anyigbadzidɔwɔwɔ, ŋkuléle ɖe nu ŋu kple nu xoxo siwo va ƒe nuŋlɔɖi siwo va la me afia.
Ele be traceability kpɔɖeŋu si ŋu viɖe le natsɔ nusiwo wowɔ vɔ ƒe akpa alo serial identifier aƒo ƒu kple raw-material ƒe ɖaseɖigbalẽ, production traveller, key process records kple serial inspection. Dodokpɔ kple dzidzenu siwo tututu woawɔ la nɔ te ɖe mɔ̃a, nusi wotsɔ wɔe, alesi woɖoe be woazãe kple asi dzi; ƒo asa na ɖaseɖigbalẽ si nye generic checklist zazã ɖe ƒome ɖesiaɖe si wotsɔ dea lãme na ame ŋu.
- Bia be woawɔ kpɔɖeŋu ƒe hatsotso ƒe nuŋlɔɖi si wogbugbɔ trɔ asi le na adzɔnu si sɔ kplii.
- Kpɔ alesi wode dzesi nusiwo mewɔ ɖeka o, woɖe wo ɖe vovo eye woɖo wo ɖe ɖoɖo nu.
- Bia alesi woate ŋu ake ɖe ɖoɖo tɔxɛ siwo wotsɔ de asi na ame bubuwo ŋui hã.
- Ðo kpe ɣeyiɣi didi si woléa nyonyome ŋuti nuŋlɔɖiwo ɖe asi na asi si ŋu nya ku ɖo la dzi.
XC Medico ƒe dutoƒo woate ŋu azã ƒunukpeƒetetedɔ ƒe nyonyomedzikpɔkpɔ ŋuti numedzodzro abe gɔmedzedze ene na numedzodzro, gake ele kokoko be nuƒlela nabia kpeɖodzi si ku ɖe nusi wowɔ kple akpa aɖe koŋ ŋu le dzedzeɣi.
4Dzro aɖaŋu ƒe kpeɖodzi, dɔwɔwɔ ƒe kpeɖodzi kple dodokpɔ me
Bia kpeɖodzi kawoe ɖo kpe atike si tututu nèɖo be yeaƒle dzi. Dodokpɔ ƒe nyatakaka na lolome, nu alo ɖoɖo si to vovo ate ŋu manye teƒenɔla o. Ele be adzɔnuwɔƒea nate ŋu aɖe alesi wotia ɖoɖo si wodo kpɔ kple alesi emetsonuwo wɔa dɔ le adzɔnuwo ƒe ƒomea katã me.
Le nusi wowɔ nu la, ŋkuléle ɖe nu ŋu ate ŋu anye aɖaŋunu siwo wotsɔ de eme, afɔkudzikpɔkpɔ, didime me toto, mɔ̃wo dodokpɔ, nugbagbewo ƒe ɖekawɔwɔ, dzadzɛnyenye, babla, dɔlékuiwutike alo dɔwɔwɔ tɔxɛ ƒe kpeɖodzinana. Ele be wò nyonyome kple ɖoɖowɔhawo naɖe nuŋlɔɖi siwo hiã na asi si ŋu nèɖo taɖodzinu ɖo kple wo zazã si woɖo be woazã la me.
Le dɔwɔƒea me toto me la, tsɔ ɖoɖo siwo woŋlɔ ɖi sɔ kple nusiwo wowɔ ŋutɔŋutɔ. XC Medico na dutoƒo nyatakaka tso eƒe... ƒumeŋuɖui ƒe atikewo wɔwɔ ƒe ɖoɖo ; ele be mamalawo nazã nyatakaka mawo atsɔ adzra agbalẽdzikpɔkpɔ ŋuti nyabiase siwo le tẽ wu ɖo tsɔ wu be woabu nyatakakadzraɖoƒe ƒe nuŋlɔɖi aɖe be enye agbalẽdzikpɔkpɔ ƒe kpeɖodzi.
5Da adzɔnuwo ƒe agbalẽdzraɖoƒe, dɔwɔnuwo kple ɖoɖoa ƒe blibonyenye kpɔ
Ne ɖoɖo siwo wò asisiwo hiã la de blibo, woŋlɔ wo ɖi ɣesiaɣi eye woate ŋu akpɔ wo ŋutɔŋutɔ ko hafi agbalẽdzraɖoƒe gbadza aɖe ɖea vi. To nusiwo wotsɔ dea ame me, dɔwɔnuwo, agbawo, nuɖazewo, akpa siwo woatsɔ awɔ dɔe, woƒe lolome ƒe didime kple nusiwo woatsɔ agbugbɔe ade eme abe ɖoɖo ɖeka ene.
- Kpe ɖe SKU siwo nye standard, siwo wowɔ ɖe ɖoɖo nu alo wole ɖeɖem kpɔtɔ vivivi dzi.
- Kpɔe ɖa be dɔwɔnuwo kple nusiwo wotsɔ dea lãme ƒe vovototowo sɔ kple ɖoɖo ɖeka si ŋu woŋlɔ nu tsoe hã.
- To dzesidede nu, mɔfiame siwo ku ɖe eŋudɔwɔwɔ kple nubablɛwo ƒe ɖoɖowɔwɔ me le asi nu.
- Bia alesi wogblɔa aɖaŋu ƒe tɔtrɔwo kple akpa siwo wodzudzɔ zazã hã.
- Kpɔe ɖa be woŋlɔ nya siwo sɔ kple wo nɔewo ɖe agbalẽ me eye woɖo seɖoƒe na ƒoƒo ɖekae siwo ŋu woda asi ɖo ko.
Mègaxɔ nya siwo keke ta abe 'ewɔ ɖeka kple ɖoɖowo katã' alo 'MRI dedie' ne womede dzesi mɔ̃ tɔxɛ aɖe kple kpeɖodzi siwo ɖo kpe edzi o. Ele be woada alesi wowɔ ɖeka kple MR ƒe dedienɔnɔ ŋuti nyatakakawo kpɔ le atike si tututu wowɔ kple nɔnɔme siwo woɖo be woawɔ ŋu.
6Kpɔ ewɔwɔ ƒe ŋutete, nudzraɖoƒewo kple nuwo ɖoɖoɖa dzi kpɔkpɔ ɖa
Ele be woada ŋutete kpɔ le wò nyagblɔɖi nu, ke menye abe dɔwɔƒe ƒe xexlẽdzesi si le eɖokui si ene o. Ma SKU tsakatsaka ŋutɔŋutɔ, nudɔdɔ zi gbɔ zi geɖe, tender ɖoɖowɔɖi kple taɖodzinu subɔsubɔ ƒe ɖoɖo. Emegbe bia tso adzɔnuwɔƒea si be wòaɖe ŋutete si li, aŋetu ƒe dɔwɔwɔwo, nudzraɖoƒewo ƒe ɖoɖo kple ɣeyiɣi si woatsɔ awɔ dɔe ƒe susuwo me.
Dzro vovototo si le nusiwo le nudzraɖoƒe, nusiwo wowɔna le ɖoɖo nu kple nusiwo wowɔ ɖe ɖoɖo nu dome. Bia alesi wokpɔa nu xoxowo ƒe anyimanɔmanɔ, dɔwɔwɔ siwo wotsɔ de asi na ame bubuwo, dɔwɔnuwo dzadzraɖo kple didi ƒe agbɔsɔsɔ si sɔ gbɔ wu gbɔe. Nyatakaka siwo wotsɔ ɖo nudɔdɔ siwo sɔ kple wo nɔewo gbɔ nyitsɔ laa ɖe game dzi la ɖea vi wu ŋugbedodo si wogblɔna le afisiafi be woaɖo wo ɖe wo kabakaba.
XC Medico ƒe implant supply-chain kple warehousing overview ɖɔ eƒe dutoƒo dɔwɔwɔ ƒe ɖoƒe. Ele be mamala nakplɔe ɖo kple ɣeyiɣi siwo li fifia ƒe nɔnɔmetata kple ɣeyiɣi siwo woŋlɔ ɖi na ɖoɖo siwo tututu ŋu wole nu ƒom tsoe.
7Na OEM/ODM, MOQ kple nunya-nunɔamesiwo ƒe nyawo me kɔ
Dɔ siwo wowɔna le ame ŋutɔ ƒe ŋkɔ me kple esiwo wowɔ ɖe ɖoɖo nu bia nyametsotso siwo ŋu asixɔxɔ ɖeka aɖeke meku ɖo o. Hafi nàda asi ɖe kpɔɖeŋuwo dzi la, ŋlɔ amesi tɔ nutatawo, dɔwɔnuwo, kpeɖodzinyatakakawo, nutata siwo wobla ɖe agba me kple ŋkɔ ŋɔŋlɔ siwo do tso eme. Ðe alesi wokpɔa nyatakaka ɣaɣlawo tae kple nenye be woate ŋu atsɔ aɖaŋuwo ana asisi bubuwo.
- Ma ame ŋutɔ ƒe dzeside si wozãna ɖaa ɖa tso atsyã ƒe tɔtrɔ vavãtɔ gbɔ.
- Ðe kpɔɖeŋu, kpeɖodzinana kple nuwɔwɔ-da asi ɖe edzi ƒe afɔɖeɖewo gɔme.
- Ŋlɔ nudɔdɔ ƒe agbɔsɔsɔ suetɔ ɖi to SKU kple ɖoɖo blibo nu.
- Lɔ̃ ɖe aɖaŋu-trɔtrɔ ŋuti nyatakaka kple gbugbɔgaɖoanyi ƒe agbanɔamedziwo dzi.
- Na dɔwɔnuwo ƒe aƒetɔ nyenye, anyigbamama ƒe sewo kple wo nu tsotso ƒe gomenɔamesiwo me nakɔ.
Ne èdi asitsatsa ŋuti numetoto si de to wu la, zã esia OEM wɔla ƒe veviedodonu si sɔ ƒe ɖaseɖigbalẽ kpe ɖe wò nyonyome kple senyawo me dzodzro ŋu.
8Da ŋkɔ ŋɔŋlɔ, dɔbiagbalẽvi kple mɔ̃ɖaŋu-nuŋlɔɖiwo ƒe kpekpeɖeŋu kpɔ
Adzɔnuwɔƒe ate ŋu awɔ nusiwo dzi woda asi ɖo eye wòaganye amesi mesɔ o kokoko ne eƒe nuŋlɔɖiwo meda asi ɖe ŋkɔ ŋɔŋlɔ alo dɔbiagbalẽviwo wɔwɔ le wò asi me dzi o. Wɔ nuŋlɔɖi ƒe matriki hafi nàwɔ asitsatsa ƒe nudɔdɔ gbãtɔ.
Ele be matriki la nade dzesi nuŋlɔɖi ɖesiaɖe si hiã, etɔ, gbegbɔgblɔ, ɖoɖo, tɔtrɔ, ŋkeke si wokpɔ mɔ be woatsɔe vɛ kple nya ɣaɣla ƒe nɔnɔme. Dzro alesi adzɔnuwɔƒea kpɔa nu yeyewo dzi ne ɖaseɖigbalẽ, ŋkɔ, mɔfiame, nɔnɔme alo aɖaŋu trɔ.
Bia agbalẽdzraɖoƒe si ku ɖe asi aɖe koŋ ŋu
Le esi teƒe be nàbia be, 'CE alo FDA le asiwòa?', tsɔ dukɔ si nèdi be yeakpɔ, adzɔnuwo ƒe ƒome kple kpɔɖeŋu ƒe xexlẽdzesi. Bia tso adzɔnuwɔƒea si be wòawɔ SKU ɖesiaɖe ƒe nɔnɔmetata ɖe sedede kple mɔ̃ɖaŋununya ƒe kpeɖodzi siwo li dzi. Na sedzikpɔla bibiwo nakpɔe ɖa be nuŋlɔɖiawo sɔ gbɔ na asi si nèɖo be yeaƒle.
9To nyatoƒoetotowo gbɔ kpɔkpɔ, CAPA kple ŋkuɖoɖonudzi ƒe dzadzraɖo me
Ele be nudzrala ƒe dzedze naxe nusiwo dzɔna le eɖoɖo ɖe amewo megbe. Bia alesi woxɔa nyatoƒoetotowo, wodaa wo kpɔna, kua wo me, wowɔa nu ɖe wo ŋu eye wotua wo hã. Ðo kpe alesi adzɔnuwɔƒea gblɔa nudzɔdzɔ siwo ŋu woate ŋu agblɔ nya le, agblemenuwɔnawo, ŋkuɖoɖonudzi kple ɖɔɖɔɖodɔwo na mamalawo kple ganyawo ŋuti dɔwɔƒe bubuwo dzi.
- Amekae nye nyatoƒoetoto kple ŋudzɔnɔnɔ ƒe kadodo vevitɔ?
- Nyatakaka kawoe hiã hafi woate ŋu adze numekuku gɔme?
- Aleke wokpɔa nusiwo wogbugbɔ tsɔ vɛ dzi hedoa wo kpɔna?
- Aleke woŋlɔa nusi gbɔ wòtso, CAPA kple dɔwɔwɔ nyuie ƒe dodokpɔwo ɖi?
- Aleke wodea dzesi lot kple asisi siwo ŋu wògblẽ nu le le gbeadzi afɔɖeɖe aɖe me?
Mègaɖo ŋu ɖe 'mɔ̃ɖaŋununya ƒe kpekpeɖeŋu' si womewɔ le ɖoɖo nu o ŋu be wòaxɔ ɖe asitsatsa megbe ɖoɖo siwo woŋlɔ ɖi kple ɖoɖowɔɖi ƒe agbanɔamedzi siwo woma eme kɔ la teƒe o.
10Wɔ kpɔɖeŋu nudɔdɔ kple nudzrala ƒe xexlẽdzesigbalẽvi si dzi wokpɔna
Kpɔɖeŋu nudɔdɔ doa nu geɖe kpɔ wu nusi wowɔ ƒe dzedzeme ko. Zãe nàtsɔ ada nyayɔyɔ ƒe nyateƒenyenye, nuŋlɔɖiwo dzi kpɔkpɔ, dzesideŋkɔ, babla, kadodo, ɣeyiɣi si woatsɔ awɔ dɔe, ŋkuléleɖenuŋu me tsonu kple nyabiasewo ŋuɖoɖo kpɔ. Ŋlɔ lɔlɔ̃ ɖe edzi ƒe dzidzenuwo ɖi hafi nàbia kpɔɖeŋua.
Zã dzidzenu siwo woda kpekpeme na la ke tsɔ de dzesi adzɔnuwɔƒe ɖesiaɖe. Dzesidegbalẽvi si bɔ ate ŋu anye sedede ƒe sɔsɔ, nyonyome ƒe kpeɖodzi, didi, mɔ̃ɖaŋununya ƒe ŋutete, ɖoɖoa ƒe blibonyenye, nuzazãwo ƒe kakaɖedzi, nuŋlɔɖiwo, asitsatsa ŋuti nyawo kple kpekpeɖeŋu. Bu asixɔxɔ be enye nu ɖeka tsɔ wu be nàbu eŋu be enye nusi ƒo ɖesiaɖe ta.
| Ƒomedodo Kpekpeme | si wodo ɖa | Kpɔɖeŋu dzesibiabia |
|---|---|---|
| Sedede kple nyonyome-ɖoɖo ƒe sɔsɔ | 25% . | Ðe kpeɖodzi siwo ŋu woɖo kpee la ku ɖe dɔwɔƒe si le se nu, teƒea, adzɔnuwo kple asi si woɖo taɖodzinu na ŋua? |
| Traceability kple kpeɖodzinana | 20% . | Ðe nudzrala la ate ŋu atsɔ adzɔnuwo ƒe nyawo asɔ kple nuŋlɔɖi siwo dzi wokpɔna? |
| Nusi wowɔ kple dɔwɔnu ƒe blibonyenye | 15% . | Ðe ɖoɖo si wobia la de blibo, woŋlɔe ɖi eye woate ŋu ado alɔea? |
| Ŋutete kple eɖoɖo | 15% . | Ðe nyatakaka siwo li fifia ɖo kpe ŋutete, nudzraɖoƒe kple ɣeyiɣi si woatsɔ awɔ dɔe ƒe nyawo dzia? |
| Nuŋlɔɖiwo kple kpekpeɖeŋunana le asitsatsa megbe | 15% . | Ðe nudzrala ate ŋu ado alɔ ŋkɔ ŋɔŋlɔ, dɔbiagbalẽviwo, nyatoƒoetotowo kple tɔtrɔwo dzi kpɔkpɔa? |
| Asitsatsa ƒe nɔnɔme | 10% . | Ðe asixɔxɔ, MOQ, fexexe, IP kple anyigbamama ƒe nyawo li tegbeea? |
Trɔ asi le kpekpemeawo ŋu na wò asi kple adzɔnuwo ƒe afɔku. Ele be woabu ɖoɖowɔwɔ, nyonyome alo didi ƒe kpododonu vevi ɖesiaɖe abe agbo ene, ke menye be woatsɔ asi bɔbɔe alo dzesi gã aɖe axe fe ɖe eta le teƒe bubu o.
Aflaga dzĩ siwo bɔ ne wole atikewɔƒe tiam
Nya siwo wogblɔna siwo ŋu kekeme mele o
Adzɔha la gblɔ be 'FDA, CE kple ISO ƒe ɖaseɖigbalẽ' gake mateŋu atsɔ nya la aƒo ƒu kple sedzikpɔha, adzɔnu, kpɔɖeŋu kple asi o.
Nuŋlɔɖi siwo ŋu womate ŋu aɖo kpee o
Ðaseɖigbalẽ ƒe xexlẽdzesiwo, dɔwɔƒe siwo naa wo, ŋkekewo alo nusiwo ŋu woxe fe ɖo la bu, womewɔ ɖeka o alo womeli hena kpeɖodzi le wo ɖokui si o.
Ga home do ŋgɔ na nudidiwo
Wotsɔa ga home sesẽ aɖe naa hafi adzɔnuwɔƒea ɖoa kpe adzɔnuwo ƒe ɖoɖowɔwɔ, woƒe babla, nuŋlɔɖiwo kple ŋkɔ ŋɔŋlɔ ƒe hiahiãwo dzi.
Dodokpɔ ŋuti nyatakaka siwo wozãna le mɔ vovovowo nu
Nyatakakawo medea dzesi kpɔɖeŋu si wodo kpɔ, ɖoɖo, mɔnu, lɔlɔ̃ ɖe edzi ƒe dzidzenuwo alo kadodo si le adzɔnu si wobia la dome o.
Adzɔnuwɔƒea ƒe ŋkɔ si me mekɔ o
Ŋkɔ siwo le nubabla la, ɖaseɖigbalẽa, ŋkɔdzesi, gaxɔgbalẽvi kple gadzraɖoƒe ƒe gakɔnta dzi to vovo numeɖeɖe si woŋlɔ ɖi manɔmee.
Asitsatsa megbe ƒe ɖoɖo aɖeke meli o
Kpekpeɖeŋu nɔ te ɖe ame ɖekaɖekawo ƒe nudzadzra ƒe kadodowo dzi tsɔ wu be woanɔ te ɖe nyatoƒoetoto si woŋlɔ ɖi, CAPA, ŋudzɔnɔnɔ kple ŋkuɖoɖo nu dzi ƒe ɖoɖowo dzi.
Alesi woatsɔ XC Medico asɔ kple dɔwɔƒe bubuwo
Wɔ ɖaseɖigbalẽ ma ke ŋudɔ na XC Medico kple adzɔnuwɔƒe bubu ɖesiaɖe si woɖo ɖe ŋkɔ kpui me. Dutoƒo dɔwɔƒe, nyonyomedzikpɔkpɔ kple nuzazãwo ƒe kɔsɔkɔsɔ ƒe axawo ate ŋu akpe ɖe ŋuwò nàdzra nyabiasewo ɖo, gake ele be woatu nudzralawo ƒe mɔɖeɖe ɖe nuŋlɔɖi siwo li fifia kple kpeɖodzi siwo ku ɖe wò adzɔnuwo kple asi ŋu dzi.
Afɔɖeɖe si kplɔe ɖo si wɔa dɔe nye be nàdzra wò taɖodzinu-dukɔ ƒe xexlẽdzesi ɖo, adzɔnuwo ƒe ɖoɖo siwo hiã, nudɔdɔ ƒe ɖoɖo si wobu, OEM ƒe nudidiwo kple nuŋlɔɖiwo ƒe matriki. Bia tso adzɔnuwɔƒe ɖesiaɖe si be wòaɖo eŋu le ɖoɖo ma ke nu. Esia naa nuŋlɔɖi si sɔ kple wo nɔewo le nyonyome, ɖoɖowɔwɔ kple asitsatsa me toto ŋu.
XC Medico dɔwɔƒe kple adzɔnuwo wɔwɔ ŋuti nyatakaka. Zã videoa nàtsɔ adzra nyabiase siwo akplɔe ɖo ɖo; wu nudzrala ƒe mɔɖeɖe nu to agbalẽ siwo dzi wokpɔna fifia kple agbalẽdzikpɔkpɔ ƒe kpeɖodziwo zazã me.
Ne wò habɔbɔa le nudzrala aɖe si li xoxo ɖɔlim la, ke lé ŋku ɖe dɔwɔwɔ ƒe afɔku siwo ŋu woƒo nu tsoe le mɔfiame si nye... ƒumeŋuɖui ƒe atikewɔlawo ƒe tɔtrɔ evɔ womagblẽ wo mama me o.
Nya siwo wobiaa amewo enuenu
Ðaseɖigbalẽ kawoe wòle be ƒumeŋuɖuiwɔƒe nanɔ esi?
Ŋuɖoɖoa nɔ te ɖe nusi wowɔ kple asi si woɖo taɖodzinu na dzi. ISO 13485 nye nyonyomedzikpɔkpɔ ƒe dzidzenu si dzi woda asi ɖo le afisiafi na atikewɔnuwo ŋuti habɔbɔwo, gake ele be nuƒlelawo nato sedede ƒe kpeɖodzi siwo ku ɖe adzɔnuwo koŋ ŋu hã me. Kpɔ ɖaseɖigbalẽa ƒe lolome, teƒea, dɔwɔƒe si le se nu, adzɔnuwo ƒe ƒome, nɔnɔme si li fifia kple asitsatsa ƒe nudidi siwo sɔ la ɖa.
Ðe FDA ƒe ŋkɔ dede agbalẽ me fia be woda asi ɖe nusi wotsɔ dea ame me dzia?
Ao, FDA gblɔ be dɔwɔƒea ƒe ŋkɔ ŋɔŋlɔ kple mɔ̃wo ƒe ŋkɔ ŋɔŋlɔ mefia be woda asi ɖe dɔwɔƒea alo eƒe mɔ̃wo dzi, woɖe mɔ ɖe wo ŋu alo ɖe mɔ ɖe wo ŋu o. Le afisiwo wòhiã be woalé ŋku ɖe mɔ̃ aɖe ŋu do ŋgɔ na edzadzra la, kpɔ mɔɖeɖe, mɔɖeɖe alo mɔɖeɖe bubu si sɔ la ɖa ɖe vovo.
Aleke mamala ate ŋu aɖo kpe ISO 13485 ƒe ɖaseɖigbalẽ dzi?
Dzro ɖaseɖigbalẽa ƒe xexlẽdzesi, dɔwɔƒe si le se nu, teƒea ƒe adrɛs, dɔwɔna siwo ŋu woke ɖo, adzɔnuwo ƒe lolome, ɖaseɖigbalẽa ƒe habɔbɔ kple ŋkeke siwo dzi woawɔ dɔa me. Ðo kpe ɖaseɖigbalẽa dzi kple dɔwɔƒe si naa ɖaseɖigbalẽa alo naa ɖaseɖigbalẽa le afisi wòanya wɔ le, eye nàkpɔe ɖa be wozã nyonyome ƒe ɖoɖoa le dɔwɔwɔ me le nuŋlɔɖiwo me toto alo agbalẽdzikpɔkpɔ me.
Nuŋlɔɖi kawo ŋue wòle be woalé ŋku ɖo hafi awɔ nudɔdɔ?
Kpeɖodzi siwo bɔ dometɔ aɖewoe nye dɔwɔƒea kple adzɔnuwɔƒea ŋuti nyatakakawo, ISO 13485 ƒe lolome, asi ŋuti nuŋlɔɖi siwo ku ɖe adzɔnuwo koŋ ŋu, nu kple batch traceability ƒe kpɔɖeŋuwo, kpeɖodzi alo dodokpɔ ƒe kpeɖodzi siwo sɔ, dzesidede, mɔfiamewo, nuzazã ƒe ɖoɖowo, nyatoƒoetoto ƒe ɖoɖowo kple tɔtrɔwo dzi kpɔkpɔ ƒe agbanɔamedziwo. Ele be dɔwɔla bibi siwo bi ɖe nyonyome kple sedziwɔwɔ me naɖo xexlẽdzesi si tututu woaŋlɔ.
Vovototo kae le atike si wotsɔ dea lãme na ame ƒe dɔwɔƒe kple amesi naa ame dome?
Adzɔnuwɔƒe aɖe wɔa adzɔnuwo wɔwɔ ƒe dɔwɔnawo alo kpɔa wo dzi eye ate ŋu axɔ aɖaŋuwɔwɔ kple ɖoɖowɔwɔ ƒe agbanɔamedziwo hã. Nudzrala ate ŋu anye adzɔnuwɔƒe, adzɔnu ƒe ŋkɔ tɔ, numamãla alo asitsahabɔbɔ. Ele be nuƒlelawo nade dzesi akpa si dɔwɔƒe ɖesiaɖe wɔ si woŋlɔ ɖi tsɔ wu be woaɖo ŋu ɖe asitsatsa ŋuti nuŋlɔɖia ɖeɖeko ŋu.
Ðe wòle be asixɔxɔ nanye nu vevitɔ si dzi woanɔ te ɖo ne wole adzɔnuwɔƒe tiama?
Ao, ele be woada asi kpɔ ɖekae kple sedede ƒe sɔsɔ, nyonyome ƒe kpeɖodzi, alesi woate ŋu akpɔe, adzɔnuwo ƒe blibonyenye, ŋutete, kakaɖedzi le wo tsɔtsɔ yi na amewo, nuŋlɔɖiwo, asidede megbe kpekpeɖeŋu kple nubabla ƒe ɖoɖowo ŋu. Ga home si bɔbɔ le gɔmedzedzea me ate ŋu ahe ŋkɔ ŋɔŋlɔ, nudzraɖoƒe alo nyonyome ƒe gazazã geɖe vɛ emegbe.
Bia adzɔnuwɔƒea ƒe kpeɖodzigbalẽvi
Ma wò asi si nèɖo taɖodzinu na, adzɔnuwo ƒe hatsotso, nudɔdɔ ƒe ɖoɖo si wokpɔ mɔ na kple OEM ƒe nudidiwo. Bia nuŋlɔɖi ƒe agbalẽvi si me wò nyonyome, ɖoɖowɔwɔ kple nuƒle ƒe ƒuƒoƒowo ate ŋu alé ŋku ɖe eŋu hafi aʋu ayi kpɔɖeŋuwo alo asitsatsa ƒe nudɔdɔ aɖe gbɔ.
Te ɖe XC Medico ŋuSedziwɔwɔ ƒe nyatakaka siwo dziɖuɖua ɖo
- ISO 13485:2016 — Atikewɔnuwo ƒe nyonyome-dzikpɔkpɔ ƒe ɖoɖowo
- United States FDA — Dɔwɔɖoɖo si Kpɔa Dɔwɔnawo ƒe Nyonyome Gbɔ ƒe Sedede
- US FDA — FDA ƒe ŋkɔ ŋɔŋlɔ, ɖaseɖigbalẽ, mɔɖeɖe kple mɔɖeɖe ɖe eŋu me
- Europa Dɔwɔha — Atikewɔwɔ-mɔ̃wo ƒe ganyawo ŋuti dɔwɔƒewo
- Europa Dɔwɔha — EUDAMED ƒe nyatakaka bliboa
Dɔnyala ƒe zazã ŋuti nyatakaka: Woɖo nyati sia be wòado alɔ asitsalawo ƒe nudzralawo ƒe veviedodonu si sɔ. Menye atikewɔƒe ƒe aɖaŋuɖoɖo, senyawo ŋuti aɖaŋuɖoɖo alo nyametsotso be woɖe mɔ ɖe atike aɖe koŋ ŋu na asi aɖe koŋ o. Sedede kple nyonyome ƒe nudidiwo toa vovo le mɔ̃a, alesi woɖoe be woazãe kple ʋɔnudrɔ̃ƒe ƒe ŋusẽ nu; bia gbe eŋutinunyala bibiwo hafi awɔ nyametsotso siwo ada asi ɖe edzi alo aƒle nu.
