2026 jatebɔla gafe | Kolotugudaw ka furakɛlikɛlaw ka ɲɔgɔn sangali
o Kolotugudaw feerela min bɛ sanfɛ, tɛ a yɛrɛma ka kɛ baarakɛyɔrɔba ye. O ye feerekɛla ye min ka fɛn dilannenw hakɛ yamaruyalen, a ka baarakɛcogo misali, a ka sɛbɛnw, a ka fɛnmarataw dɛmɛni ani a ka jagokɛcogo bɛ bɛn i ka sugu ma. Nin gafe in bɛ tɔgɔ 12 sigilenw suma ɲɔgɔn na ni baarakɛcogo sɔrɔcogo ye, o kɔfɛ, a bɛ jatebɔlaw jira cogo min na u bɛ se ka lisi surun dɔ jɔ min bɛ se ka lafasa.
San 2026 kɔnɔ, kolotugudaw furakɛli ɲɛmɔgɔba jumɛnw de ye?
Kolotugudaw feerelaw minnu bɛ jateminɛ tuma caman na, olu ye DePuy Synthes, Stryker, Zimmer Biomet, Smith+Nephew, Enovis, Medtronic, Globus Medical, Orthofix, Alphatec, Arthrex, CONMED ani XC Medico ye. Nka, nin ye sɛbɛnnikɛlaw ka ɲɔgɔndan ye, a tɛ sɔrɔ jatebɔ ye min sɛgɛsɛgɛra walima k’a fɔ ko tɔn bɛɛ bɛ ɲɔgɔn sɔrɔ bɛnkansɛbɛn kelen na.
Fɛɛrɛbɔla ŋanaw bɛ se ka bɛn dɔgɔtɔrɔsow ma minnu bɛ taabolo laminiko sigilenw ɲini. Kɛrɛnkɛrɛnnenya la, fɛn dilannikɛlaw bɛ se ka barika sɔrɔ ni feerekɛla mago bɛ dunuya la kɔkolo walima farikoloɲɛnajɛ furakɛli la. OEM/ODM dilannikɛla min ɲɛsinnen bɛ jagokɛyɔrɔw ma, o bɛ se ka kɛ ko a nafa ka bon kosɛbɛ ni wajibi ye mɔgɔ kelen ka taamasiyɛn ye, minɛn minnu bɛ se ka labɛn, katalogu sɔrɔli ka bon ani fɛn dilanni kumaɲɔgɔnya tilennen.
Nin gafe in kalancogo : sosiyete ka yamaruya kulu kelen-kelen bɛɛ kɔnɔ, o tɛ baarakɛcogo jate ye. Fɛn dilannenw sɔrɔli, sariya siratigɛ la, taamasiyɛn minnu yamaruyara, sariyaw cogoya ani u tilatilali labɛnw tɛ kelen ye jamana kelen-kelen bɛɛ la, wa u bɛ se ka Changé. Aw bɛ u bɛɛ sɛgɛsɛgɛ sani aw ka sanni kɛ.
Nin kolotugudaw dilanbagaw ka sangaɲɔgɔnma in jɔra cogo min na
Barokun fɔlɔ ye sosiyetew jate bɔ 1 la ka se 12 ma k’a sɔrɔ a ma jatedenw bɔ minnu bɛ se ka suma ɲɔgɔn ma walima jatebɔ fɛɛrɛ dɔ. O bɛ jatebɔ dɔ Dabɔ min tɛ dɛmɛn. Nin bɔko kura in bɛ feerekɛlaw kuluw kuluw ka kɛɲɛ n’u ka sɔrɔcogo baarakɛcogo ye min bɛ bɛn kosɛbɛ, wa a bɛ ɲininkali duuru waleya minnu bɛ bɛn ɲɔgɔn ma.
Olu ye ɲɔgɔndan filɛriw ye, foroba jatew tɛ. Sannikɛlaw minnu mago bɛ jatebɔ girinman na, olu bɛ se ka baara kɛ ni danfaralan ye san 2026 kolotugudaw feerelaw ka jateminɛ hukumu dafalen . Ni ɲɛ fila ninnu danfaralen don, o fana bɛ daɲɛ kolomaw ɲɔgɔndan bali: nin ɲɛ in bɛ tɔnw suma ɲɔgɔn na, ka sɔrɔ jateminɛ gafe bɛ seko ni dɔnko ni jatebɔ ɲɛfɔ.
Mun na san 2026 nafa ka bon : FDA ka jogoɲumanya ɲɛnabɔli sariyasun daminɛna ka baara kɛ san 2026 feburuyekalo tile 2. UE kɔnɔ, EUDAMED modulu naani fɔlɔw kɛra wajibi ye kabini mɛkalo tile 28 san 2026. Ameriki ni UE sannikɛlaw ka kan ka QMS sisan, minɛnw-dantigɛliw ani sɔrɔko-baarakɛlaw ka daliluw don feerekɛlaw ka setigiya la.
Kolotugudaw dilanbagaw ni u bɛ tali kɛ sannikɛlaw ka baarakɛcogo la
| Supplier | Comparison group | Portofeuille prominent focus | Typical shortlist use case | Sɛgɛsɛgɛli sani sugandili ka kɛ |
|---|---|---|---|---|
| DePuy Synthes ka baara | Catégorie caman bɛ yen | Joli seginni, joginda, kɔkolo ani seko ni dɔnko fɛɛrɛw | Dɔgɔtɔrɔsobaw walima taabolo porogaramuw minnu bɛ kɛ ni fɛɛrɛ ye | Sisan bɛnkansɛbɛn, jamana ka portfolio ani kanal sɔrɔli |
| Stryker (Sɔrɔdasi) ye | Catégorie caman bɛ yen | Joli caman cili, joginda, farikoloɲɛnajɛ furakɛli, kɔkolo ani a ɲɔgɔnnaw | Taabolo laminikoba ni dɔgɔtɔrɔsow ka sariyasun | Sigida portifaliw, minɛnw jɔyɔrɔw ani porogaramu musaka bɛɛ lajɛlen |
| Zimmer Biomet ye baara kɛ | Catégorie caman bɛ yen | Kɔnɔbara, gɛnɛgɛnɛ, kamankun, a dakunw ani a ɲɔgɔnna fɛɛrɛw | Dɔgɔtɔrɔsow portifaliw minnu sinsinnen bɛ jɔli kura kan | Taabolo kɛrɛnkɛrɛnnenw sɔrɔli, setiw, baarakɛcogo ani kanal sariyaw |
| Smith+N balimakɛ denkɛ | Catégorie caman bɛ yen | Spor furakɛli, koloci ani joginda furakɛli ɲɛtaa | Spor furakɛli, segin-ka-bɔnye ani ASC-oriented accounts | Kategori juguya ani dɛmɛ jamana laɲininen kɔnɔ |
| Enovis ye baara kɛ | Catégorie caman bɛ yen | Opereli min bɛ kɛ ka mɔgɔ labɛn kokura, sen ni senkɔni, senkɔniw ni senkɔniw labɛnni ani u labɛnni | Extremities, reconstruction ani continuum-of-care portfoliow | Marka, katalogu, sariyasunba ani marabolo tilali modɛli min bɛ tali kɛ o la |
| Medtronic (Medtronic) ye | Kɔkolo kɔkolo | Kɔkolo doncogo, biologics, navigation, imagerie ani robotique | Kɔkolo porogaramu minnu bɛ se ka kɛ ni fɛɛrɛ kuraw ye | Taamaʃyɛnw, sistɛmu bolodalenw ani sigida dɛmɛni |
| Globus Dɔgɔtɔrɔso | Kɔkolo kɔkolo | Farikolo ni kolotugudaw furakɛli ni kɔkolo barikama ani seko ni dɔnko-fɛɛrɛ sɔrɔli | Baarakɛcogo minnu sinsinnen bɛ kɔkolo kan ani minnu bɛ se ka kɛ ni fɛɛrɛ kuraw ye | Jamana ka portfolio, jɛ-ka-baara cogoya ani baarakɛcogo seko |
| Orthofix (Orthofix) ye | Kɔkolo kɔkolo | Kɔkolo, koloci ani koloci furakɛli | Kɔkolo ni kolotugudaw mago gɛlɛnw | Fɛn dilannenw hakɛ, kalan, minɛnw ani marabolow sɔrɔli |
| Alfatɛki | Kɔkolo kɔkolo | Kɔnɔbara basigilen fɛnw doncogo, taabolo furakɛcogo ani kunnafoniko | Porogaramu kɛrɛnkɛrɛnnenw minnu bɛ kɛ kɔkolo la | Jagokɛlaw ka dakunw ni dɛmɛni suguya jɔnjɔnw kɔkan |
| Artɛrɛx (Arthrex) ye | Spor fura | Spor furakɛli, joli-sira-funu, joli-sira-funu ani kalan | Spor furakɛli ani opereli taama-taama porogaramuw | Sigida kanal modɛli, kalan ani kulu sɔrɔli |
| CONMED (KƆRƆBƆLI). | Spor fura / OR | Kolow ni opereli fɛɛrɛw, farikoloɲɛnajɛ furakɛli baarakɛminɛnw fana sen bɛ o la | OR-centré ani arthroscopie-related portfolios | Implant versus capital/tool scope ani baarakɛcogo wajibiyalenw |
| XC Medico ye baara kɛ | OEM / portfolio belebeleba | Jogin, kɔkolo, kolotugudaw, farikoloɲɛnajɛ furaw ani minɛnw | Distributeur, privé-label ani configurable portfolio porozew | Fɛn dilannenw ka yamaruya, poroze hakɛ, tiɲɛni ani fɛnw dicogo daliluw |
Duniya kɔnɔ kolotugudaw dilanbagaw ka catégorie caman
O jɛkuluw bɛ portifaliw di minnu ka bon walima minnu bɛ ɲɔgɔn dafa, wa a ka c’a la, u bɛ jateminɛ kɛ dɔgɔtɔrɔso porogaramuw labɛncogo ɲumanw na. U ka sɛgɛsɛgɛli bɛ se ka dɛmɛ don sigida sigilenw ma, nka jatebɔlaw ka kan ka a jira hali bi ni lajɛ bɛ se ka kɛ ani ni kulu wajibiyalen bɛ di sigida la.
DePuy Synthes
- Mun na a bɛ don lisi surun dɔ la
- Kolotugudaw ka kɛnɛyako dafalen ani taabolo sigilenw suguyabaw kɔnɔ.
- Typical fit
- Dɔgɔtɔrɔso rezow ni sannikɛlaw ka fɛɛrɛbɔ minnu bɛ kɛnɛyaso ekosisɛti sigilenw bila jɔyɔrɔ fɔlɔ la.
- Fɛn min ka kan ka sɛgɛsɛgɛ
- Johnson & Johnson y’a jira ko a b’a fɛ san 2025 ɔkutɔburukalo la k’a ka koloci jago faranfasi ka kɛ DePuy Synthes ye. Sariya ni bɛnkansɛbɛnw sigicogo min bɛ sen na sisan, jamana ka lasecogo ani a tilabaga ka se sɔrɔli sɛgɛsɛgɛ sanni waati.
Stryker
- Mun na a bɛ don lisi surun dɔ kɔnɔ
- Kolotugudaw furakɛli bolodalenba min bɛ kolotugudaw cili, joginda ni farikolo yɔrɔw, farikoloɲɛnajɛ furakɛli ani taabolo fɛɛrɛ wɛrɛw la.
- Typical fit
- Dɔgɔtɔrɔso porogaramu minnu bɛ fɛnw, minɛnw ani fɛɛrɛ minnu bɛ tali kɛ o la, olu ɲini sigida lamini na.
- Fɛn min ka kan ka sɛgɛsɛgɛ
- Sigida ka bolomafara tigitigi, kapitali-minɛnw walima minɛnw tali, kalan kɛcogo, baarakɛcogo sariyaw ani waleyali musaka bɛɛ lajɛlen dafa.
Zimmer Biomet
- Mun na a bɛ don lisi surun dɔ kɔnɔ
- Dɔnniya barikama kolotugudaw labɛnni na ni fɛɛrɛw ni fɛɛrɛw ye minnu bɛ tali kɛ taabolo kɛrɛnkɛrɛnnenw na.
- Typical fit
- Jagokɛlaw ni dɔgɔtɔrɔso jatew tun sinsinnen bɛ kɔkili, gɛnɛgɛnɛ, kamankun ani o ɲɔgɔnna jɔli porogaramuw kan.
- Fɛn minnu ka kan ka sɛgɛsɛgɛ
- Segin taabolo kɛrɛnkɛrɛnnenw jatebɔsɛbɛn kan, sigida minɛnw sigicogo sɔrɔli, u falenni, kalan ani bɛnkansɛbɛnw wajibiyalenw.
Smith+Nephew
- Mun na a bɛ don lisi surun dɔ kɔnɔ
- Fɛn minnu bɛ dɔn, olu ye farikoloɲɛnajɛ furakɛli ni kolotugudaw furakɛli ye, minnu bɛ dɛmɛ ni taabolo nafolo ye.
- Typical fit
- Spor furakɛli, jɔli kokura ani opereli taama-taama yɔrɔw portifaliw yɔrɔ minnu bɛ bɛn sigida la.
- Fɛn minnu ka kan ka sɛgɛsɛgɛ
- Aw ye a sɛgɛsɛgɛ ko kuluw, sigida minnu, kalan nafolo ani tilali labɛn minnu bɛ jamana laɲinitaw kɔnɔ.
Enovis
- Mun na a bɛ don lisi surun dɔ kɔnɔ
- A ka taamasiyɛnw portfolio bɛ opereli ni opereli tɛ kolotugudaw furakɛli fɛɛrɛw la, i n’a fɔ u jɔli kokura ani a dakunw.
- Typical fit
- Sannikɛlaw ka so jɔli suguya juguya ka tɛmɛn dakunw kan, jɔli kokura, bracing walima rehabilitation.
- Fɛn min ka kan ka sɛgɛsɛgɛ
- Aw ye Enovis taamasiyɛn ni sariya jɛkulu min ɲɛsinnen don o ma, o dɔn, o kɔfɛ, aw bɛ marabolo ka gafesɛbɛn min bɛ sen na sisan, o kanal modɛli ani dɛmɛjɛkulu sɛgɛsɛgɛ.
Furakɛlaw minnu ɲɛsinnen bɛ kɔkolo ma walima minnu barika ka bon kɔkolo la
A ka c’a la, kɔkolo sanni bɛ fɛnw fara ɲɔgɔn kan ni minɛn kɛrɛnkɛrɛnnenw ye, biologikiw, navigatiɔn, ja lajɛ, robotiki walima kunnafonidilanw. Aw bɛ taabolo baarakɛcogo dafalen suma, aw kana a doncogo sɔngɔ dɔrɔn suma.
Medtronic
- Mun na a bɛ don lisi surun dɔ kɔnɔ
- A ka kɔkolo ni kolotugudaw furakɛli la, o ye fɛnw doncogo ye, kolotuguda furaw ani seko ni dɔnko fɛɛrɛw.
- Typical fit
- Dɔgɔtɔrɔso minnu bɛ kɔkolo porogaramuba dɔ jateminɛ, min bɛ se ka kɛ ni fɛɛrɛ kuraw ye.
- Fɛn minnu ka kan ka sɛgɛsɛgɛ
- Aw ye fɛn dilannenw jiracogo, u bɛnkan, u ka minɛnw ni porogaramuw danfaralenw lajɛ, u ka kalan ni u ka baarakɛcogo bɛ sɔrɔ yɔrɔ la sugu la.
Globus Medical
- Mun na a bɛ don lisi surun dɔ kɔnɔ
- Farikolo ni kolotugudaw fɛɛrɛbɔ baarakɛda min ka kɔkolo ni seko ni dɔnko dilancogo caman bɛ a bolo.
- Typical fit
- Sannikɛlaw minnu sinsinnen bɛ kɔkolo kan, olu bɛ fɛnw doncogo jateminɛ ɲɔgɔn fɛ ni baarakɛcogo ye min bɛ se ka kɛ ni fɛɛrɛ kuraw ye.
- Fɛn minnu ka kan ka sɛgɛsɛgɛ
- Aw ye sisan fɛn dilannenw marayɔrɔ, mara jagokɛlaw ka dantigɛli, fɛɛrɛbɔ, minɛnw labɛncogo ani baarakɛminɛnw jaabi, olu sinsin.
Orthofix
- Mun na a bɛ don lisi surun dɔ kɔnɔ
- Fɛn minnu bɛ kɛ, olu ye kɔkolo, koloci ani koloci furakɛli ye.
- Typical fit
- Porogaramu kɛrɛnkɛrɛnnen minnu bɛ kɔkolo juguya walima kolotugudaw furakɛcogo gɛlɛn sugandilenw de wajibiya.
- Fɛn min ka kan ka sɛgɛsɛgɛ
- Aw ye fɛn dilannenw hakɛ tigitigi sɛgɛsɛgɛ, sariya dilabaga, sigida ka sɔnniw, kalan, minɛnw dɛmɛni ani marabolow sɔrɔli.
Alphatec
- Mun na a bɛ don lisi surun dɔ kɔnɔ
- Baarakɛda min ɲɛsinnen bɛ kɔkolo ma, ni taabolo ɲɛnabɔcogo ni dɛmɛ fɛɛrɛw ye.
- Typical fit
- Cokolon porogaramu kɛrɛnkɛrɛnnenw yɔrɔ minnu na, furakɛli kuntaalajan dafalen de ye fɔlɔ ye.
- Fɛn minnu ka kan ka sɛgɛsɛgɛ
- Aw ye yamaruya, sɔrɔli, feereli ani kɛnɛyaso dafalenw, minɛnw, fɛnmarataw ani baara dafa yɔrɔ laɲininen na.
Spor furakɛli ni opereli-so feerelaw
Spor furaw ni OR feerelaw bɛ se ka sugandi ka kɛɲɛ ni taabolo juguya ye, joli-sira-funu-minɛnw, minɛnw ni kalan sanni ka kɛ joginda dafalen ye, kɔkolo ni kolotugudaw labɛncogo kura bonya.
Arthrex
- Mun na a bɛ don lisi surun dɔ la
- Jɛɲɔgɔnya barikama ni farikoloɲɛnajɛ furakɛli, jolilabanaw, minɛnw ani furakɛli kalanni ye.
- Typical fit
- Spor furakɛli ani opereli taama-taama porogaramuw minnu bɛ taabolo juguya ɲini.
- Fɛn minnu ka kan ka sɛgɛsɛgɛ
- Aw ye fɛn dilannenw sɔrɔcogo lajɛ, sira jɔcogo, kalan sɔrɔli, fɛnmaracogo wajibiyalenw ani dɛmɛ jamana laɲinilen kɔnɔ.
CONMED
- Mun na a bɛ don lisi surun dɔ la
- Kolotugudaw ni opereli furaw bɛ se ka farikoloɲɛnajɛ furakɛli ni opereli so baarakɛcogo dɛmɛ.
- Typical fit
- Distributeurs minnu ka nafa jiracogo bɛ taabolo baarakɛminɛnw, opereli fɛɛrɛw ani fɛnw doncogo sugandilenw fara ɲɔgɔn kan.
- Fɛn min ka kan ka sɛgɛsɛgɛ
- A ɲɛfɔ ni poroze ɲɛsinnen bɛ fɛnw dontaw ma, minɛnw, kapitali minɛnw walima fɛn minnu bɛ kɛ siɲɛ kelen, o kɔfɛ, aw bɛ baara ni kalanko wajibiyalenw suma ɲɔgɔn na.
OEM ni Distributeur-Supply Model min bɛ se ka sɛgɛsɛgɛ
XC Medico
- Mun na a bɛ don lisi surun dɔ kɔnɔ
- XC Medico bɛ fɛn caman jira joginda, kɔkolo, kolotugudaw, farikoloɲɛnajɛ furakɛli ani minɛnw kɔnɔ, ka fara OEM/ODM ani jagokɛlaw kan.
- Typical fit
- Dugukolo kan jatebɔlaw minnu bɛ fɛn dilannikɛlaw ka kumaɲɔgɔnya tilennen ɲini, ka katalogu bonya, ka minɛnw labɛn minnu bɛ se ka labɛn walima ka yiriwali kɛ mɔgɔ kelen-kelen bɛɛ fɛ.
- Fɛn min ka kan ka sɛgɛsɛgɛ
- Aw ye sariyasɛbɛnw ɲini sisan fɛn dilannenw hakɛ la, minnu bɛ tali kɛ i taayɔrɔ sugu tigitigi la, seereyaw hakɛ, jaw ni fɛnw ɲɛfɔcogo, dantigɛli daliluw, ɲɛmɔgɔya waati kunnafoniw ani poroze kunkanbaaraw sɛbɛnnenw.
Sɛgɛsɛgɛli kɛ kolotugudaw furaw portifaliw, sosiyete ka ɲɛfɔli kunbaba ani kolotugudaw furakɛli OEM/ODM baarakɛlaw.
Sariya min bɛ tali kɛ ɲɔgɔn na: XC Medico man kan ka fɔ ko a bonya, a basigilen sigilen walima a jagokɛcogo bɛ bɛn diɲɛ foroba medtech kulu ma. A nafa min bɛ nin sangaɲɔgɔnma in na, o ye sɔrɔko misali wɛrɛ ye : fɛn dilannikɛlaw ka se sɔrɔli ka bon ani OEM/jagokɛlaw ka jɛkafɔ. Sannikɛlaw ka kan ka o modɛli kiri tigɛ ni dalilu wajibiyalen kelenw ye minnu bɛ kɛ fɛn dilannenw kan, minnu bɛ kɛ ka ɲɛsin feerekɛla bɛɛ ma.
Jagokɛlaw ka kan ka fɛn dilanbaga saba ka lisi surun dɔ jɔ cogo min na
Aw bɛ taa jamanaw, taabolo, fɛn dilannenw denbayaw, sterili cogoya, hakɛ makɔnɔnen, minɛnw, sɛbɛnni magow ani ni mɔgɔ kelen ka taamasiyɛn wajibiyalen don, olu sɛbɛn.
Aw bɛ o ɲinini kelen ci kandidaw ma. Aw bɛ sariya siratigɛ la, yamaruya, QMS hakɛ, dosiye dafalen, misaliw, seko, ɲɛminɛ waati ani sugu kɔfɛ dɛmɛ suma ɲɔgɔn na.
Ka se ka cidenw ka sitɛmu ni minɛnw kulu kelen kɛ. Sɛbɛnw tiɲɛni, misali bɛnkan, kumaɲɔgɔnya, lot fɔlɔ jogo ani fasa baarakɛcogo suman.
Jagokɛla bɛ se ka baara kɛ ni a laɲini ye ka baara kɛ ni feerekɛlaw ye minnu ka ca ni kelen ye. Marka fɛɛrɛbɔlen bɛ se ka dɔgɔtɔrɔso porogaramuw dɛmɛ minnu bɛ tali kɛ mɔgɔw la kosɛbɛ, ka sɔrɔ dɔgɔtɔrɔ kɛrɛnkɛrɛnnen dɔ bɛ dɔgɔtɔrɔso suguya dɔ fa ani OEM dilannikɛla dɔ bɛ dɛmɛ don tenderiw ma minnu bɛ kɛ mɔgɔ kelen-kelen bɛɛ fɛ walima minnu bɛ sɔngɔko jateminɛ. Jagokɛyɔrɔ in ye sariyasunba, fɛnmaracogo, kalanko ani bɛnkan gɛlɛyaba ye.
Ɲininkali minnu ka kan ka kɛ kolotugudaw dilannikɛla bɛɛ la
- Jɔn ye sariya siratigɛ la fɛn dilannikɛla ye? Siti jumɛnw bɛ dilancogo, fɛn dilanni, saniya, pakew dilanni, sterilize, bɔli ani ɲininkaliw ɲɛnabɔcogo kɛ?
- Fɛn tigitigi jumɛnw yamaruyara an ka jamana laɲininen kɔnɔ? Sɛbɛn minnu bɛ se ka ɲini ani sɛbɛnw ɲini minnu bɛ kɔlɔsi, i kana kɛ jɛkulu ka fɔta bɛɛ lajɛlen ye.
- ISO 13485 seere bɛ mun ɲɛfɔ? Jɛkulu, ladɛrɛsi, baarakɛcogo, fɛn dilannenw, bɔli farikolo ani a tiɲɛni bɛ bɛn ɲɔgɔn ma.
- Yala lot kelen banbali bɛ se ka tugu wa? Kɔrɔbɔli jɛɲɔgɔnya ni fɛnw ye, u dilanni, u sɛgɛsɛgɛli, u sɛbɛnni, u foroko, u sterilize yɔrɔ minnu na a bɛ se ka kɛ ani ka u bila.
- Taabolo jumɛnw bɛ kɛ ka ɲɛsin baarakɛlaw ma? Aw ye ɲininkali kɛ cogo min na fɛn dilanbaga kɔrɔlenw ni taabolo kɛrɛnkɛrɛnnenw bɛ se, u kɔlɔsili ani u bɛ fɛn caman sɛgɛsɛgɛ cogo min na.
- Ɲɛtaa waati minnu sɛgɛsɛgɛra, olu ye mun ye? Aw ye kɔsa in na baara kɛcogo, seko ni dɔnko, stock, komandi fitininw, dɛsɛko caya ani a seginni bolodalenw suma ɲɔgɔn na.
- Fɔlifɛnw bɛ dɛmɛ cogo di? Aw ye sanubɔlanw lisɛli lajɛ, u bɛ bɛn ɲɔgɔn ma, u baarakɛcogo kura kunnafoniw, u yɔrɔw caman cili, u dilancogo ani u falencogo.
- Jɔn de ye mɔgɔ tɔgɔ sɛbɛnni ni sugu kɔfɛ baara tigi ye? Sɛbɛnw lasecogo, fɛn caman cili, fɛn caman sɛgɛsɛgɛli, ɲininkaliw, kɔlɔsili ani foro baara kɛtaw bila sɛbɛn kɔnɔ.
Sariyasen daɲɛw koɲɛw: FDA sigicogo sɛbɛnni tɛ FDA ka sɔnni ye, a ka dantigɛli walima a ka yamaruya tɛ. 510(k) ye minɛn kɛrɛnkɛrɛnnenw kunnafoni sira ye ka kɔn sugu ɲɛ, wa a tɛ sosiyete ka seereyaw ye. ISO 13485 ɲɛsinnen bɛ jogoɲumanya ɲɛnabɔli siratigɛ ma ; a tɛ yamaruya di minɛn bɛɛ ma min bɛ katalogu kɔnɔ.
Joliw sɔrɔcogo nafolo minnu bɛ tali kɛ o la
Ɲininkali minnu bɛ kɛ tuma caman na
Jɔnw de ye kolotugudaw dilanbaga ŋanaw ye?
Diɲɛ kolotugudaw ni farikolo-ɲɛnajɛ-tɔnba minnu bɛ kuma sannikɛlaw fɛ tuma caman na, olu dɔw ye DePuy Synthes, Stryker, Zimmer Biomet, Smith+Nephew, Medtronic ani foroba furakɛlitɔnba wɛrɛw ye. Bonya bɛ bɔ mɛtɛrɛ ni jatebɔ waati la, o la, baara kɛ ni sosiyete ka sɛbɛnw ye minnu sɛgɛsɛgɛra ni sɔrɔ jatebɔ wajibiyalen don.
Yala kolotugudaw ka baarakɛyɔrɔba de ye a tilabaga jɛɲɔgɔn ɲuman ye tuma bɛɛ wa?
Ayi, sɛgɛsɛgɛli ni kɛnɛyaso tacogo bɛ se ka kɛ nafa ye, nka jɛɲɔgɔn ɲuman ka kan fana ka waajulikɛyɔrɔ labɛncogo ɲuman di, ka fɛn dilannenw yamaruya, sɛbɛnw, fɛnw marali, minɛnw, kalan, sɔrɔko ani jaabi waati di feerekɛla ka sugu ma.
Ne bɛ se ka kolotuguda dɔ ka FDA cogoya sɛgɛsɛgɛ cogo di?
FDA ka kunnafonidilan ofisiyaliw ɲini ni sariya dilabaga, minɛn tɔgɔ ani dantigɛli sɛbɛnw ye minnu bɛ tali kɛ o ko la. Aw bɛ a dɔn ni fura in saniyalen don, ni a sɔnna, ni a bɔra a la walima ni a bɛ sira wɛrɛ kan. Aw kana sigida tɔgɔ sɛbɛnni walima minɛnw tɔgɔladonni dɔrɔn jate i n’a fɔ dɛmɛ.
Yala ISO 13485 b’a jira ko fɛn bɛɛ dagalen don wa?
No. ISO 13485 seereyaw bɛ jogoɲumanya ɲɛnabɔcogo dɔ ka baarakɛcogo ɲɛfɔ. Sannikɛlaw ka kan ka minɛn tigitigi, a dilabaga sariya siratigɛ la, a dilayɔrɔ, baarakɛcogo laɲininen ani yamaruya min wajibiyalen don u taayɔrɔ sugu la, o sɛgɛsɛgɛ u danma.
Yala ne ka kan ka fɛn dilanbaga dafalen dɔ sugandi walima ka dɔgɔtɔrɔ kɛrɛnkɛrɛnnen dɔ sugandi wa?
Layini dafalen feerela bɛ se ka bɛnkansɛbɛnw ni sistɛmuw sigicogo nɔgɔya. Kɛrɛnkɛrɛnnenya la, dɔgɔtɔrɔ dɔ bɛ se ka kunnafoni caman di fɛɛrɛ kelen na. Aw bɛ kɛnɛyaso dafalenw, minɛnw gɛlɛya, fɛnmarataw, baarakɛcogo, musaka bɛɛ lajɛlen ani baarakɛcogo doni min bɛ sɔrɔ feerekɛla caman ɲɛnabɔli la, aw bɛ olu suma ɲɔgɔn na.
XC Medico ka kan ka suma cogo di ni diɲɛ koloci kuluw ye?
Aw ye sɔrɔyɔrɔ modɛli suma, aw kana jɛkulu ka sɛgɛsɛgɛli suma. XC Medico bɛ se ka kɛ ko nafama ye feerekɛlaw ma minnu bɛ katalogu sɔrɔli caman ɲini, fɛn dilannikɛlaw ka kumaɲɔgɔnya ani OEM/ODM sugandiliw. Aw bɛ sisan fɛn dilannenw hakɛ yamaruya, jogoɲumanya siratigɛ hakɛ, fɛn dilanni daliluw ani fɛnw dilancogo baarakɛcogo sɛmɛntiya sani u ka sɔn.
References réglementaires officielles (Sɔrɔdasi sariyasunw).
- Ameriki FDA: Jogoɲumanya ɲɛnabɔcogo sariya (QMSR) .
- Erɔpu Komisiɔn : EUDAMED ka modulu naani fɔlɔw baara wajibiyalen don
- Ameriki FDA: sɛbɛnni, seereyaw, sɛgɛsɛgɛli ani sɔnni daɲɛw
- Ameriki FDA: 510(k) Kunnafoni minnu bɛ sɔrɔ ka kɔn sugu la, olu kunnafonidilan
