![Kolotugudaw dilanbagaw ani UDI nɔfɛtaama furakɛli minɛnw dilancogo cakɛda dɔ kɔnɔ]()
Kolow furakɛlikɛlaw sugandili tɛ kelen sɔngɔ dɔrɔn ye. Jagokɛlaw fɛ minnu bɛ feere Ameriki dɔgɔtɔrɔsow ni opereli yɔrɔw la, feerekɛlaw ka latigɛ bɛ kɛ farati latigɛ ye : sɛbɛnniw bilali kɔfɛ, o bɛ se ka tenderiw faga, taamasiyɛnw koɲɛw bɛ se ka fɛnw cilenw bali, ani ɲininikɛlaw ka danfara bɛ se ka ɲininkali fitinin dɔ tigɛli kɛ hakilijigin jaabi dafalen ye.
Nin gafe in ye hakilijagabɔ-yɔrɔ ye : a bɛ 'kolo furakɛlikɛlaw' bɛ tali kɛ fɛn min na cogoya la, o ɲɛfɔ, fɛnw dilancogo bɛ baara kɛ cogo min na, Ameriki sariya labatoli jɔnjɔn minnu ka kan ka dɔn, ani sɛgɛsɛgɛli sɛbɛn nafama min bɛ se ka kɛ walasa ka kolotugudaw ni minɛnw feerelaw ka se ka baara kɛ ni minnu ye.
Fɛn minnu bɛ ta ka taa ni u ye, olu kunbabaw
'Jɛkulu furakɛlikɛlaw' bɛ se ka kɛ fɛn dilannikɛla ye, bɛnkansɛbɛn dilannikɛla, walima tilabaga/labɛnbaga—i ka jɔyɔrɔw jɛya sani i ka jateminɛ kɛ.
Ameriki jamana na, aw bɛna a fɛ k’a faamu cogo min na FDA 510(k) ka yamaruya bɛ tali kɛ kolotugudaw caman na ani cogo min na aw bɛ se ka sariya labatoli taamasiɲɛ jɔnjɔnw sɛgɛsɛgɛ.
Fɛn dilanbagaw ka setigiya taabolo barikama ye sɛbɛnni fɔlɔ ye : tuguni, fɛn caman Changement control, sterilisation/packaging validation (ni a bɛnnen don), ani CAPA ka kololi nafa ka bon ka tɛmɛ feereli fɔlenw kan.
UDI traceability tɛ labeling detail dɔrɔn ye—a ye hakilijigin labɛnni ni inventory tiɲɛni kɔkanna ye.
'kolodilabaarakɛlaw' kɔrɔ ye min ye (ani mun na o daɲɛ in bɛ mɔgɔ hakili ɲagami) .
Tiɲɛ na, mɔgɔw bɛ ' kolotugudaw dilanbagaw' kɛ i n’a fɔ sɛbɛn surun ye baarakɛda o baarakɛda la min bɛ se ka kolotugudaw ni minɛnw di tuma bɛɛ—platiw ni juruw, wuluwuluw, kɔkolo sirilanw, kolotugudaw labɛncogo kura, ani minɛnw sigicogo minnu ka kan ka kɛ walasa k’u don.
Nka daɲɛ in bɛ ko kɔrɔba dɔ dogo: 'furakɛla' min bɛ i ka bɛnkansɛbɛn kɔnɔ, o bɛ se ka kɛ:
Sariya siratigɛ la, fɛn dilannikɛla / taamasiyɛn kɛbaga (jɛkulu min ka baara ye ka taamasiyɛnw kɛ, ka sariyaw lase, ani ka wajibiw kɛ sugu kɔfɛ) .
Kontra dilanbaga min bɛ fɛn dilan ka ɲɛsin labelikɛla wɛrɛ ma
Jagokɛla . walima labeler (min bɛ se ka sariyasunba kunkankow Changer)
Sani i ka jatebɔ kɛ feerekɛla dɔ kan, i ka ɲininkali fila ɲɛfɔ:
o ye jɔn ye min ye disiki sɛbɛnbaga ye ? I bɛna min feere Ameriki jamana na,
Baarakɛda jumɛn de ye sariyasunba sɛbɛnw ni fɛn caman Changement-contrôle (Yɛlɛma-kɔlɔsili taabolo) tigi ye?
O jaabiw b’a jira i bɛ se ka min sɛgɛsɛgɛ—ani jɔn de bɛ jaabi di ni fɛn dɔ Changé.
A ka c’a la, kolotugudaw ladonni cakɛda bɛ baara kɛ cogo min na
Lajɛ nɔgɔman bɛ i n’a fɔ nin:
Fɛnɲɛnamafagalanw (misali la, titaniyɔmu sɔgɔlen, kobalt-krom, PEEK ka ɲɛsin fɛn dɔw ma) .
Fɛn dilanni + taabolo kɛrɛnkɛrɛnnenw (masin dilanni, sanfɛla labɛnni, saniya; ka fara sterilize kan fɛn steriliw kama)
Foroko + taamasiyɛn (UDI taamasiyɛn wajibiyalenw sen bɛ o la ni a bɛ se ka kɛ) .
Jogo bɔli + traceability sɛbɛnw (lot/batch controls, DHR ɲɔgɔnna sɛbɛnw, sɛgɛsɛgɛli sɛbɛnw) .
Jagokɛyɔrɔ/donni + tilali (dumuni, fɛnmarayɔrɔ, dɔgɔtɔrɔso lase, fɛnw cili) .
Jagokɛlaw fɛ, a ka c'a la, fɛnw dilancogo dannaya bɛ 'se' walima 'bɔnɛ' yɔrɔ fila la:
Jogoɲumanya siratigɛw : Yala kɔlɔsili ni sɛbɛnw barika ka bon fo u bɛ se ka jatebɔw tɛmɛ ani ka fɛn caman Changements ɲɛnabɔ ni jateminɛ ye wa?
Baarakɛcogo kololi : Yala ɲɛmɔgɔya waatiw, seko ni dɔnko ani kumaɲɔgɔnya bɛ se ka fɔ ka ɲɛ walasa ka fɛnw bali ka ban ani ka tenderi dɛsɛ wa?
Ameriki sariya labatoli jɔnjɔnw nafa ka bon ka faamuya sani aw ka feerekɛlaw tɔgɔ sɛbɛn
Aw man kan ka kɛ sariyasunba koɲɛnabɔla ye walasa ka kolotugudaw dilanbagaw ka se sɔrɔ—nka aw mago bɛ baarakɛcogo faamuyali la, min bɛ se ka sɛgɛsɛgɛ (ani min tɛ se ka sɛgɛsɛgɛ).
1) FDA 510(k): a ye mun ye ani mun na a nafa ka bon
Kolotuguda caman bɛ labɛn i n’a fɔ furakɛli minɛnw Ameriki, wa minɛn suguya caman bɛ don sugu la FDA ka 510(k) sira fɛ (kunnafoni sanni sugu ka kɛ).
FDA bɛ 510(k) cikan suguya caman ɲɛfɔ ani k’a kɔlɔsi ko, minɛn suguya dɔw la minnu faamuyalen don kosɛbɛ, sira min sinsinnen bɛ Lakanali ni baarakɛcogo kan , o bɛ se ka kɛ 510(k) hukumu kɔnɔ—o yɔrɔ la, cidenw bɛ u jigi da baarakɛcogo sariyaw kan minnu dɔnna FDA fɛ sanni ka sɛgɛsɛgɛli tilennen kɛ ni ɲɔgɔn sangali ye ko dɔw la. Ka ye FDA ka Lakanali ni baarakɛcogo basigilen sira 510(k) cikanw kama.
I ka kan ka min kɛ i n’a fɔ jatebɔla: i ka 510(k) nimɔrɔ minnu bɛ bɛn o ma, i k’olu ɲini i ka feerekɛla fɛ, i b’a fɛ ka minnu tila, ani ka sɛbɛn kɔlɔsilen dɔ mara, min b’a jira ko yɔrɔ nimɔrɔ minnu bɛ karti ka taa yɔrɔ minnu na.
2) Ka sigida tɔgɔsɛbɛnni ni minɛnw lisɛli sɛgɛsɛgɛ (nka a kɔrɔ tɛ min na, o faamu) .
FDA bɛ sigida tɔgɔsɛbɛnni ni minɛnw tɔgɔla kunnafoniw di foroba baarakɛminɛnw fɛ, o la FDA ka ɲinini sɛbɛn ni lisi ɲɛ (min bɛ tali kɛ kunnafonidilan ɲininen na).
O nafa ka bon walasa ka a sɛgɛsɛgɛ ko tɔn dɔ bɛ sistɛmu kɔnɔ ani ko baara/minɛn minnu tɔgɔ sɛbɛnna—nka sɛbɛnni/sɛbɛnni dɔrɔn man kan ka jate fɛn dilannenw ka ɲumanya dalilu ye.
3) UDI traceability : a jɔnjɔnw dɔn
FDA ye UDI karamɔgɔya dabɔ walasa ka minɛnw dɔn u tilatilali ni u baaracogo fɛ. Daminɛ ɲuman ye kan gansan ye FDA UDI basigilenw (DI ni PI) ..
Nivo sanfɛla la:
DI (Device Identifier) bɛ minɛn in modɛli/a cogoya jira.
PI (Production Identifier) bɛ se ka lot/batch, serial number, ani production data wɛrɛw sɔrɔ.
Mun na jatebɔlaw ka kan k’u janto : UDI ye hakilijigin waleyali, fɛnmarataw tiɲɛni, ani tugu-tugu-ɲɔgɔn kɔ jigiya kɔkanna nafama ye duguma (dɔgɔtɔrɔsobaw ni kulu sanni siraw bɛ ka caya ka taa a fɛ ka kunnafonidilanw bɔli makɔnɔ UDI teriw fɛ).
Seko ni dɔnko sɛgɛsɛgɛli sɛbɛn min bɛ se ka kɛ kolotugudaw furakɛlikɛlaw ye
Nin ye dakun ye ekipu fanba b’a fɛ ka min sɔrɔ ka kɔn tender fɔlɔ waati dantigɛlen ɲɛ.
A. Sɛbɛn minnu ka kan ka ɲini ka kɔn fɛn wɛrɛw ɲɛ
Aw ye aw jija ka 'supplier due diligence packet' dɔ lajɛ, aw bɛ se ka baara kɛ ni min ye kokura tenderw bɛɛ kɔnɔ:
Jogoɲumanya seereyaw (misali la, ISO 13485 hakɛ, a bɔli jɛkulu, a baara donw) .
Sariyasunba cogoya sɛbɛnw minnu bɛ tali kɛ i ka sugu doncogo fɛɛrɛ la (misali la, minɛnw bɔli yɔrɔ minnu na a bɛ se ka kɛ) .
Traceability overview (lot/batch controls, labeling, UDI bɛ ɲɛnabɔ cogo min na)
Stérilisation validation surme (ka ɲɛsin sterilizew/minɛnw ma) .
Foroko tiɲɛni kuncɛlen (bariyɛri sterili dafalen ni tilali sɛgɛsɛgɛli) .
Yɛlɛma donna kɔrɔsili sariya la (u bɛ kiliyanw ladɔnniya cogo min na, mun bɛ segin-ka-bɔnye bila sen kan)
Jalakiw ɲɛnabɔcogo + CAPA lajɛba (koɲɛw bɛ sɛgɛsɛgɛ cogo min na ani u bɛ bali cogo min na) .
Key Takeaway : Ni feerekɛla tɛ se ka sɛbɛnw pake saniyalen di, min bɛ se ka jateminɛ, i bɛna o sara kɔfɛ—ni tenderiw bɛ mɛn, ni fɛnw cili bɛ to sen na, walima ni dimi bɛ kɛ ka segin-ka-bɔ jateminɛw senfɛ.
B. Sɛgɛsɛgɛli sinsin yɔrɔw (minnu ka kan ka ɲini yɔrɔ la walima yɔrɔjan jatebɔ jugu la) .
Ni aw bɛ jateminɛ kɛ (walima ni aw ye jateminɛ kɛ), aw bɛ aw sinsin kɔrɔsilifɛnw kan minnu bɛ bɛnkan fɔ:
Traceability drills : 'I b'a jira n na i bɛ nin SKU in trace cogo min na k'a ta fɛnɲɛnamafagalan fɔlɔ la ka se a cilen ma.'
Taabolo tiɲɛni kololi : taabolo kɛrɛnkɛrɛnnenw i n’a fɔ sterilize ni pakew dilanni ka kan ka kɛ ni tiɲɛni dalilu jɛlenw ye.
Baarakɛbaliya ni CAPA : yala u bɛ se ka miirili jujɔn ni banakunbɛn wale jira min bɛ nɔrɔ wa ?
Kalan ni seko : jɔn de yamaruyara ka fɛn dilannen bɔ kɛnɛ kan, ka sɔn deviations ma, ani ka fɛn caman ɲɛnabɔ fɛn caman Changements ?
Fournisseurs contrôles : u bɛ se ka u yɛrɛ ka sub-supplier kɔrɔlenw kɔlɔsi cogo di ani k’u kɔlɔsi ?
C. Baarakɛcogo sariyaw minnu bɛ nɔ bila diɲɛ kɔnɔ fɛnw sɔrɔli dannaya la
Jagokɛlaw fɛ, 'jogo' tɛ ɛntɛrinɛti dɔrɔn ye—a bɛ kɛ fana ni feerekɛla bɛ se k’i to fɛnmarayɔrɔ la.
Aw ye layidu talenw ɲini minnu bɛ se ka suman ani ka jɛya sɔrɔ ninnu kan:
Lead-time ɲɛfɔliw (SKU standard ni non standard) .
Seko ni dɔnko gɛlɛyaw (mun bɛ kɛ ɲininiw caya waati la?) .
Kɔrɔfɔli ni tilali sariyaw
Consignation / VMI sugandiliw (ni u dira) .
Kumaɲɔgɔnya cadence: i bɛna kunnafoni sɔrɔ cogo min na waati latɛmɛni walima fɛn caman Changements
Darapo bilenman minnu bɛ hakilijigin nataw, kɔtigɛlenw, walima tender dɛsɛw fɔ
Baara kɛ ni ninnu ye i n'a fɔ 'dabila ka sɛgɛsɛgɛli' lisi waleyali:
Sɛbɛn minnu tɛ ni dakun jɛlen ye (u bɛ jago baara ɲɛfɔ nka a tɛ kɛ fɛn dilanni taabolo kan) .
'Fɛn bɛɛ b'an bolo' fɔlenw ni minɛn ni minɛn daliluw tɛ (clearances, traceability records)
Yɛlɛma kunnafonidi taabolo sɛbɛnnen tɛ (walima fɛn caman b’a jira ko fɛn caman b’a jira ko fɛn caman b’a jira ko fɛn caman b’a jira ko fɛn caman b’a jira ko fɛn caman b’a la ka fɛn caman sɛmɛntiya) .
Fura sterili fɔlenw ni tiɲɛni kuncɛlen tɛ aw bɛ se ka segin u kan
Dafabaliya min bɛ to senna, ko jɔn ye sɛbɛn dilabaga/dilanbaga ye
Tile 30 kɔnɔna na, sɛgɛsɛgɛli kɛcogo nɔgɔman dɔ
N’i b’a daminɛ zeru la, nin ye ɲɔgɔndan ye min bɛ kɛ tiɲɛ na, min bɛ baara to a cogo la.
Tile 1–7 : Jɛkulu jɔyɔrɔ jɛlen + sɛbɛnni pake
Aw ye a sɛgɛsɛgɛ jɔn ye sɛbɛnnikɛlan/sɛbɛn dilabaga ye minɛn denbaya kelen-kelen bɛɛ la.
Aw bɛ due diligence pake ɲini (seereyaw, traceability overview, validation summaries).
SKU laɲinitaw karti ka taa u ka sariyasunba jiralanw na (ni a bɛ se ka kɛ yɔrɔ minnu na).
Tile 8–21: Sɛgɛsɛgɛli + jatebɔ labɛnni
Foroba taamasiyɛnw sɛgɛsɛgɛ (sɛbɛnni/sɛbɛnni yɔrɔ minnu na a bɛnnen don; minɛnw dantigɛliw dafa).
Aw ye aw ka jatebɔ sɛbɛn jɔ aw ka tender ni dɔgɔtɔrɔso wajibiyalenw lamini na.
A latigɛ ni i bɛna jatebɔ kɛ k’a ɲɛsin i yɛrɛ ma walima ni i bɛna baara kɛ ni mɔgɔ sabanan ye min bɛ se kosɛbɛ.
Tile 22–30: Piloti yamaruya + baarakɛcogo lajɛ
A daminɛ ni piloti ka yamaruya ye min bɛ kɔrɔsi.
Track delivery dannaya, sɛbɛnw dafalen, pakew cogoya, ani jaabi.
I ye min kalan, i k’o sɛbɛn—o kɔfɛ, i k’a latigɛ ni i bɛna sɛgɛsɛgɛli kɛ.
Wideyo: UDI basigilenw miniti 3 jukɔrɔ
Ɲɛfɔli surun dɔ bɛ duguma min bɛ se ka dɛmɛ don ka feereli, ops, ani QA jɛkuluw bɛn ɲɔgɔn ma mun na UDI nafa ka bon tugu-tugu-ɲɔgɔn kɔ la.
Wideyo: 'FDA ka minɛn kɛrɛnkɛrɛnnenw dɔnbaga (UDI) ka wajibiw' (Registrar Corp)
Fɛn nataw minnu bɛ kɛ
N’aw b’a fɛ ka daminɛyɔrɔ sɔrɔ feerekɛlaw ka jateminɛ kama, aw bɛ sanfɛla lajɛ sɛbɛn tigɛli kɛ ka kɛ ɲɛ kelen jatebɔ sɛbɛn ye, ka baara kɛ n’a ye tuma bɛɛ kandida kelen-kelen bɛɛ kɔnɔ.
Ni aw mago bɛ misali lakika fana na, min b’a jira cogo min na fɛn dilannikɛla bɛ portfolio scope ni fulfilment claims jira, aw bɛ se ka foroba kunnafoniw lajɛ kan XC Medico (misali la, fɛn dilannenw suguya minnu tɔgɔ sɛbɛnna, fɛnmarataw ani cikanw), sosiyete ka jateminɛ kɛlenw kan XC Medico About Us page , ani—ni OEM/ODM ye i ka modɛli dɔ ye—a... Gafe laban min bɛ ɲɛsin kolotugudaw OEM & ODM sanni ma . Aw ye feerekɛlaw ka sitiw jate i n’a fɔ daminɛyɔrɔ—o kɔfɛ, aw bɛ sɛbɛnw ni tugucogo sɛgɛsɛgɛ aw yɛrɛ ka seko ni dɔnko siratigɛ la.
Kɔrɔfɔli: Nin barokun ye kunnafoni dɔrɔn de kama, wa a tɛ kɛ sariyaw walima sariya ladilikan ye. Wajibiya bɛ danfara ka kɛɲɛ ni minɛn suguya ni kiritigɛyɔrɔ ye.
