Aw bɛ baara kɛ ni nin sɛgɛsɛgɛli tan ninnu ye walasa ka kolotugudaw dilannikɛlaw suma ɲɔgɔn na sariyaw hakɛ, u nɔfɛtaama, u jogoɲini, u dilanni labɛnni, jago sariyaw ani dɛmɛ kuntaalajan na — aw kana kɛ sɔngɔ fɔli dɔrɔn kan.
Jaabi teliya la
Kolotugudaw dilannikɛla min bɛ se ka da a kan, o ka kan ka se ka daliluw di — a man kan ka layidu dɔrɔn ta — minnu bɛ tali kɛ a ka sariya siratigɛ la, a jogoɲumanya ɲɛnabɔli hakɛ, a ka sugu yamaruya min bɛ sɔrɔ fɛn kɛrɛnkɛrɛnnenw na, a ka fɛn dilannenw nɔfɛtaama, a dilanni ni a kɛcogo tiɲɛni, a dilanni seko, OEM sariyaw, a lasecogo kɔlɔsili, a ka ɲininkaliw ɲɛnabɔcogo ani a ɲɛfɔli minnu bɛ tali kɛ i ka sugu la.
Aw bɛ a daminɛ ni sɛbɛnw ye, k’u sɛgɛsɛgɛ aw yɛrɛ ye, ka izini b’a ka fɛɛrɛw tigɛ cogo min na, aw bɛ o sɛgɛsɛgɛ, ani ka misali yamaruyasɛbɛn dɔ dafa min bɛ kɔrɔsi sani aw ka layidu ta waatijan kɔnɔ.
Ka kolotugudaw dilabaga sugandi, o ye faratiw kunbɛnni desizɔn ye. Ni quotation dɔgɔman bɛ se ka kɛ sɔngɔba ye ni seereyaw hakɛ tɛ bɛn fɛn dilannen ma, ni minɛnw ma dafa, ni sɛbɛnw bɛ sɛbɛnni bila kɔfɛ, walima ni u falenni tɛ se ka da a kan. O waati kelen na, site web polisilen walima fɛn dilannenw gafe janyalen t’a jira ko fɛn dilannikɛla bɛ se ka i ka sugu laɲinitaw ka ɲininiw dafa.
Nin gafe in dabɔra diɲɛ kɔnɔ kolotugudaw tilabaga, fɛnw donbagaw, dɔgɔtɔrɔso sannijɛkuluw ani sannikɛlaw ye minnu bɛ kɛ ni tɔgɔlatɔn kelen ye. A bɛ sinsin ɲininkaliw ni daliluw kan minnu ka kan ka kɛ sani feerekɛlaw ka sɔn. A tɛ sariyaw lajɛ, jogoɲini, sariya lajɛ walima kɛnɛyaso jateminɛ nɔ bila.
Sɛbɛn minnu ka kan ka ɲini sani i ka quotations suma ɲɔgɔn na
Aw bɛ a ɲini fɛn dilannikɛla bɛɛ fɛ minnu tɔgɔ sɛbɛnna, aw ka dalilu kelen in sɔrɔ. Delili sariyalen bɛ danfara nɔgɔya ani ka dɔ bɔ farati la ka sosiyete dɔ sugandi bawo a ye jagofɛnw di minnu bɛ mɔgɔ ɲɛnajɛ — nka u dafalen tɛ.
| Seginkanni yɔrɔ | Dalilu minnu ka kan ka ɲini Fɛn | minnu ka kan ka sɛgɛsɛgɛ | Lasɔmini taamasiɲɛ min bɛ kɛ tuma bɛɛ |
|---|---|---|---|
| Sosiyete ka danyɔrɔ | Jagokɛla ka lase, izini ladɛrɛsi ani sariya siratigɛ la fɛn dilannikɛlaw ka kunnafoniw | Baarakɛɲɔgɔn, fɛn dilannikɛla ani seeretigi bɛ ɲɔgɔn na ka jɛya | Jagokɛla dɔ bɛ jira iko sariya siratigɛ la fɛn dilannikɛla k’a sɔrɔ ɲɛfɔli ma kɛ |
| Jogoɲumanya siratigɛ la | Sisan ISO 13485 seere ni a bonya | Jagokɛla, tiɲɛni, ladɛrɛsi, baarakɛcogo ani fɛn dilannen suguya minnu bɛ datugu | Seere in waati tɛmɛna walima a hakɛ tɛ fɛn ɲininenw dafa |
| Suguda sɔrɔli | Fɛn kɛrɛnkɛrɛnnenw tɔgɔsɛbɛnniw, u ka laseliw, u ka seereyaw walima u ka fɔtaw | Modeli tɔgɔw, sugu laɲininen, seere nimɔrɔ ani sisan cogoya | Sosiyete tɔgɔsɛbɛnni ɲɛfɔlen don iko sɔnni min bɛ kɛ fɛn bɛɛ la |
| Traceability (Sɔrɔcogo). | Sample material certificat, lot sɛbɛn, taamakɛla ani sɛgɛsɛgɛli sɛbɛn | Sɛbɛnw bɛ fɛnɲɛnamafagalanw, fɛn dilanni yɔrɔ ani fɛn dilannenw cɛsiri | Fɛnɲɛnɛmako ɲɛfɔli jɛlen dɔrɔn de bɛ sɔrɔ |
| Validation (daɲɛw tiɲɛni). | Dalilu minnu bɛ tali kɛ dilancogo, masinw, baarakɛcogo, saniya ani pakew dilanni na | Dalilu bɛ tali kɛ modɛli ni a labɛncogo ɲininen na | Kɔrɔbɔli kuncɛlenw bɛ misali nimɔrɔw, fɛɛrɛw walima sɔnni sariyaw bɔ yen |
| Supply baarakɛcogo | Seko ni dɔnko fɔcogo, ɲɛminɛ waatiw sariyalenw ani kɔsa in na fɛnw dicogo kunnafoniw | Waati min fɔra, o bɛ seko lakika ni fɛnmarataw sɔrɔli jira | Koman bɛɛ ɲɛfɔlen don ko kɔrɔtɔko bɛ se ka kɛ ni kunnafoniw dɛmɛni tɛ |
| Feere kɔfɛ kɔlɔsili | Jalaki, CAPA, kɔlɔsili ni hakilijigin taabolo | Kunkanbaaraw ni jiginni waatiw ɲɛfɔlen don | Taabolo sɛbɛnnen si tɛ yen cilen kɔfɛ |
1Aw ye sosiyete ka sariya siratigɛ la ani a ka fɛn dilanni jɔyɔrɔ dafa
Fɔlɔ k’a dɔn jɔn de bɛna o fɛnw donna, jɔn de ye o dilancogo n’a tɔgɔ sɛbɛn, jɔn bɛna bɔ sɛbɛnfura kan, ani jɔn bɛna a bolonɔ bila bɛnkansɛbɛn na. 'Furnisseur,' 'factory,' 'brand owner' ani 'sariya dilanbaga' tɛ otomatiki ye fɛn kelen ye.
Aw bɛ sosiyete tɔgɔ ni ladɛrɛsi minnu jiralen bɛ jagosɛbɛn kan, jogoɲumanyasɛbɛn kan, fɛn dilannenw sɛbɛnw, quotation, label artwork ani banki jatebɔsɛbɛn kan, olu suma ɲɔgɔn na. Ni tɔn wɛrɛw sen bɛ o ko la, aw bɛ ɲɛfɔli sɛbɛn ɲini u jɔyɔrɔw n’u ka jɛɲɔgɔnya kan bɛnkansɛbɛn kɔnɔ.
- Aw ye fɛn dilanni ladɛrɛsi farikoloma sɛgɛsɛgɛ, aw kana feerekɛyɔrɔ ladɛrɛsi dɔrɔn sɛgɛsɛgɛ.
- Aw ye ɲininkali kɛ ko taabolo minnu bɛ kɛ so kɔnɔ ani minnu bɛ kɛ baarakɛlaw fɛ.
- Aw ye a sɛgɛsɛgɛ jɔn bɛ dilancogo caman yeli, fɛɛrɛko dosiyew ani ɲininkaliw sɛgɛsɛgɛliw kɔlɔsi.
- Ni mɔgɔ kelen-kelen ka porozɛw bɛ kɛ, aw k’a dɔn mɔgɔ jumɛn bɛna tɔgɔsɛbɛnw kɛ sugu kelen-kelen bɛɛ la.
2Aw bɛ jogoɲumanya-sigida hakɛ sɛgɛsɛgɛ ani suguya kɛrɛnkɛrɛnnenw ka sugu yamaruya
ISO 13485 ye furakɛli-minɛnw jogoɲini sariya ye, nka seere ka kan ka lajɛ a kɔnɔkow la. Sariyasenw lajɛ, yɔrɔ ladɛrɛsi, baara minnu bɛ datugu, fɛn dilannenw suguyaw, u bɔli ni u dafa donw, ani seereyaw jɛkulu cogoya lajɛ. Sɛbɛn min bɛ se ka kɛ, o ye daminɛ nafama ye; a tɛ fɛn kɛrɛnkɛrɛnnen daliluw nɔnabila ye.
Ameriki ta fan fɛ, i kana sɔn 'FDA sɛbɛnnen' walima 'FDA ka seereyaw' ma, k'o kɛ dalilu ye min b'a jira ko minɛn dɔ saniyalen don walima ko a sɔnna. FDA b’a fɔ ko sigida tɔgɔsɛbɛnni ni minɛnw tɔgɔladonni tɛ sɔnni, yamaruya walima yamaruya jira. Aw bɛ furaw danfaracogo ni u cicogo kunnafoniw ɲini minnu bɛ tali kɛ u la, ni a mago bɛ o la, ani ka u sɛgɛsɛgɛ FDA ka kunnafonidilan kɔnɔ min bɛ tali kɛ o la.
Erɔpu tɔnba ta fan fɛ, aw ye a dilabaga jɔyɔrɔ lajɛ sariyasen (UE) 2017/745 kɔnɔ, bɛnkan-sɛgɛsɛgɛli sira min bɛ sirataama, bɛnkansɛbɛn jirali ani seereyaw hakɛ. Ni a bɛnnen don, aw bɛ kunnafoni-di-jɛkulu ni seereyaw kunnafoniw sɛgɛsɛgɛ Erɔpu jamanaw ka nafolo ofisiyali fɛ i n’a fɔ EUDAMED.
Aw kana sɔn feerekɛla dɔ ma min sinsinnen bɛ logow kan
ISO, CE ani FDA taamasiyɛn minnu bɛ gafenin dɔ kɔnɔ, olu tɛ dalilu bɛrɛ ye. Sɛbɛn walima cikan nimɔrɔ tigitigi sɛbɛn, sariya jɛkulu min bɛ datugu, fɛn dilannenw denbaya, modɛli ani sugu laɲinitaw, o kɔfɛ, aw bɛ fɛn kelen-kelen bɛɛ sɛgɛsɛgɛ u yɛrɛma.
XC Medico ye seereyaw sɛbɛnw misaliw di
Ja minnu bɛ duguma, olu ye sɛbɛnw misaliw ye walasa ka seginnkanni fɔlɔ kɛ. Sani feerekɛlaw ka sɔnni kɛ, aw bɛ sisan kopi dafalenw ɲini ani ka sariyasɛbɛn, fɛn dilanyɔrɔ, seere nimɔrɔ, seere dibaga, baara kɛdonw, baara minnu bɛ datugu ani fɛn dilannenw hakɛ sɛgɛsɛgɛ.
TÜV SÜD CE ka seereyaw sɛbɛn misali
TÜV SÜD ISO 13485 seereyaw sɛbɛn misali
Spine FSC sɛbɛn misali
ISO 13485 seereyaw sɛbɛn misali
Sɛbɛn jaw bɛ jira walasa ka ɲɛfɔli kɛ dɔrɔn, wa u man kan ka jate dalilu ye min b’a jira ko fɛn bɛɛ yamaruyara sugu bɛɛ la.
3Aw ye fɛnɲɛnamafagalanw ni u dilanni nɔfɛtaama lajɛ
Kolotugudaw sɔrɔli tɛ fɛn caman wajibiya ka tɛmɛ fɛn dɔ hakɛ dɔ dantigɛli kan gafesɛbɛn dɔ kan. Aw bɛ a ɲini a dilabaga fɛ a k’a jira cogo min na fɛn donta dafalen bɛ se ka sɔrɔ ka segin kɔfɛ ni masinw ye, ni funteni furakɛli ye walima ni a sanfɛla furakɛli ye, ni sɛgɛsɛgɛli ye ani fɛnɲɛnamafagalanw sɛbɛnni minnu bɛ na.
Traceability sample nafama ka kan ka fɛn dilannenw lot walima serial identifier ni raw-material seere, production traveller, key process records ani sɛgɛsɛgɛli laban siri ɲɔgɔn na. Kɔrɔbɔli tigitigiw ni sariyakolow bɛ bɔ minɛn, fɛn dilannen, baarakɛcogo laɲininen ani suguya de la; aw kana aw yɛrɛ tanga sɛgɛsɛgɛli sɛbɛn jɛlen dɔ ma min bɛ kɛ ka ɲɛsin fɛnw doncogo denbaya bɛɛ ma.
- Aw bɛ misali batch sɛbɛn sɛgɛsɛgɛlen ɲini walasa ka fɛn dɔ sɔrɔ min bɛ se ka suma ɲɔgɔn ma.
- Aw ye a lajɛ cogo min na fɛn minnu tɛ bɛn ɲɔgɔn ma, olu bɛ dɔn, u bɛ faranfasi cogo min na ani u bɛ bila cogo min na.
- Aw ye ɲininkali kɛ cogo min na taabolo kɛrɛnkɛrɛnnen minnu bɛ kɛ kɛnɛma, olu bɛ to ka tugu ɲɔgɔn kɔ.
- Aw ye a sɛgɛsɛgɛ ko jogoɲumanya sɛbɛnw bɛ mara waati hakɛ min na sugu min ɲɛsinnen bɛ o ma.
XC Medico ka forobaciyɛn orthopedic implant quality-control overview bɛ se ka kɛ baro daminɛ ye, nka sannikɛla ka kan ka dalilu ɲini hali bi fɛn dilannenw ni lot kɛrɛnkɛrɛnnenw kan setigiya waati.
4Sɛgɛsɛgɛli kɛ dilancogo tiɲɛni na, taabolo tiɲɛni ani kɔrɔbɔli
Aw ye ɲininkali kɛ dalilu jumɛnw b’a jira ko aw b’a fɛ ka fɛn minnu donna fɛnw doncogo tigitigi la. Kɔrɔbɔli rapɔɔri min bɛ kɛ ka ɲɛsin hakɛ, fɛn walima cogoya wɛrɛ ma, o bɛ se ka kɛ ko a tɛ mɔgɔ jira. A dilabaga ka kan ka se k’a ɲɛfɔ cogo min na cogoya sɛgɛsɛgɛlen sugandira ani a sɔrɔlenw bɛ tali kɛ cogo min na fɛn dilannenw denbaya bɛɛ kɔnɔ.
Ka kɛɲɛ ni fɛn dilannen ye, seginnkanni bɛ se ka kɛ dilancogo dontaw ye, faratiw kunbɛnni, hakɛ sɛgɛsɛgɛli, masinw sɛgɛsɛgɛli, biyocompatibility, saniya, pakew dilanni, sterilize walima baarakɛcogo kɛrɛnkɛrɛnnenw tiɲɛni. Aw ka jogoɲumanya ni sariyasunba jɛkuluw ka kan k’a ɲɛfɔ sɛbɛn minnu ka kan ka kɛ sugu laɲininen na ani baarakɛcogo laɲininen na.
Izini seginnkanni senfɛ, aw bɛ sɛbɛnni kɛcogo suma ni fɛn dilanni yɛrɛ ye. XC Medico bɛ foroba kunnafoni di a ka... kolotugudaw dilanni taabolo ; jatebɔlaw ka kan ka baara kɛ ni o kunnafoniw ye walasa ka jatebɔ ɲininkali kɛrɛnkɛrɛnnenw labɛn sanni u ka siti ɲɛfɔli dɔ jate jatebɔ dalilu ye.
5Aw bɛ fɛn dilannenw jatebɔsɛbɛn, minɛnw ani sistɛmu dafalen jateminɛ
Katalogu belebeleba nafa ka bon dɔrɔn ni i ka kiliyanw mago bɛ sistɛmu minnu na, olu dafalen don, ni u sɛbɛnnen don tuma bɛɛ ani ni u bɛ sɔrɔ tiɲɛ na. Aw bɛ fɛnw dontaw, minɛnw, sanubɔlanw, kɛsu, fɛnw, u bonya hakɛw ani u falenfɛnw lajɛ i n’a fɔ sigida kelen.
- SKU minnu ye sariya ye, minnu dilannen don ka kɛɲɛ ni komandi ye walima minnu bɛ bɔ dɔɔnin dɔɔnin, aw ye a sɛgɛsɛgɛ.
- Aw bɛ a lajɛ ni minɛnw ni fɛnw doncogo suguyaw bɛ bɛn sɛbɛncogo kelen ma.
- Aw ye sɛbɛnniw lajɛ, baarakɛcogo cikanw ani pakew labɛncogo suguya fɛ.
- Aw ye ɲininkali kɛ cogo min na dilancogo caman yeli ani yɔrɔ minnu dabilalen don, olu bɛ lase ɲɔgɔn ma.
- Aw ye a jira ko bɛnkan fɔlenw sɛbɛnnen don ani ko u dan ye farankanw ye minnu sɛgɛsɛgɛra.
Aw kana sɔn kumasenw ma minnu ka bon i n'a fɔ 'a bɛ bɛn sistɛmu bɛɛ ma' walima 'MRI lakananen' ni minɛn kɛrɛnkɛrɛnnenw taamasiyɛnw tɛ ani dalilu minnu bɛ a dɛmɛ. Bɛnkan ni MR lakanani kunnafoniw ka kan ka jateminɛ ka ɲɛsin fura tigitigi ma ani cogoya laɲinitaw ma.
6Aw bɛ fɛn dilanni seko, fɛnw maracogo ani fɛnw lasecogo kɔlɔsili lajɛ
Seko ka kan ka jateminɛ ka kɛɲɛ ni i ka jateminɛ ye, a man kan ka jateminɛ i n’a fɔ izini nimɔrɔ min bɛ a yɛrɛ ma. SKU ɲagaminen lakika, komandi kɛcogo, tenderi waatibolodacogo ani laɲini baarakɛcogo hakɛ tila ɲɔgɔn na. O kɔfɛ, aw bɛ a ɲini dilanbaga fɛ a ka seko sɔrɔlenw ɲɛfɔ, buteliw dacogo, fɛnmaracogo sariya ani ɲɛmɔgɔya waati jateminɛw.
Aw ye danfara min bɛ fɛnw ni ɲɔgɔn cɛ minnu bɛ sɔrɔ, u dilanni sariyalen ani fɛnw minnu bɛ kɛ ka kɛɲɛ ni mɔgɔw sago ye, olu lajɛ. Aw ye ɲininkali kɛ cogo min na fɛnɲɛnamafagalanw dɛsɛ, baarakɛlaw ka baarakɛcogo, minɛnw ladonni ani ɲininiw hakɛ cayalenba bɛ ɲɛnabɔ cogo min na. Kɔsa in na, kunnafoniw dicogo waati la, komandi minnu bɛ se ka suma ɲɔgɔn ma, olu nafa ka bon ka tɛmɛ layidu caman kan, n’o ye ka ci teliya la.
XC Medico ka baarakɛyɔrɔ implant supply-chain and warehousing overview b’a ka foroba taabolo jɔyɔrɔ ɲɛfɔ. Jagokɛla ka kan ka tugu ni sisan sɔrɔcogo ja ye ani waati sɛbɛnnenw ye, minnu bɛ kɛ sistɛmu tigitigiw kama minnu bɛ jateminɛ na.
7OEM/ODM, MOQ ani hakili-la-ko-kumasenw ɲɛfɔ
Porozɛ minnu bɛ kɛ ni mɔgɔ kelen-kelen bɛɛ ye ani minnu bɛ kɛ ka kɛɲɛ ni mɔgɔw sago ye, olu bɛ latigɛw de wajibiya minnu tɛ dafa ni sɔngɔ kelen ye. Sani aw ka sɔn misaliw ma, aw bɛ sɛbɛn kɛ jɔn ye ja, baarakɛminɛnw, sɛgɛsɛgɛli kunnafoniw, pakew dilanni seko ni dɔnko baara ani mɔgɔ tɔgɔ sɛbɛnni minnu bɛ sɔrɔ o la. Kunnafoni gundow bɛ lakana cogo min na, ani ni dilanw bɛ se ka di kiliyan wɛrɛw ma, olu ɲɛfɔ.
- A’ ye standard private labeling faranfasi ka bɔ design customization lakika la.
- Aw bɛ misali, tiɲɛni ani sɛnɛ-sɔn-ni-sɔn taabolo ɲɛfɔ.
- Aw bɛ komandi hakɛ fitininw sɛbɛn SKU fɛ ani sistɛmu dafalen fɛ.
- Aw bɛ bɛn dilancogo caman caman cili kunnafoni ni a tiɲɛni kunkankow kan.
- Baarakɛminɛnw tigiyali, waajulikɛyɔrɔ sariyaw ani baara dabila hakɛw ɲɛfɔ.
Walasa ka jago seginnkanni jugumanba sɔrɔ, baara kɛ ni nin ye OEM dilannikɛla ka sɛgɛsɛgɛli sɛbɛn min bɛ i ka jogoɲumanya ni sariyako jateminɛ kɛrɛfɛ.
8Aw ye sɛbɛnni, tender ani fɛɛrɛ-sɛbɛnw dɛmɛni jateminɛ
Dilanbaga dɔ bɛ se ka fɛnw dilan minnu bɛ sɔn, wa hali bi a tɛ se ka kɛ kosɛbɛ ni a ka sɛbɛnw tɛ dɛmɛ don ka i tɔgɔ sɛbɛn walima ka tender kɛ i ka sugu la. Sɛbɛnw matirili dɔ dabɔ sani i ka jago komandi fɔlɔ kɛ.
Matirisi ka kan ka sɛbɛn wajibiyalen kelen-kelen bɛɛ jira, a tigi, kan, a cogoya, a lajɛcogo, a dili don makɔnɔnen ani a gundo cogoya. Aw ye a lajɛ cogo min na a dilabaga bɛ fɛn kuraw kɔlɔsi ni seere, taamasiyɛn, cikan, fɛn ɲɛfɔcogo walima a dilanni fɛn caman Changé.
Aw bɛ sɛbɛnw pake dɔ ɲini min bɛ kɛ sugu kɛrɛnkɛrɛnnen na
Sani i ka ɲininkali kɛ ko 'Yala CE walima FDA bɛ i la wa?', i ka jamana laɲinitaw, furaw denbaya ani misali lisɛli di. A ɲini dilanbaga fɛ a ka SKU kelen-kelen bɛɛ karti ka kɛɲɛ ni sariyaw ni fɛɛrɛ daliluw ye minnu bɛ sɔrɔ. Aw ye sariyasunba baarakɛlaw bila ka a sɛgɛsɛgɛ ko sɛbɛnw bɛ se ka kɛ aw ka sugu laɲininen na.
9Aw ye ɲininkaliw ɲɛnabɔcogo lajɛ, CAPA ani hakilijigin labɛnni
Fɛn minnu bɛ kɛ cidenw cilen kɔfɛ, olu ka setigiya ka kan ka ɲɛfɔ. Aw ye ɲininkali kɛ ɲininkaliw bɛ sɔrɔ cogo min na, u bɛ jateminɛ cogo min na, u bɛ sɛgɛsɛgɛ cogo min na, u bɛ taa ɲɛ cogo min na ani u bɛ datugu cogo min na. A’ y’a jira cogo min na fɛn dilannikɛla bɛ ko minnu bɛ se ka fɔ, foro walew, hakilijiginw ani latilenni walew lase jatebɔlaw ni sɔrɔko baarakɛla wɛrɛw ma.
- Jɔn de ye ɲininkali ni kɔlɔsili jɛɲɔgɔnya fɔlɔ ye?
- Kunnafoni jumɛnw de ka kan ka kɛ walasa ka sɛgɛsɛgɛli daminɛ?
- Fɛn minnu bɛ segin ka na, olu bɛ kɔlɔsi ani ka sɛgɛsɛgɛ cogo di?
- A jujɔ, CAPA ani nafa sɛgɛsɛgɛliw bɛ sɛbɛn cogo di?
- Lotiw ni kiliyan minnu tɔɔrɔla, olu bɛ dɔn cogo di foro baara dɔ senfɛ?
Aw kana aw jigi da 'fɛɛrɛ dɛmɛni' kan min tɛ labɛn ye, k'a kɛ sugu kɔfɛ taabolo sɛbɛnnenw nɔnabila ye ani sariyasunba kunkanbaaraw minnu tilalen don ka jɛya.
10Aw bɛ misali komandi ni feerekɛlaw ka jatebɔsɛbɛn ɲɛminɛlen dɔ boli
Misali la, komandi min bɛ kɛ, o bɛ fɛn caman kɔrɔbɔ ka tɛmɛ fɛn dilannenw cogoya kan. Baara kɛ n’a ye walasa ka quotation tiɲɛni jateminɛ, sɛbɛnw kɔlɔsili, sɛbɛnni, pakew, kumaɲɔgɔnya, ɲɛminɛ waati, sɛgɛsɛgɛli jaabiw ani ɲininkaliw jaabi. Sɔncogo sariyaw sɛbɛn sani misali ka komandi.
Aw bɛ fɛn dilannikɛla kelen-kelen bɛɛ jate ni sariya girinman kelenw ye. Jatebɔsɛbɛn danmadɔ bɛ se ka kɛ sariyaw bɛnkan ye, jogoɲumanya daliluw, tugu-tugu-ɲɔgɔn kɔ, fɛɛrɛko seko, sistɛmu dafalen, sɔrɔko dannaya, sɛbɛnw, jago sariyaw ani dɛmɛ. Aw bɛ sɔngɔ jate fɛn kelen ye sanni ka kɛ fɛn ye min ka bon kosɛbɛ.
| Category | Sugged weight | Misali la, jatebɔ ɲininkali |
|---|---|---|
| Regulateur ani qualité-systeme bɛ bɛn | 25% ye . | Yala dalilu sɛgɛsɛgɛlenw bɛ sariya siratigɛ la, yɔrɔ, fɛn dilannen ani sugu laɲinitaw ɲɛfɔ wa? |
| Traceability ani validation (Sɔrɔli ni tiɲɛni). | 20% ye . | Yala feerekɛla bɛ se ka fɛn dilannenw fɔlenw ni sɛbɛnw cɛ minnu bɛ kɔrɔsi wa? |
| Fɛn dilannen ni minɛn dafalen | 15% ye . | Yala sistɛmu wajibiyalen dafalen don, a sɛbɛnnen don ani a bɛ se ka dɛmɛ wa? |
| Seko ni dɔnko ni jiginni | 15% ye . | Yala seko ni dɔnko, fɛnmarataw ani ɲɛminɛ waati ɲininiw bɛ dɛmɛ sɔrɔ sisan kunnafoniw fɛ wa? |
| Sɛbɛnni ni sugu kɔfɛ dɛmɛni | 15% ye . | Yala feerekɛla bɛ se ka dɛmɛ don mɔgɔ tɔgɔ sɛbɛnni, tenderi, ɲininkaliw ani fɛn caman Changement control la wa? |
| Jagokɛyɔrɔ fitinin | 10% ye . | Yala sɔngɔ, MOQ, sarali, IP ani waajulikɛyɔrɔ sariyaw bɛ sabati wa? |
Aw bɛ girinyaw ladilan ka kɛɲɛ ni aw ka sugu ni fɛn dilannenw farati ye. Sariyasunba, jogoɲumanya walima tuguni dɛsɛko gɛlɛn o dɛsɛ ka kan ka jate i n’a fɔ da, a man kan ka sara ni sɔngɔ dɔgɔman ye walima ni jate caman ye yɔrɔ wɛrɛ la.
Darapo bilenman minnu bɛ sɔrɔ tuma caman na ni u bɛ fɛnw doncogo dilabaga sugandi
Claims (fɔlikanw) minnu tɛ scope (dakun) ye
A dilabaga b'a fɔ ko 'FDA, CE ani ISO seereyaw' nka a tɛ se ka o fɔlen in siri sariya siratigɛ la, fɛn dilannen, modɛli ani sugu la.
Sɛbɛn minnu tɛ se ka sɛgɛsɛgɛ
Seereyaw nimɔrɔw, dilan jɛkuluw, donw walima fɛn minnu datugulen don, olu tɛ yen, u tɛ bɛn ɲɔgɔn ma walima u tɛ sɔrɔ walasa ka u yɛrɛ sɛgɛsɛgɛ.
Sani ka kɔn wajibiw ɲɛ
Quotation ferme bɛ di sani a dilabaga ka fɛn dilannenw cogoya, u foroko, sɛbɛnw ani u tɔgɔ sɛbɛnni magow dafa.
Sɛgɛsɛgɛli rapɔɔri minnu bɛ kɛ ni mɔgɔw bɛɛ ye
Rapportw tɛ modeli kɔrɔbɔlen, a labɛncogo, fɛɛrɛ, sɔnni sariyaw walima jɛɲɔgɔnya jira ni fɛn ɲininen ye.
A dilabaga tɔgɔ ma jɛya
Tɔgɔ minnu bɛ bɛnkansɛbɛn, seere, sɛbɛn, fatura ani banki jatebɔsɛbɛn kan, olu tɛ kelen ye ni ɲɛfɔli sɛbɛnnen tɛ.
Suguda kɔfɛ taabolo si tɛ yen
Dɛmɛ bɛ bɔ feerelikɛlaw ka ɲɔgɔnye kelen-kelen bɛɛ la sanni ka kɛ ɲininkali sɛbɛnnenw ye, CAPA, kɔlɔsili ani hakilijigin taabolo.
XC Medico ni a dilannikɛla tɔw bɛ se ka suma cogo min na
Aw bɛ o sɛgɛsɛgɛli sɛbɛn kelen kɛ XC Medico ni a dilannikɛla tɔw bɛɛ la minnu tɔgɔ sɛbɛnna. Foroba izini, jogoɲini ani fɛnw dilancogo ɲɛw bɛ se k’aw dɛmɛ ka ɲininkaliw labɛn, nka feerekɛlaw ka sɔnni ka kan ka sinsin sɛbɛnw kan minnu bɛ sen na sisan ani daliluw kan minnu bɛ tali kɛ aw ka fɛn dilannenw ni sugu la.
Fɛn nata min bɛ se ka kɛ, o ye k’i ka jamana laɲinitaw lisi labɛn, ka fɛn dilannenw sigicogo wajibiyalenw, komandi kɛcogo jateminɛlen, OEM wajibiyalenw ani sɛbɛnw matirili. A ɲini dilanbaga kelen-kelen bɛɛ fɛ u ka jaabi di cogo kelen na. O bɛ sɛbɛn dɔ bɔ min bɛ se ka suma ni jogoɲumanya, sariyaw ani jago seginnkanni ye.
XC Medico sosiyete ni a dilanni ɲɛfɔli. Baara kɛ ni wideyo ye walisa ka ɲininkaliw labɛn minnu bɛ tugu ɲɔgɔn kɔ; feerekɛlaw ka sɔnni dafa ni sɛbɛnw ye minnu bɛ kɔrɔsi sisan ani jatebɔ daliluw.
Ni aw ka jɛkulu bɛ ka fɛn dilanbaga dɔ bila a nɔ na min bɛ yen, aw bɛ baarakɛcogo faratiw fana lajɛ minnu ɲɛfɔlen don gafe kɔnɔ min bɛ wele ko... kolotugudaw dilanbagaw caman cili k’a sɔrɔ u ma u tilatilali tiɲɛ.
Ɲininkali minnu bɛ kɛ tuma caman na
Seere jumɛnw ka kan ka sɔrɔ kolotugudaw dilannikɛla fɛ?
Jaabi bɛ bɔ fɛn dilannen ni sugu laɲinilen na. ISO 13485 ye jogoɲumanya sariya ye min lakodɔnnen don kosɛbɛ furakɛli-minɛnw jɛkuluw fɛ, nka sannikɛlaw ka kan fana ka sariyaw lajɛ minnu bɛ fɛn kɛrɛnkɛrɛnnenw kan. Aw ye seereyaw hakɛ, yɔrɔ, sariya jɛkulu, fɛn dilannenw denbaya, u cogoya sisan ani suguya wajibiyalenw sɛgɛsɛgɛ.
Yala FDA tɔgɔ sɛbɛnni kɔrɔ ye ko fɛn dɔ dagalen don wa?
Ayi FDA b’a fɔ ko sigida tɔgɔsɛbɛnni ni minɛnw tɔgɔladonni tɛ a jira ko sigida walima a ka minɛnw sɔnna, u ma sɔn walima u ye yamaruya di u ma. Ni minɛn dɔ ka kan ka segin a kan sani a ka feere, aw bɛ sɛgɛsɛgɛli kɛ ni yamaruya, sɔnni walima yamaruya wɛrɛw ye minnu bɛ tali kɛ o la.
Jagokɛla bɛ se ka ISO 13485 seereyaw sɛgɛsɛgɛ cogo di?
Aw ye seere nimɔrɔ, sariyatigi, yɔrɔ ladɛrɛsi, baara minnu bɛ dafa, fɛn dilannenw hakɛ, seereyaw jɛkulu ani u baara donw lajɛ. Aw bɛ seere in dafa ni seere dibaga walima seereyaw dibaga ye ni a bɛ se ka kɛ, ani ka a lajɛ ni jogoɲumanya sira bɛ waleya tiɲɛ na sɛbɛnw lajɛli waati walima jatebɔ waati.
Sɛbɛn jumɛnw ka kan ka lajɛ sani i ka komandi kɛ?
Dalilu minnu bɛ sɔrɔ cogoya la, olu ye sosiyete ni fɛn dilanni yɔrɔ kunnafoniw ye, ISO 13485 hakɛ, fɛn kɛrɛnkɛrɛnnenw suguya sɛbɛnw, fɛnw ni kuluw nɔfɛta misaliw, dantigɛli walima sɛgɛsɛgɛli dalilu minnu bɛ se ka sirataama, taamasiyɛnw, cikanw, fɛnw dilancogo sariyaw, ɲininkali kɛcogo ani fɛn caman sɛgɛsɛgɛli kunkanbaaraw. Lisiti tigitigi ka kan ka sigi jogoɲumanya ni sariyasunba baarakɛlaw fɛ minnu bɛ se kosɛbɛ.
Danfara jumɛn bɛ fɛn donta dilannikɛla ni a feerela cɛ?
Dilanbaga dɔ bɛ fɛn dilanni baara kɛ walima k’a kɔlɔsi, wa a bɛ se ka dilancogo ni sariyako kunkankow fana ta. Fɛn dilanbaga bɛ se ka kɛ fɛn dilannikɛla ye, fɛn dilannikɛla, fɛn feerela walima jagokɛla. Sannikɛlaw ka kan ka tɔn kelen-kelen bɛɛ jɔyɔrɔ sɛbɛnnen dɔn sanni u k’u jigi da jago ɲɛfɔli dɔrɔn kan.
Yala sɔngɔ ka kan ka kɛ sariyaba ye ni i bɛ fɛn dilannikɛla dɔ sugandi wa?
Ayi, sɔngɔ ka kan ka jateminɛ ɲɔgɔn fɛ ni sariyaw bɛnkan ye, jogoɲumanya daliluw, tugucogo, fɛn dilannenw dafalen, seko, fɛnw lasecogo dannaya, sɛbɛnw, sugu kɔfɛ dɛmɛ ani bɛnkansɛbɛn sariyaw. Sɔngɔ fɔlɔ dɔgɔyali bɛ se ka kɛ sababu ye ka mɔgɔ tɔgɔ sɛbɛnni, fɛnmaracogo walima jogoɲumanya musakabaw lase kɔfɛ.
Aw bɛ fɛn dilannikɛla ka dantigɛli pake dɔ ɲini
Aw ka sugu laɲinitaw, fɛn dilannenw suguya, komandi kɛcogo makɔnɔnen ani OEM wajibiyalenw tila ɲɔgɔn na. Aw ye sɛbɛn pake dɔ ɲini, aw ka jogoɲini, sariyasunba ani sannifeere jɛkuluw bɛ se ka min lajɛ sani aw ka taa misaliw la walima jago yamaruya dɔ la.
Aw ye kuma XC Medico fɛReferences réglementaires officielles (Sɔrɔdasi sariyasunw).
Baarakɛlaw ka baarakɛcogo kunnafoni: Nin barokun in dabɔra ka jagokɛlaw ni jagokɛlaw ka sɛgɛsɛgɛli kɛcogo ɲuman dɛmɛ. O tɛ dɔgɔtɔrɔso ladilikan ye, sariya ladilikan tɛ walima a latigɛ ko fura kɛrɛnkɛrɛnnen dɔ yamaruyara sugu kɛrɛnkɛrɛnnen dɔ kama. Sariyasunw ni jogoɲumanya wajibiyalenw bɛ danfara ka kɛɲɛ ni minɛnw ye, baarakɛcogo laɲinitaw ani sariyasunw; aw bɛ ladilikan di baarakɛlaw ma minnu bɛ se kosɛbɛ sani aw ka sɔnni walima sanniko latigɛ.
