2026 sannikɛla ka gafe · Kolotugudaw feerela ka setigiya
Ka sugandi, kolotugudaw dilanbaga o ye jogoɲumanya ni tɛmɛsira desizɔn ye—a tɛ sɔngɔ suma dɔrɔn ye. San 2026 kɔnɔ, sannikɛlaw ka kan ka sisan sariyaw labɛncogo jateminɛ, ka sɛbɛnw sɔrɔ fɛn dilannenw kan, ka tugu ɲɔgɔn kɔ, ka fɛn dilanni kɔlɔsili, ka fɛnw lase daliluw, ka dɛmɛ don ɛntɛrinɛti la, ani ka jaabi di sugu kɔfɛ. Nin gafe in bɛ o wajibiw sɛmɛntiya ka kɛ sariya wolonwula ye, min bɛ kɛ ni fɛn 100 ye, min bɛ kɛ ka fɛnw dilan.
Aw ka kan ka kolotugudaw dilanbagaw jateminɛ cogo di san 2026 kɔnɔ?
Baara kɛ ni fɛɛrɛ ye min sinsinnen bɛ faratiw kan, ni layini naani ye: ka kɔn ka sɛgɛsɛgɛli kɛ, sɛbɛnw sɛgɛsɛgɛli, misali walima piloti tiɲɛni, ani baarakɛcogo kɔlɔsili min bɛ senna. Aw ye yɔrɔ wolonwula jate, nka aw bɛ sariya siratigɛ la, fɛn dilannenw ka yamaruya, jogoɲumanya-sigida datugucogo, tugu-tugu-ɲɔgɔn kɔ, ani sɛbɛn nafamaw jate i n’a fɔ tɛmɛsira/dɛsɛ da.
Jaabi surun ɲuman : feerekɛla sugandi min bɛ se ka dalilu barikamaw di minnu sɛgɛsɛgɛra ka ɲɛsin fɛn dilannen tigitigi ma, a dilayɔrɔ, a taayɔrɔ sugu, ani a ka cakɛda jɔyɔrɔ ma—a kana kɛ feerekɛla ye min ka gafesɛbɛn janya ka bon walima min ka fɔta fɔlɔ ka dɔgɔ.
Mun de Changé furakɛli minɛnw feerelaw ka jateminɛ na san 2026 kɔnɔ?
San min bɛ tɔgɔ la, o ka kan ka bɛn sariyaw caman yeli lakikaw ma. Yiriwali fila bɛ nɔ bila kosɛbɛ kolotugudaw dilannikɛlaw la, fɛnw donbagaw la, u feerelaw la, ani u tɔgɔlafɛnw tigiw la san 2026 kɔnɔ.
FDA ka jogoɲumanya ɲɛnabɔcogo sariyasun
FDA ka jogoɲumanya sabatili sariyasun kɛra baarakɛcogo ɲuman ye, wa a bɛ ISO 13485:2016 don a kɔnɔ ka kɛɲɛ ni kunnafoni ye, ka fara Ameriki ka ɲinini kɛrɛnkɛrɛnnenw kan. FDA fana y’a daminɛ ka baara kɛ ni furakɛli-minɛnw sɛgɛsɛgɛli fɛɛrɛ kura ye. O la, Ameriki sugu ka setigiya ka kan ka QMSR waleyali sɛgɛsɛgɛ, a man kan ka ISO ka seere sɔrɔli dɔrɔn.
EUDAMED Module Naani fɔlɔw
EUDAMED ka modulu naani fɔlɔw kɛra wajibi ye: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, ani Market Surveillance. Seginkanni minnu sinsinnen bɛ EU kan, olu ka kan ka kɛ SRN, minɛnw ni UDI kunnafoniw, seereyaw labɛnni, ani sɔrɔko baarakɛla kelen-kelen bɛɛ ka kunkanbaaraw ye.
Danfara nafama : ISO 13485 seereyaw bɛ jogoɲumanya-sɛnɛcogo jateminɛ dɛmɛ, nka a tɛ yamaruya di fɛn bɛɛ ma min bɛ katalogu kɔnɔ. FDA sigili sɛbɛn kɔrɔ tɛ FDA ka sɔnni, a ka yamaruya, walima a ka yamaruya dilen ye. CE sɛbɛnw fana ka kan ka bɛn minɛn tigitigi ma, sariya dilabaga, danfara, kuntilenna laɲininen, ani bɛnkan sira min bɛ sirataama.
Baara kɛcogo ni nin kolotugudaw furakɛli jateminɛcogo ye
Sani aw ka kuma feerekɛlaw fɛ, aw bɛ fɛn dilannenw denbaya ɲɛfɔ, u baaracogo laɲininen, u taayɔrɔ suguya, u ka minɛnw danfara, u cogoya sterili walima u tɛ sterili, u hakɛ fɔcogo, u ka minɛnw wajibiyalenw, u ka baarakɛyɔrɔw, ani sɛbɛnw kunkankow. Fɛn dilanbaga tɛ se ka jateminɛ kɛ cogo bɛnnen na ka kɛɲɛ ni wajibi dɔ ye min ma ɲɛfɔ.
1Jogoɲumanya siratigɛ, sariyasunba cogoya, ani jatebɔ labɛnni
A daminɛ ni sariya siratigɛ la fɛn dilannikɛla dɔnni ye ani yɔrɔ bɛɛ min bɛ baara nafamaw kɛ. Aw ye a dɔn jɔn de bɛ dilancogo, masinw dilanni, finiw dilanni, saniya, pakew dilanni, sterilize, taamasiyɛnw, bɔli, ɲininkaliw ɲɛnabɔcogo ani sariyaw cicogo kɔlɔsi.
ISO 13485 seere min bɛ sen na sisan, o ɲini ani ka jɛkulu tɔgɔ, ladɛrɛsi, a bonya, seereyaw dibaga jɛkulu, a ka laseli, a ka seereyaw cogoya, ani a waati dafalen sɛgɛsɛgɛ. Ameriki ka fɛnw sɔrɔli kama, aw bɛ ɲininkali kɛ cogo min na a dilabaga ye QMSR ka sariyaw waleya. EU ka sɔrɔko kama, aw ka MDR cogoya min bɛ sirataama ani sɔrɔko-baarakɛlaw jɔyɔrɔw dafa.
XC Medico bɛ kunnafoni kunbaba dɔ bɔ a ka... kolotugudaw jogoɲini ni u sɛgɛsɛgɛli taabolo ; sannikɛlaw ka kan ka fɛn dilannenw ni yɔrɔ kɛrɛnkɛrɛnnenw sɛbɛnw ɲini hali bi setigiya waati.
2Inscription-Ready Fɛn dilannenw sɛbɛnw
A ka c’a la, jatebɔlaw tɔgɔ sɛbɛnni bɛ mɛn, o bɛ sɔrɔ sɛbɛnw dafalenbaliya fɛ, minnu tɛ bɛn ɲɔgɔn ma, walima minnu tɛ kɔrɔsi sanni ka kɛ ni u dilanni seko ye. Aw ye fɛn dilannenw denbaya kelen jateminɛ sanni aw ka sɔn layidu ma ko sɛbɛnw bɛ se ka da kɔfɛ.
- minɛnw ɲɛfɔli, u kuntilenna, u misaliw, u bonya, u ka fɛn dilannenw kode, ani u bɛnkan matiriyali;
- labeli ni baarakɛcogo misaliw ni seginnkanni kɔlɔsilen ani kan minnu bɛ tali kɛ u la;
- fɛnw ɲɛfɔcogo, fɔcogo, ani dalilu minnu bɛ tali kɛ biologiki-lakanani na;
- faratiw ɲɛnabɔli, sɛgɛsɛgɛli, tiɲɛni, ani kɛnɛyaso walima baarakɛcogo sɛbɛnw ni o bɛ se ka kɛ;
- sterilize, pakew, taa ni u ye, u mara waati, ani u baaracogo kura sɛbɛnw i n’a fɔ a bɛ se ka kɛ cogo min na;
- Deklarasiyɔn bɛ bɛn, seere, lisi, clearance, walima yamaruya sɛbɛnw minnu wajibiyalen don sugu laɲininen na.
Aw bɛ bɛn jaabi waati sɛbɛnnen kan min bɛ kɛ ka ɲɛsin aw tɔgɔ sɛbɛnni foroko kɛrɛnkɛrɛnnen ma. Aw bɛ dafalen, ɲɔgɔndan, seginnkanni kɔlɔsili ani tigiya suman—i kana teliya dɔrɔn.
3Traceability, UDI/EUDAMED Data, ani Yɛlɛma kɔlɔsili
Traceability system ka kan ka fɛn donta walima minɛn dafalen siri fɛnɲɛnamafagalanw na, a dilanni sɛbɛnw, sɛgɛsɛgɛliw, taabolo minnu bɛ kɛ kɛnɛma, taamasiyɛnw, pakew, sterilize yɔrɔ minnu na a bɛ se ka kɛ, ani a bɔli. Sistɛmu kɔrɔbɔ ni lot kelen sugandili ye ani ka ɲɛfɛ-ni-kɔfɛ-sira ɲini.
EU ka fɛn dilannenw kama, aw ye Actor, UDI/Device, seere, ani fɛn dilannikɛlaw ka kunnafoniw sɛgɛsɛgɛ EUDAMED modulu wajibiyalenw kɔnɔ. Sugu wɛrɛw ta fan fɛ, aw bɛ UDI tabaga, a bɔbaga, kunnafonidilan, ani sigida taamasiyɛnw wajibiyalenw sɛgɛsɛgɛ minnu ɲɛsinnen don o ma. UDI labɛnni ka ca ni laser taamasiyɛn ye : dantigɛli ni kunnafonidilan sɛbɛn ka kan ka bɛn minɛnw ɲɛmɔgɔ kunnafoniw ma minnu bɛ kɔrɔsi.
4Fɛn dilanni seko ni taabolo tiɲɛni
Fɛn dilannenw ka gafesɛbɛn t’a jira ko feerekɛla de bɛ taabolo minnu ɲɛnabɔ i ka minɛn kama. Fɛn min sugandira, o kariti kɛ ni masinw ye, foroko, funteni furakɛli, solda, polisi, passivation, coating, saniya, lajɛ, pakew, sterilize ani sɛgɛsɛgɛli laban. Aw ye a dɔn baara minnu bɛ kɛ so kɔnɔ ani minnu bɛ kɛ baarakɛlaw fɛ.
Segin ka kɛ fɛn dilanbaga ta ye orthopedic implant manufacturing capabilities , o kɔfɛ, aw bɛ u sɛgɛsɛgɛ ka kɛɲɛ ni minɛnw sɛbɛnw ye, baarakɛlaw ka sekow, taabolo tiɲɛni, u ladonni, u jateminɛcogo, u sɛgɛsɛgɛli fɛɛrɛw, u kɛcogo bɛnbaliya, ani batɛmu sɛbɛnw lakikaw.
Ni feerekɛla dɔ tɛmɛna wajibiya ka setigiya da la, aw bɛ quotations suma ni a ye farati ladilannen kolotugudaw feerela musaka misali sanni ka kɛ kelen sɔngɔ dɔrɔn ye.
5Waati ɲɛminɛni, Inventory ani Logistics Reliability
Layidu belebelebaw bila ɲɛfɔliw nɔ na minnu bɛ se ka suman. Aw ye seko nɔrɔlen ni seko bɛɛ lajɛlen ɲini, waati minnu bɛ kɛ ka kɛɲɛ ni fɛn dilannenw denbaya ye, komandi-dafa waati, komandi hakɛ fitininw, stock cogoya, kofɔlenw wajibiyalenw, fasa hakɛ walima OTIF jatebɔ, delay escalation, ani recovery plans.
Sigida marayɔrɔw bɛ se ka dɔ bɔ fɛnw falenni waati la, nka aw bɛ yɔrɔ ladɛrɛsi, SKU minnu maralen bɛ, fɛnw tigiya, kunnafonidi kɛcogo, segincogo, sigida kɔlɔsili, pakew dafalen kɔlɔsili, ani baarakɛyɔrɔ hakɛ bɛnkan sɛgɛsɛgɛ. Segin XC Medico ka bɔlenw kan kolotugudaw ka sɔrɔ-cakɛda ni fɛnmarayɔrɔ modɛli i n’a fɔ donta kelen, o kɔfɛ, baara kɛcogo daliluw ɲini kɔsa in na.
6OEM/ODM Ɛntɛrinɛti ani misali tiɲɛni
Ladamuni bɛ daminɛ ni mɔgɔ kelen-kelen ka pakew ye ka taa a bila fɛn kura doncogo walima minɛn kura la. Marka, set configuration, dimensions modification, ani fɛn kuraw yiriwali bɛ dilancogo kɔlɔsili ni sariyaw jateminɛni hakɛ danfaralenw de wajibiya.
Aw ye a dilabaga ta lajɛ kolotugudaw OEM/ODM dilanni baarakɛcogo . Gundo, dilancogo tigiyali, baarakɛminɛnw tigiyali, dilancogo dontaw, faratiw ɲɛnabɔli, ja, sɛgɛsɛgɛli, tiɲɛni, dilancogo jiginni, fɛn caman Changement control, ani sariyasunba kunkanbaaraw ɲɛfɔ sani i ka sɔn yiriwali ma.
Aw bɛ piloti dɔ boli min bɛ se ka kɔrɔsi. Misali bolodalen ka kan ka ja lajɛ, fɛnw, hakɛ kɔrɔw, baarakɛcogo ni ɲɔgɔndan sɛgɛsɛgɛliw, sɔnni sariyaw, misali hakɛ, ani misali dabɔlen bɛ kɛ fɛn dilanni ɲɛmɔgɔ ye cogo min na. Ladilikan wɛrɛw bɛ sɔrɔ tubabukan na koloci OEM/ODM sannifeere gafe.
7Minɛnw, Kalan, ɲininkaliw, ani sugu kɔfɛ dɛmɛ
Kolotugudaw doncogo bɛ se ka dɛsɛ baara la ni a minɛnw ma dafa, ni u tɛ bɛn ɲɔgɔn ma, ni u tiɲɛna, ni u tɛ sɔrɔ, walima ni u sɛbɛnnen tɛ. Aw bɛ sanubɔlan labɛncogo jateminɛ, minɛn ni fɛn donta bɛnkan, jate sɛbɛnw, baarakɛcogo kura cikanw, sɛgɛsɛgɛli sariyaw, fɛnw falenfalen, dilan siraw, fɛnw falenni, ani degeliw minɛnw.
Sugu kɔfɛ kunkanbaaraw ka kan ka ɲɛsin ɲininkaliw tali ma, ko juguw caya, sɛgɛsɛgɛli, sababu jujɔ sɛgɛsɛgɛli, CAPA, taabolo fɔli, foro kɔnɔ wale walima hakilijigin dɛmɛni, garanti, dilan, ani kumaɲɔgɔnya waatibolodacogo. Segin supplier ka sɛbɛnw kan feereli kɔfɛ ani ɲininkali-dɛmɛ taabolo , o kɔfɛ, ka kunkanbaaraw ɲɛfɔ jogoɲumanya walima fɛnw dilancogo bɛnkansɛbɛn kɔnɔ.
100-Point Orthopaedic Supplier ka jatebɔsɛbɛn
Aw bɛ jatebla kelen-kelen bɛɛ jate Bɔ 0 la ka Taa 5 la k’a caya n’a girinya ye. Dalilu minnu lajɛra, aw bɛ olu mara jateden kelen-kelen bɛɛ kɛrɛfɛ. Wajibiya dakunw ka kan ka tɛmɛ hali ni jateden bɛɛ lajɛlen ka ca.
| Criterion | Weight | Dalilu jɔnjɔnw | Da wajibiyalen don? |
|---|---|---|---|
| 1. QMS, sariyasunba cogoya, ani jatebɔ labɛnni | 20% ye . | Sariya siratigɛ la, yɔrɔw, ISO 13485 hakɛ, QMSR/MDR labɛnni, fɛn dilannenw ka yamaruya. | Awɔ |
| 2. Sɛbɛn minnu labɛnnen don ka i tɔgɔ sɛbɛn | 15% ye . | Dosiyɛri min bɛ kɔlɔsi, fɛn dilannenw ka kunnafonidilanw, labeliw, IFUw, sɛgɛsɛgɛliw, deklarasiyɔnw ani seereyaw. | Awɔ |
| 3. Traceability, UDI, ani fɛn caman Changement control | 15% ye . | Lot trace, UDI/device data, complaint linkage, marali, kiliyanw ladɔnniya. | Awɔ |
| 4. Fɛn dilanni ni taabolo tiɲɛni | 15% ye . | Taabolo taabolo, tiɲɛni, jateminɛ, sɛgɛsɛgɛli, feerekɛlaw ani sariya bɛnbaliya kɔlɔsili. | Ɔwɔ ka ɲɛsin scope ma |
| 5. Lase, fɛnw marali, ani fɛnw ladonni | 15% ye . | Lead times, capacity, stock, OTIF, escalation, transport ani tɛmɛsira daliluw. | Dantigɛ |
| 6. OEM injiniyɛri ani misali tiɲɛni | 10% ye . | Dilan kunkanbaaraw, ja, farati, sɛgɛsɛgɛli, misali ani dalilu fɔlɔw. | Porozɛ min bɛ tali kɛ a la |
| 7. Minɛnw ni sugu kɔfɛ dɛmɛ | 10% ye . | Sani kɔlɔsili, bɛnkan, kalan, ɲininkali, CAPA, dilan ani garanti. | Dantigɛ |
Dalilu sɔrɔli sɛgɛsɛgɛli
| Score | Dalilu hakɛ | Fasiri |
|---|---|---|
| 0 | Dalilu si tɛ yen | Wajibiya tɛ ɲɛnabɔ. |
| 1 | Kumakan dɔrɔn de fɔli | Markatɛri walima feereli fɔcogo min tɛ ni dɛmɛ kɔrɔsilen ye. |
| 2 | Dalilu dafalen tɛ | Sɛbɛnw kɔrɔlen don, u tɛ bɛn ɲɔgɔn ma, u ye fɛn bɛɛ ye, walima u ka key scope tɛ yen. |
| 3 | Dalilu minnu bɛ sɔn | Sisan sɛbɛnw minnu bɛ kɔrɔsi, olu bɛ o wajibi jira cogo bɛnnen na. |
| 4 | Dalilu barikamanw | Sɛbɛnw kɔnɔ, misali kɔsa in na, tugu-tugu-ɲɔgɔn kɔ, jateminɛw, ani tigiw minnu bɛ kunkanbaaraw la. |
| 5 | Dalilu minnu sɛgɛsɛgɛra | Dalilu bɛ tali kɛ fɛn dilannenw na, u bɛ se ka segin u kan, u bɛ dafa u yɛrɛma ni a bɛ se ka kɛ, wa u bɛ dɛmɛ ni kɔrɔsili ɲumanw ye. |
Sɔncogo sariya min bɛ se ka kɛ, o bɛ se k’a ɲini da wajibiyalenw bɛɛ fɛ ka tɛmɛ, sɔrɔ kɔrɔfɔlenw si ma ɲɛnabɔ, misali walima lot fɔlɔ min bɛ sɔn, ani jate girinman min ka ca ni sannikɛla ka dantigɛli ye min tun latigɛra ka kɔn. Dakun ka kan ka minɛnw farati ni jago gɛlɛya jira sanni ka kɛ diɲɛ bɛɛ ka jate ye.
Otomatiki Disqualification walima Escalation Drapeaux Rouges
Cogo min na ka o Framework kelen in waleya XC Medico kan
O jatebɔsɛbɛn kelen min sinsinnen bɛ daliluw kan, o ka kan ka kɛ kandida bɛɛ la, XC Medico fana sen bɛ o la. Sannikɛlaw bɛ se k’a daminɛ ni foroba nafolo ye min bɛ duguma, o kɔfɛ, u bɛ se ka sɛbɛnw ɲini fɛn dilannenw, suguw ani yɔrɔ kɛrɛnkɛrɛnnenw na walasa ka u sɛgɛsɛgɛ.
Gafew minnu bɛ tali kɛ fɛnw dilanbagaw ka jateminɛ na
- Ameriki kɛrɛnkɛrɛnnenw ka kolotugudaw ni minɛnw dilanbagaw ka sɛgɛsɛgɛli
- Orthopedia OEM/ODM sanni ni poroze bolodacogo
- Mun na margin fɔlɔw bɛ se ka feerekɛlaw ka musaka bɛɛ dogo
Ɲininkali minnu bɛ kɛ tuma caman na
Mun de jiginna kolotugudaw feerelaw ka jateminɛ na san 2026 kɔnɔ?
FDA QMSR daminɛna ka baara kɛ san 2026 feburuyekalo tile 2, wa a bɛ ISO 13485:2016 don a kɔnɔ ka kɛɲɛ ni Ameriki ka ɲinini kɛrɛnkɛrɛnnenw ye. EUDAMED modulu naani fɔlɔw kɛra wajibi ye kabini mɛkalo tile 28 san 2026. Sisan, feerekɛlaw ka seginnkanniw ka kan ka waleyali daliluw kɔrɔbɔ, u man kan ka ɲininkali kɛ dɔrɔn ni ISO walima CE sɛbɛnw bɛ tɔn dɔ bolo.
I bɛ se ka ISO 13485 seere dɔ sɛgɛsɛgɛ cogo di?
Aw ye jɛkulu tɔgɔ, a dilanyɔrɔ ladɛrɛsi, a bonya, seere nimɔrɔ, seereyaw dibaga jɛkulu, a ka laseli, a cogoya sisan, ani a waati tɛmɛnen lajɛ. Aw ye o kunnafoniw suma ni fɛn dilannen yɛrɛ ye, a tɔgɔ sɛbɛnnen, a jiracogo, a fɔcogo, ani a dilanni kunkanbaaraw.
Yala FDA tɔgɔ sɛbɛnni kɔrɔ ye ko kolotugudaw furakɛli minɛn dɔ sɔnna wa?
Ayi, FDA ka sigida tɔgɔsɛbɛnni ani minɛnw tɔgɔladonni kɔrɔ tɛ ko o yɔrɔ walima minɛn in sɔnna, ko a saniyalen don, walima ko yamaruya dira a ma. Aw bɛ minɛnw danfara tigitigi sɛgɛsɛgɛ ani sariya sira min bɛ sirataama.
Kolotugudaw dilanbaga ka kan ka sɛbɛn jumɛnw di?
Foroko wajibiyalen bɛ bɔ fɛn dilannen ni sugu la, nka a ka c’a la, fɛn dilannenw kunbaba kunnafoniw, fɛnw, ja, taamasiyɛnw, IFUw, faratiw ni sɛgɛsɛgɛli daliluw, sterilize ni foroko kunnafoniw bɛ sɔrɔ yɔrɔ minnu na, jiralifɛnw, seereyaw, ani fɛn kɛrɛnkɛrɛnnenw ka yamaruya sɛbɛnw bɛ sɔrɔ a kɔnɔ.
Yala a ka kan ka kɛ tuma bɛɛ ka fɛnw dilanbagaw ka jateminɛ kɛ yɔrɔ la wa?
Ayi, jatebɔ juguya ka kan ka kɛ faratiw de kan. Sɛbɛnw lajɛli, yɔrɔjan jateminɛ ɲɛnama, misali sɛgɛsɛgɛli, ani mɔgɔ wɛrɛw ka daliluw bɛ se ka kɛ sanni dɔw ye. Fɛnɲɛnɛmafagalan kura, minɛn sterili, taabolo kɔrɔw minnu bɛ kɛ ni baarakɛlaw ye, jogoɲumanya ko minnu bɛ segin-ka-bɔ, walima OEM porogaramu fɛɛrɛw bɛ se ka kɛ sababu ye ka jateminɛ kɛ yɔrɔ la.
Kolotugudaw furakɛlikɛlaw ka kan ka jate cogo di?
Aw bɛ baara kɛ ni dalilu 0–5 hakɛw ye minnu latigɛra ka kɔn ani sariyaw girinmanw. Aw ye sariyaw, sariya, tugu-tugu-ɲɔgɔn kɔ, ani jogoɲumanya wajibiyalenw mara i n’a fɔ dakun wajibiyalenw walasa sɔngɔ walima fɛnw lase jatew kana se ka sariya labatoli tununnenw sara.
Siɲɛ joli furakɛlikɛla min dagalen don, o ka kan ka segin ka jateminɛ kɛ?
Aw bɛ waati cɛmancɛ sigi ka kɛɲɛ ni minɛnw ni fɛnw sɔrɔli farati ye. Kɔlɔsili kɛ fiɲɛw, ɲininkaliw, CAPA, fɛnw dicogo, baarakɛcogo, sariyaw ni seereyaw cogoya, ani fɛn caman Changements continues. Gɛlɛyabaw walima fɛnbaw ka kan ka kɛ sababu ye ka seginnkanni kɛ ka kɔn o ɲɛ.
Kuncɛli
Kolotugudaw feerelaw ka jateminɛ min bɛ se ka lafasa, o bɛ feereli fɔlenw tigɛli kɛ dalilu ye min bɛ se ka tugu ɲɔgɔn kɔ. San 2026, o ye QMSR waleyali ye Ameriki suguba dilannikɛlaw ye ani EUDAMED labɛnni ye UE ka fɛn dilannenw na minnu bɛ se ka sirataama, ka fara fɛn dilannenw sɛbɛnni, u nɔfɛtaama, fɛn dilanni dafalenw, u dicogo dannamɔgɔ, yiriwali kɔlɔsili, ani sugu kɔfɛ dɛmɛni jɔnjɔnw kan. Baara kɛ ni jatebɔsɛbɛn kelen ye kandida kelen-kelen bɛɛ ye ani ka taa a fɛ ka baara kɛcogo suman sɔnni kɔfɛ.
Faamaw ka kunnafonidisɛbɛnw
- Ameriki FDA: Jogoɲumanya ɲɛnabɔcogo sariya (QMSR).
- Ameriki FDA: QMSR Ɲininkali minnu bɛ kɛ tuma caman na.
- Ameriki FDA: Sɛbɛnni ni minɛnw ka sɔnni, u ka yamaruya, walima u ka yamaruya.
- Erɔpu Komisiɔn : EUDAMED modulu naani fɔlɔw wajibiyalen don k’a daminɛ mɛkalo tile 28 san 2026.
- Duniya tɔnba min bɛ sariyaw sigi senkan: ISO 13485—Dɔgɔtɔrɔso minɛnw jogoɲumanya ɲɛnabɔcogo.
