Trauma Implants OEM: Alesi Nàwɔ Distal Tibiofibular Locking Plate Si Dzi Mamalawo Ate Ŋu Aka Ðe

Ne ènye mamala si le Trauma Implants OEM dɔwɔhati aɖe me tom la, akpa si sesẽ wue nye be nàke ɖe dɔwɔƒe si ate ŋu awɔ mɔ̃ na agbalẽvi aɖe ŋu o.

Enye ɖeka didi si ate ŋu awɔ ŋutilã ƒe wɔwɔme ƒe ʋuƒo sesẽ aɖe enuenu, aŋlɔe ɖi dzadzɛ, eye wòaɖoe ɖa kakaɖedzitɔe—'nukunuwo' manɔmee ne èdze ŋkɔ ŋɔŋlɔ, dɔbiagbalẽvi, alo agbalẽdzikpɔkpɔ dzadzraɖo gɔme.

Nya sia gblẽ alesi 'nyui' le me zã distal tibiofibular locking plate (zi geɖe la, woƒoa wo nu ƒu kple distal fibula/ankle locking plate ƒomewo) abe duƒuƒu ƒe kpɔɖeŋu ene—elabena eƒoa lãmeka falɛfalɛ tsɛwo ƒe nutsyɔtsyɔ, mɔɖeɖe ɖe nu ŋu sesĩe, kple locking-hole ƒe nyonyome nu ƒu le mɔ si ɖea adzɔnuwo wɔwɔ ƒe ɖoɖo siwo gbɔdzɔ la fiana kabakaba nu.

Nu vevi siwo woatsɔ ayi teƒe bubuwo

• 'perfect' distal tibiofibular locking plate menye asitsatsa ƒe nyawo ŋu nya o. Eku ɖe fit, locking-interface quality, ɖeɖiteameŋu-afɔku dzi ɖuɖu, kple traceability ŋu.

• Ele be wò nudzrala nate ŋu aɖe alesi wokpɔa ŋusẽ ɖe TC4 titanium (Ti-6Al-4V) , mɔ̃wo, ewuwu, dzadzɛnyenye, kple ŋkuléle ɖe eŋu dzi me (eye woaŋlɔe ɖi)—nu geɖe ɖe wo nɔewo yome.

• Le xexeame katã ƒe asiwo gome la, laser dzesidede + UDI traceability engraving kple clean packaging menye 'nice to have'—wonye gɔmedzedze.

• Ne èdi be yeaʋuʋu kabakaba la, MOQ sesẽ 10 sets ate ŋu anye wò lever sesẽtɔ kekeake be nàɖo kpɔɖeŋuwo kple PO gbãtɔ evɔ màtsɔ afɔku si dzi womate ŋu alɔ̃ ɖo o.

Nusi wòle be distal tibiofibular locking plate nawɔ (le Eŋlisigbe si me kɔ me) .

Bu agbalẽvi si wotsɔ xea mɔ na nu abe 'nuƒomɔ̃ ƒe nuwɔna si sɔ pɛpɛpɛ ene.' Agbalẽvi la le vevie—gake agbalẽvi + gavi ƒe ƒomedodoe nye ɖoɖo ŋutɔŋutɔ.

That’s why major ankle/fibula plate systems emphasize features like low-profile titanium plates , anatomically contoured shapes , kple ʋuƒoƒo ƒe tiatia deŋgɔ siwo wowɔ be woatsɔ ana fixation nanyo ɖe edzi esime woɖea lãmeka falɛfalɛwo ƒe dzikudodo dzi kpɔtɔna (kpɔ Zimmer Biomet ƒe ALPS Fibula Plating System ŋuti nyatakaka kpui).

Ne èse 'distal tibiofibular locking plate,' zi geɖe la, èle plate ƒome aɖe si hiã be wòatsɔ nu ene ana ɣesiaɣi la me dzrom—vevietɔ ne èle distal tibiofibular locking plate wɔla aɖe dom kpɔ hena ɖoɖo aɖe si ŋu ame ŋutɔ ƒe ŋkɔ le:

1) Anatomical contour si sɔ mawɔmawɔ aggressive bending

'Anatomically contoured' menye nya si me mekɔ o o—enye dodokpɔ si woate ŋu agbugbɔ awɔ.

Ne contour ƒe nyateƒetoto trɔ le lotawo dome la, èkpɔa kuxi siwo le anyime: ɣeyiɣi didi OR ɣeyiɣi didi, lãmeka falɛfalɛwo ƒe nyatoƒoetoto, plate ɖoɖo si mewɔ ɖeka o, kple tɔtrɔgbɔ/nyatoƒoetoto ƒe afɔku si lolo wu.

Key Takeaway : Le agbalẽvi ƒomevi sia gome la, ewɔwɔ ƒe taɖodzinu menye 'àte ŋu awɔe zi ɖeka?' Enye 'àte ŋu alé contour la ɣesiaɣia?' o.

Be woakpɔ alesi ɖoɖo veviwo ɖɔa nudidi siae la, Zimmer Biomet tsɔa ALPS Fibula Plating System ɖoa teƒe si le tẽe ƒoa xlã distal fibula solutions siwo ƒe nɔnɔme mede ame dzi o, siwo ƒe ŋutilã ƒe nɔnɔme wowɔ.

2) Low profile, elabena lãmeka falɛfalɛwo ƒe nutsyɔtsyɔ seɖoƒe li na

Distal fibula/ankle nutowo me lãmenugbagbeviwo mexea nu boo aɖeke o. 'Low profile' nyea aɖaŋuwɔwɔ ƒe nudidi vevi zi geɖe le ɖoɖo ƒe gbe me (agate ŋu akpɔ 'low profile' ƒe gbeteteɖedzi le Zimmer Biomet ALPS fibula system ƒe axa dzi).

Le OEM ƒe nukpɔsusu nu la, aɖaŋu siwo mebɔ o doa nuwo wɔwɔ ƒe sesẽ ɖe dzi elabena goawo, woƒe didime, kple woƒe nuwuwu ƒe gbɔdzɔgbɔdzɔwo va dzena le atikewɔnyawo me wu eye woate ŋu ahe nyatoƒoetoto vɛ.

3) Distal locking cluster si léa kakɛ suewo

Distal fibula plate ƒome geɖe zãa distal cluster si me do geɖe le. Alesi woɖɔ esia le asi me ƒe kpɔɖeŋu nyui aɖee nye Orthobullets ƒe numeɖeɖe tso distal lateral fibula plate si me '7 hole distal cluster' le si xɔa variable-angle locking screws eye wòtea gbe ɖe dzikudodo dzi ɖeɖe kpɔtɔ dzi esime wole kakɛwo lém (kpɔ Pangea Distal Lateral Fibula plate ƒe axa).

4) Locking-hole quality (elabena 'locking' menye tsɔtsɔke o)

Do siwo wotu la naa afɔku si le adzɔnuwo wɔwɔ me:

• ka ƒe nɔnɔme kple eƒe anyigba ƒe blibonyenye

• dzogoe dzi nyateƒetoto le mɔzɔzɔwo me

• burr dzi ɖuɖu

• gbugbɔgawɔ le dɔwɔnuwo kple hatsotsowo me

Le mamalawo gome la, esia gɔmeɖeɖe zua agbalẽdzikpɔkpɔ ƒe nyabiase ɖeka:

Pro Tip : Bia OEM alesi woɖoa kpe locking-hole quality dzi— menye dimensions ɖeɖeko o , ke boŋ interface performance, tool-wear controls, kple acceptance criteria.

Trauma Implants OEM wɔwɔ ƒe sisi (si nye 'na wòasɔ' ƒe ɖoɖo)

A sesẽ Trauma Implants OEM hadɔwɔla ate ŋu azɔ wò to bliboe wɔwɔ kple asiɖeɖe le sisi maɣla eɖokui ɖe generic asitsatsa megbe.

Le ete la, ɖoɖo si sɔ si wòle be nàkpɔ mɔ na na titanium-ʋuƒo si me nu sesẽwo le lae nye esi.

(Ne ènye ame yeye le nudzralawo ƒe numekuku me la, woɖoe be akpa sia nawɔ zi gbɔ zi eve abe Eŋlisigbe me numedzodzro si me kɔ le ƒumeŋuɖui ƒe nuveviwɔame ƒe OEM wɔwɔ ŋu ene .)

Afɔɖeɖe 1: Dze egɔme kple titanium si sɔ si woate ŋu ade ame me (TC4 / Ti-6Al-4V) .

Le nuveviwɔame ƒe agbawo gome la, titanium si woate ŋu ade ame me ye nye nusi wozãna ɖaa le ɖoɖo geɖe me; le kpɔɖeŋu me, Zimmer Biomet yɔ agbalẽvi ƒe nuawo tẽ be 'Ti-6Al-4V ELI' na eƒe ALPS fibula gbadzɛwo.

Wò MOQ, ɣeyiɣi si nàtsɔ akplɔe, kple asixɔxɔ mele vevie ne OEM mate ŋu akpɔ ŋusẽ ɖe edzi o:

• nusiwo wotsɔ wɔe ƒe ɖaseɖigbalẽ kple lot traceability

• chemistry/mechanical nunɔamesiwo ŋuti nuŋlɔɖiwo

• ŋkuléle ɖe ame ŋu si vaa eme kple vovototodedeameme

Womate ŋu awɔ ɖoɖo ɖe ɖoɖo sia ŋu o: ele be woaɖo nusiwo wotsɔ dea ame me ɖe teƒe si nye TC4 titanium (Ti-6Al-4V) ƒe atikewɔwɔ ƒe dzeside.

Ne èle agbalẽvi sia zãm abe dzidzenu ene la, na wòadze ƒã le wò nudidiwo me: èle Ti-6Al-4V (TC4) titanium locking plate program dim tsoƒe, ke menye 'titanium-like' teƒenɔla o.

Afɔɖeɖe 2: Precision CNC machining si dea bubu ŋutilã ƒe wɔwɔme kple locking interfaces

Anatomic plate geometry plus locking-hole quality nye afisi ŋutete ɖenɛ fiana le.

Alesi 'nyui' le:

• li ke, mɔ̃ɖaŋununya ƒe ɖoɖo siwo ŋu woda asi ɖo na nɔnɔme veviwo (do siwo wotu, distal cluster, plate contour surfaces) .

• dɔwɔnu ƒe vuvu dzi kpɔkpɔ si dzi wokpɔna be woaƒo asa na ʋuʋu

• mɔzɔzɔ siwo woate ŋu agbugbɔ awɔ (eyata ƒuƒoƒoa wɔa nu ɖekae le lotawo katã me) .

Afi sia hãe wòle be nudzrala aɖe ƒe 'míate ŋu awɔ 5-axis' ƒe nyagbɔgblɔ nazu nusi woate ŋu adzidze: mɔ̃wo, nusiwo wotsɔna léa nu, kple ŋkuléleɖenuŋu ƒe ɖoɖo siwo ɖea gbugbɔgawɔ fiana—menye dɔwɔnuwo ƒe xexlẽdzesiwo ɖeɖeko o.

Afɔɖeɖe 3: Deburring kple edge finishing nye ɖeɖiteameŋu kple nyatoƒoetoto dzi ɖuɖu

Le agba siwo mebɔ o gome la, menye atsyɔ̃ɖoɖoe wotsɔ wu enu o. Ekpɔa ŋusẽ ɖe:

• lãmeka falɛfalɛwo ƒe dzikudodo (nyatoƒoetoto) .

• nusuekpɔmɔ̃ ƒe afɔku

• ɖeɖiteameŋu ƒe dɔwɔwɔ (micro-notches ate ŋu anye nu vevi) .

Bia be yeakpɔe ɖa be:

• wuwu ƒe dzidzenu siwo dzi woato axɔe

• ŋkuléle ɖe nu ŋu ƒe dzidzenuwo

• kpɔɖeŋu foto siwo gblẽ le wo ŋu kple hatsotsowo me toto ƒe sewo

Afɔɖeɖe 4: Dzadzɛnyenye kple ɖiƒoƒo dzi ɖuɖu hafi nàblae

Ele be OEM si dzi woate ŋu aka ɖo nate ŋu aɖe woƒe dzadzɛnyenye dzi kpɔkpɔ (kple, le afisi wòsɔ le, kpeɖodzimɔnu) me le mɔ si ato ŋkuléle ɖe nu veviwo ŋu me.

Nusiwo ŋu nètsia dzi ɖo abe numamãla ene:

• nusiwo susɔ (fafanuwo, amiwo) kple nusuewo menye 'kuxi suewo' le ŋkɔ ŋɔŋlɔ kple agbalẽdzikpɔkpɔ me o

• ele be dzadzɛnyenye kple eŋudɔwɔwɔ nado alɔ nubablɛwo ƒe nyonyome si mewɔa tɔtrɔ o

Afɔɖeɖe 5: Dzodzro, dodokpɔ, kple 'vɔ̃ɖitɔ kekeake' susu

Le TOFU ƒe afɔɖeɖe me gɔ̃ hã la, enyo be míase ɖoɖowɔwɔ ƒe susu ɖeka gɔme elabena eʋãa alesi nudzrala tsitsiwo bua tamee:

FDA ƒe mɔfiame na ƒumeŋuɖui ƒe gbagbã ƒe agbalẽviwo te gbe ɖe agbalẽvi siwo ƒe nɔnɔme gblẽ wu tiatia dzi na ŋutilã ƒe akpa ɖesiaɖe hena mɔ̃ɖaŋununya dodokpɔ (kpɔ FDA PDF Orthopedic Fracture Fixation Plates ƒe mɔfiame).

Mehiã be nànye dodokpɔwɔƒe hafi azã gɔmesese sia o. Ðeko wòle be nàbia be:

• 'Nuɖoɖo kae nye wò vɔ̃ɖitɔ kekeake na agbalẽvi ƒome sia—eye nukatae?'

• 'Kpeɖodzi kae le asiwò na nɔnɔme vɔ̃ɖitɔ ma?'

⚠️ Nuxlɔ̃ame : Ne nudzrala aɖe ɖe 'dzedzeme nyui' kpɔɖeŋu ɖeka ko fia eye mete ŋu ɖe tiatia vɔ̃ɖitɔ kekeake me o la, bu ema abe tsitsi ƒe aflaga dzĩ ene.

Nudidi siwo sɔ na asi siwo mele be mamalawo naɖe asi le wo ŋu o

Laser dzesidede + UDI traceability nuŋɔŋlɔ

Le asi siwo me wowɔa sewo dzi le wu gome la, èdi be dɔwɔƒea nado alɔ:

• atikewɔwɔ ƒe dzeside si wotsɔ laser wɔe

• blibo UDI traceability code nuŋɔŋlɔ

Le nyateƒe me la, esiae nye UDI laser dzesidede ƒumeŋuɖui siwo wotsɔ dea lãme na ame ƒe hiahiã: ŋutete si le ame si be wòade dzesi mɔ̃wo ahalé ŋku ɖe wo ŋu ɣesiaɣi, woaxlẽ wo, eye woate ŋu alé ŋku ɖe wo ŋu.

Menye dzesideŋkɔ ƒe nɔnɔme koe esia nye o—enye nuzazãwo ƒe kɔsɔkɔsɔ dzi kpɔkpɔ. Ebla wò nyatoƒoetotowo gbɔ kpɔkpɔ eye wòtrɔna yia nuwɔƒe aɖe eye mlɔeba la, egatrɔna yia nu xoxowo ƒe teƒewo.

Dzadzɛxɔ me ʋuʋudedi ƒe bablawo + Gamma/EO dɔlékuiwutikewo dzikpɔkpɔ

Eɖanye be woɖo atike mamlɛtɔ si me dɔlékui mele o alo esi me dɔlékui mele o o, ele be OEM ƒe ŋutete nalɔ:

• cleanroom blister packaging (wotre nu, ametakpɔnu, ɣesiaɣi) .

• Gamma/EO ƒe vidzidzi dzikpɔkpɔ ƒe ŋutete

Esiae nye vovototo si le 'míateŋu aɖo akpa aɖewo ɖe meli' kple 'míateŋu ado alɔ ɖoɖo si wowɔna tsɔ dea ame me.' dome.

ISO 13485 + CE—kple dossier ƒe kpekpeɖeŋu na LATAM asiwo

Ðaseɖigbalẽwo menye nyagbɔgblɔ o. Biabia si le mamalawo domee nye: ɖe OEM ate ŋu ado alɔ agbalẽwo kple amehehe si hiã hena asitsatsa me yiyia?

Ne mede ɖeke o la, ele be ɖoɖowɔɖi sia nabla ɖe:

• ISO 13485 ƒe nyonyome ƒe ɖoɖo ƒe mɔkpɔkpɔwo

• CE-aligned nuŋlɔɖiwo ƒe amehehe

Eye le LATAM ƒe taɖodzinuwo gome la, ele be wò OEM nanɔ klalo be yeado alɔ ŋkɔ ŋɔŋlɔ ƒe mɔ̃ɖaŋu ŋuti nyatakakawo abe hadomeɖoɖoa ƒe akpa si woɖo ɖi ene.

Asitsaha la lever akpa gãtɔ OEMs underuse: a sesẽ 10 ɖo MOQ

Ne èle ka yeye tum alo le OEM yeye dom kpɔ la, duƒuƒu le vevie.

Menye asitsatsa ƒe nuzazã dzro aɖe koe le sesẽe MOQ si me wowɔa nu 10 nye o—enye dɔwɔnu si wotsɔ kpɔa afɔkuwo gbɔe:

• àte ŋu ada alesi wòsɔ/wu enu/de dzesii/nubablɛwo kpɔ kaba

• àte ŋu aɖo kpe nuŋlɔɖi ƒe dɔwɔwɔ ƒe ɖoɖowo dzi hafi atsɔ ɖokuiwò ana ɖe nudzraɖoƒe gãwo ŋu

• àte ŋu atso mɔa dzi ayi tender gbãtɔ alo amekola ƒe dodokpɔ ƒe ɖoɖo

Ne èdi susu si le alesi MOQ sue aɖe wɔa nudɔdɔ gbãtɔwo kabakabae ŋu la, mɔfiame ememetɔ sia nye nufiame si ŋu viɖe le: Dze Wò Ƒumeŋutinunya ƒe Adzɔnu Dzedze gɔme kple 10-Set MOQ.

OEM ƒe ɖaseɖigbalẽ si sɔ na mamalawo (nusi nàbia hafi axɔ kpɔɖeŋu) .

Na wòanɔ bɔbɔe. Hafi nàbia kpɔɖeŋuwo na distal tibiofibular locking plate program la, bia be:

1. Nusiwo wotsɔ wɔe ƒe nyagbɔgblɔ : TC4 titanium (Ti-6Al-4V) + kpɔɖeŋu nusiwo wotsɔ wɔe ƒe ɖaseɖigbalẽwo

2. Traceability kpɔɖeŋu : kpɔɖeŋu na lot xexlẽdzesi + UDI dɔwɔwɔ + laser dzesi kpɔɖeŋu fotowo

3. Adzɔnuwo wɔwɔ ƒe wɔwɔfia : mɔ̃ɖaŋudɔwɔwɔ + nuwuwu + dzadzɛnyenye + ŋkuléleɖenuŋu ƒe sisi (axa ɖeka)

4. Kpeɖodzi si wokpɔ le ŋkuléle ɖe nu ŋu : didime veviwo ƒe xexlẽdzesi + alesi woɖo kpe do si wotu ƒe nyonyome dzii

5. Packaging tiatia : cleanroom blister babla kpɔɖeŋu kple nɔnɔmewo

6. Sterilization dzikpɔkpɔ : Gamma/EO dzikpɔkpɔ ŋutete ƒe nyagbɔgblɔ (a kekeme, dziɖuɖuwo) .

7. Ðaseɖigbalẽwo : ISO 13485 kple CE ɖaseɖigbalẽwo + kekeme ƒe nyagbɔgblɔ

8. LATAM dossier support : nuŋlɔɖi siwo wonana zi geɖe hena ŋkɔ ŋɔŋlɔ

Ne èdi nuƒlebiabia bubu siwo nàte ŋu azã ake le nuveviwɔame ƒe ɖoɖowo katã me la, kpɔ: Nya 10 Siwo Ƒumeŋutinunyalawo Biana Ne Wole Nuveviwɔame ƒe Atikewɔƒewo Dim.

Nyabiasewo ƒe Nyabiasewo

1) Nukae nye wò MOQ na distal tibiofibular locking plate ɖoɖowɔɖi?

Le kpeɖodzinana geɖe siwo mamala kplɔ gome la, MOQ si ƒe hatsotso 10 nye gɔmedzedze nyui aɖe elabena enaa nètoa fit/finish, locking-hole interface, dzesidede, kple nuŋlɔɖiwo me hafi tsɔa ɖokuiwò nana be yeawɔ nudzraɖoƒe gãwo. Ne èhiã kpɔɖeŋu ƒe ɖoɖo bubu (le kpɔɖeŋu me, miame/ɖusime ƒuƒoƒo, didime siwo wotsaka), tsɔ ɖoɖowɔɖi ƒe xexlẽdzesi tututu sɔ kple wo nɔewo le nuŋɔŋlɔ me hafi nàwɔ PO gbãtɔ.

2) Nukae nèhiã tso mía gbɔ be míadze kpɔɖeŋuwo gɔme kaba?

Be nàʋuʋu kabakaba evɔ mawɔ nuku na wò le nɔnɔme nyui me o la, dzra ɖo ɖe:

• nutata alo nusi wowɔ ƒe spec gbalẽvi (alo wò taɖodzinu ƒe agbalẽvi ƒe ƒome ƒe xexlẽdzesi) .

• wò asi(wo) si nèɖo taɖodzinu na kple ŋkɔ ŋɔŋlɔ ƒe mɔnu (le kpɔɖeŋu me, CE, nutoa me LATAM ƒe nudidiwo) .

• dzesidede/traceability ƒe nudidiwo (lot code, UDI, gbegbɔgblɔ) .

Emegbe ele be OEM naɖo kpe edzi: lead time , critical dimensions , inspection plan , kple nusi woatsɔ ana le kpɔɖeŋu pack (certs, nyatakakawo, fotowo).

3) Titanium grade kae wòle be míagblɔ na agbalẽvi siawo?

Le nuveviwɔame ƒe agbalẽvi sia ƒomevi gome la, gblɔ TC4 titanium (Ti-6Al-4V) si me nudidi siwo me kɔ le na nuwo ƒe ɖaseɖigbalẽ, lot traceability, kple incoming inspection controls. Ne èdi be yeakpɔ ELI ƒe dzeside (si woyɔna zi geɖe le asi me) la, gblɔe tẽ le RFQ ƒe afɔɖeɖea me ale be OEM nate ŋu atrɔ asi le nuwo ƒe dzɔtsoƒe kple nuŋlɔɖiwo ŋu.

4) Ðaseɖigbalẽ kawoe le vevie wu ne èle Trauma Implants OEM tiam?

Ne mede ɖeke o la, ele be nàkpɔ mɔ na ISO 13485 ƒe nyonyome dzikpɔkpɔ ƒe ɖoɖo si axɔ afisi wòsɔ ɖo (nu siwo wotsɔ dea ame me kple/alo dɔwɔnuwo). Le asi geɖe gome la, nuŋlɔɖiwo ŋuti amehehe si sɔ ɖe CE nu hã le vevie. Ne èle taɖodzinu ɖom ɖe US ŋu la, de dzesii be FDA 510k nye atike tɔxɛ , eyata bia alesi OEM doa alɔ wò dɔdɔ ƒe agbalẽvi (le kpɔɖeŋu me, dodokpɔ ƒe kpekpeɖeŋu, kplɔkplɔ, kple nuŋlɔɖiwo ƒe dzadzraɖo) tsɔ wu be nàtsɔe be 'dɔwɔƒe 510k.'

5) Aleke míewɔna ɖoa kpe locking-hole ƒe nyonyome dzi wu dzidzeme bɔbɔewo?

Bia kpeɖodzi be nudzrala la kpɔa ʋuƒoƒo ƒe ŋgɔdonyawo dzi abe ɖoɖo ene, siwo dometɔ aɖewoe nye:

• nu veviwo me dzodzro (ka ƒe nɔnɔme, anyigba ƒe blibonyenye, mɔzɔzɔ/dzogoe) .

• dɔwɔnu ƒe dodo dzi kpɔkpɔ kple lɔlɔ̃ ɖe edzi ƒe dzidzenuwo

• go/no-go alo dɔwɔwɔ ƒe ŋgɔdonya ƒe dodokpɔwo le afisi wòsɔ le

Bia hã be woaŋlɔ kpɔɖeŋuwo me dzodzro ŋuti nuŋlɔɖiwo kple nɔnɔme madeamedziwo ƒe hatsotso ƒe dzidzenu si me kɔ na burrs, ka ƒe gbegblẽ, kple anyigba ƒe nɔnɔme gbegblẽwo.

6) Dzodzro ƒe nuŋlɔɖi kawoe wòle be woatsɔ kpɔɖeŋuwo akpe ɖe eŋu?

Zi geɖe la, kpɔɖeŋunu sesẽ aɖe ƒe akpa aɖewoe nye:

• nu ƒe ɖaseɖigbalẽ ƒe kpɔɖeŋuwo kple lot traceability statement

• nyatakaka si wotsɔ léa ŋku ɖe nu veviwo ŋu (si me wodzidze emetsonuwo le, ke menye ɖaseɖigbalẽ dzro aɖe ko o) .

• foto siwo ɖe do siwo me wodoa ga le ƒe ƒuƒoƒoa kple eƒe go siwo wowu enu la fia

• dzesidede/traceability ƒe kpɔɖeŋuwo ne ehiã (lot code, UDI workflow) .

Ne OEM mate ŋu ana esiawo na kpɔɖeŋuwo o la, enye dzesi be wò agbalẽdzikpɔkpɔ gbãtɔ ate ŋu asesẽ wu alesi wòhiã.

Afɔɖeɖe siwo kplɔe ɖo

Ne èle Trauma Implants OEM hadɔwɔlawo me dzrom eye nèdi be yeawɔ yeƒe ememe agbalẽdzikpɔkpɔ ɖe ɖoɖo nu la, tu dɔwɔnu sia si keke ta wu la ɖo: Mɔfiame Mlɔetɔ: Trauma Locking Plates Dɔwɔƒe.

Àdi be yeawɔ ɖaseɖigbalẽ si woate ŋu awɔ kɔpi na yea? Ðo eŋu kple wò asi si nèɖo taɖodzinu na (US-ko vs US + LATAM) eye mawɔ esia ɖe axa ɖeka ƒe OEM ƒe dodokpɔ gbalẽvi si nàte ŋu ama kple wò ƒuƒoƒoa me.

Dɔwɔnu bubu si do ƒome kplii (ne èle nuveviwɔame ƒe fli blibo tum ɖo): Trauma Implant Dɔwɔƒewo na Mamãlawo.