Intramedullary Nail Manufacturers 15 minnu bɛ Ɛsipaɲi (2026 Sannifeere gafe)

Daminɛ kuma

Furakɛminɛnw sanniko siratigɛ la Ɛsipaɲi kolotugudaw la, o bɛ ka jiginni teliya la jɔcogo la. A bɛ boli ni musaka-dafalen yamaruya gɛlɛnw ye ka bɔ kɛnɛya minisiriso fɛ ( Ministerio de Sanidad ) ani bɔnɛba hakɛ minnu bɛ marabolow kɔnɔ, minnu bɛ mara sigida kɛnɛyaso yɛrɛmahɔrɔnyalenw fɛ ( Servicios de Salud Autonómicos )—i n’a fɔ SERMAS (Madrid), SAS (Andalucía), Catsalut (Cataluña), ani SACYL (Castilla y León), ka fara dɔgɔtɔrɔso jɛkuluba ɲɛmɔgɔw kan i n’a fɔ Quirónsalud ani Vithas—dɔgɔtɔrɔso sannifeere jɛkuluw bɛ fɛn minnu bila jɔyɔrɔ fɔlɔ la, olu bɛ fɛnw bila jɔyɔrɔ fɔlɔ la, minnu bɛ balansi ɲuman di kɛnɛyaso nafa, sariyaw lakanani, ani baarakɛnafolo kofɔlenw na.

Ni aw bɛ kolo karilen janw ɲɛnabɔ, ka wuluwulu jɛɲɔgɔn ɲuman sugandi opereli kɔfɛ gɛlɛyaw la ani ka sigida musakaw ɲɛnabɔ Licitaciones Públicas (Public Tenders) hukumu kɔnɔ. Nin gafe in bɛ wuluw dilannikɛla 15 ɲɛnamaw ɲɛfɔ Ɛsipaɲi, k’u sinsin u ka bolofara fɔlɔw kan, u ka sugu tɔgɔ ɲuman, ani u ka fɛɛrɛ jɔnjɔnw walasa ka biyomedikɛli injiniyɛriw, kolotugudaw operelikɛlaw, ani fɛnw dilanbagaw dɛmɛ u ka se ka latigɛw kɛ minnu bɛ tali kɛ kunnafonidilanw na.

Fɛɛrɛko yiriwali: Ka ɲɛsin wuluw dilanni kɛrɛnkɛrɛnnenw ma minnu bɛ kɛ ni wuluwuluw ye bi joginda sɔrɔli la

Dɔgɔtɔrɔso tender jateminɛ bɛɛ lajɛlen na kɛnɛyaso ɲɛmɔgɔbaw kɔnɔ, kolotugudaw ka joginda sanni bɛ a ɲini ka faamuyali jugu sɔrɔ fɛɛrɛko siratigɛ la, min bɛ kɛ fɛnw doncogo mekanikiniw kan. Nɛgɛ minnu bɛ kɛ wuluwulu kɔnɔ, olu tɛ nɛgɛberew ye minnu bɛ kɛ fɛn bɛɛ ye tuguni; bi opereli bɛ biyomekaniki dilancogo kɛrɛnkɛrɛnnenw de wajibiya minnu bɛ bɛn kari cogoya kɛrɛnkɛrɛnnen ma ani banabagatɔ ka bana cogoya ma.

Walasa ka dɔgɔtɔrɔso ɲɛmɔgɔw ni opereli jɛkuluw dɛmɛ ka joginda sɔrɔcogo nɔgɔya, a nafa ka bon kosɛbɛ ka Intramedullary Nails suguya kɛrɛnkɛrɛnnen fɔlɔw faamuya minnu bɛ bi kolotugudaw ɲɛnajɛyɔrɔw la:

1. Nɛgɛw minnu bɛ ɲɔgɔn siri ɲɔgɔn na (Solid vs. Cannulated) .

Sugandili min bɛ kɛ wuluw dilanni gɛlɛnw ni nɛgɛw dilanni na, o bɛ nɔba bila opereli baara kɛcogo la ani kolo kɛnɛyali biologiki la.

• Nɛgɛ minnu bɛ kɛ ni kankili ye  : O nɛgɛw cɛmancɛ bɛ kɛ ni dingɛ ye, o b’a to u bɛ se ka don ɲɛminɛlan dɔ kan. O kɛcogo in bɛ operelikɛlaw dɛmɛ u ka se ka reamed insertion kɛ, o bɛ medullary canal bonya, ka kɛ sababu ye ka nɛgɛso belebeleba ni barika sɔrɔ, ani ka sigida kolotugudaw yɔrɔw bila ka ɲɛsin kariyɔrɔ ma walasa ka kɛnɛya teliya.

• Nɛgɛso gɛlɛnw : A bɛ kɛ fɔlɔ fɛɛrɛw la minnu ma sɔgɔ, a ka ca a la, wulu gɛlɛnw bɛ sugandi da wulilen jugumanba walima joginda caman na walasa ka tulumafɛnw bɔli farati dɔgɔya ani ka kɔnɔbara joli sɔrɔli dɔgɔya.

2. Senkɔni-nɛgɛw & Senkɔniw kɛrɛfɛ-yɔrɔw

Ni kariw bɛ kɛ senkɔni dakun kɛrɛfɛ (kɔkolo yɔrɔ), wulu minnu bɛ ɲɔgɔn siri cogo la, olu tɛ se ka kɛ. Kungolodimi kɛrɛnkɛrɛnnenw de ka kan ka kɛ walasa ka farikolo doni jugumanw kunbɛn.

• Reconstruction Locking Configurations : Nin dilan ninnu bɛ kɛ ni dingɛ kɛrɛnkɛrɛnnenw ye minnu bɛ tugu ɲɔgɔn kɔ, minnu bɛ kɛ ni degere 130 fo 135 ɲɔgɔn ye, o bɛ kɛ sababu ye ka lag screw gɛlɛnw tɛmɛ nɛgɛ fɛ ka taa senkɔni kun na, ka senkɔniw karilenw siri subtrochanteric walima ipsilateral.

• Anti-Rotation Helical Blade Systems : A bɛ kɛ ka caya mɔgɔkɔrɔbaw ka kɔkolo karilenw na, o fɛɛrɛ ninnu bɛ laadala lag screws bila compression blade nɔ na. Nin dilan in bɛ kolo kansɛri lamini degun sanni k’a bɔ, o bɛ dɔ bɔ kosɛbɛ 'tigɛ' donli la koloci kolo la.

3. Kɔnɔnatumu minnu kolo janw bɛ kɔsegin ni ɲɛfɛla la

Ka kɛɲɛ ni kari yɔrɔ ni farikolo yɔrɔ nɔgɔlenw dafalen ye, operelikɛlaw ka kan ka dondaw sugandi minnu bɛ ɲɔgɔn kɛrɛfɛ walasa ka wulu don.

• Anterograde Sourcing : Fɛn minnu bɛ don a kɔnɔ ka bɔ a kɛrɛfɛla la (misali la, ka don senkɔni na walasa ka senkɔni kari). O bɛ kɛ sababu ye ka wulu biri tigitigi walasa ka bɛn farikolo yɔrɔw kurulenw ma minnu bɛ sɔrɔ u yɛrɛ la.

• Retrograde Sourcing : Fɛn minnu bɛ don a kɔnɔ ka bɔ yɔrɔ jan na (misali la, u bɛ don gɛnɛgɛnɛ kolotuguda sanfɛ dɔrɔn). Senkɔniw kɛrɛnkɛrɛnnen minnu bɛ kɔfɛ, olu bɛ ni yɔrɔjan datugucogo kɛrɛnkɛrɛnnenw ye walasa ka yɔrɔjan kunsigi sabanan karilenw lakana minnu ka gɛlɛn.

Duniya Industry Giants & Leading Brands

1. Stryker ka tɔnba

A ye ɲɛmɔgɔba ye Ɛsipaɲi ka dɔgɔtɔrɔso kɛrɛnkɛrɛnnenw na minnu bɛ se ka kɛ sanfɛyɔrɔ fɔlɔ ye ani inivɛrisite ka bɔnɛko yɔrɔw la minnu ka ca, Ameriki sigida la, Stryker bɛ bonya kosɛbɛ a ka ɛntɛrinɛti injiniyɛri tigitigi n’a ka jago dɛmɛ barikama kosɔn.

• Fɛn fɔlɔ minnu bɛ kɛ: Jogindaw caman cili, robo dɛmɛnanw (Mako), farikoloɲɛnajɛ minɛnw, ani joginda labɛnni fɛɛrɛ kɔrɔw.

• Portfolio koloma : Gamma4 Trochanteric Nail System ani T2 Alpha Interlocking Nail System bɛ masin sabatili ɲɛtaa ni minɛnw labɛncogo laɲinitaw di.

2. DePuy Sintɛsi (Johnson & Johnson MedTech) ka baarakɛminɛnw .

A jɔyɔrɔ min sinsinnen don kosɛbɛ foroba (SNS) dɔgɔtɔrɔsow ni dankan dɔgɔtɔrɔsow bɛɛ la Ɛsipaɲi, DePuy Synthes bɛ baara kɛ ni san tan caman ye kɛnɛyaso ɲininiw na, AO Foundation bɛ minnu dɛmɛ.

• Fɛn fɔlɔ minnu bɛ kɛ : Jogindaw bɛɛ lajɛlen, kolotugudaw labɛnni furaw, ɲɛda ni ɲɛdawolo minɛnw, ani kɔkolo biyomatɛriw.

• Core Portfolio: Expert Nail System ani TFNA (Trochanteric Fixation Nail Advanced) bɛ baara kɛ ni nɛgɛ furakɛli minnu ye u yɛrɛ ta ye, minnu bɛ ɲɛ ka ɲɛsin trochanteric ni kolo janw karilen gɛlɛnw ma.

3. CZMEDITECH ka baarakɛyɔrɔ

I n’a fɔ fangatigi min lakodɔnnen don diɲɛ kɔnɔ kolotugudaw furakɛli minɛnw na, CZMEDITECH ye sɛnɛfɛnw dilancogo sennasan dɔ sigi senkan min bɛ ka bonya Erɔpu Saheliyanfan sugu la, kɛrɛnkɛrɛnnenya la Ɛsipaɲi kɔnɔ. A tɔgɔ bɔra kosɛbɛ ka danfara don Alemaɲi ka fɛn dilanni nafamaba ni fɛn dilanni nafamaba cɛ, o baarakɛda bɛ bɔnɛko caman dilan min bɛ diɲɛ furakɛli yamaruya gɛlɛnw mara — ISO 13485, CE seereyaw sen bɛ o la — o b’a kɛ jɛɲɔgɔn ɲuman ye Hospitales Universitarios belebelebaw ni kɛnɛyaso kɛrɛnkɛrɛnnenw bolo minnu b’a ɲini ka sannifeere kɛ cogo ɲuman na Erɔpu Foroba sannifeere hukumu kɔnɔ cikanw (directives) minnu bɛ di.

• Orthopedic Trauma Systems: Ɲɛnabɔli ɲɛtaa Nɛgɛw kɔnɔna na , Anatomique Locking Plates & Vis, ani Kɛnɛma Fixation Systems (Kɛnɛyako Fixation Systems)..

• Kɔkolo sirili furaw : Kɔnɔbara ɲɛfɛla/kɔfɛla & barajuru, farikolo ni ɲɔgɔn cɛ fusion cages, ani kɔkolo sirili berew.

• Cranio-Maxillofacial (CMF) Implants : Titanium Plates ani Mesh Systems ultra-low profile minnu bɛ ɲɛda labɛn kokura.

• Opereli fanga baarakɛminɛnw ni fɛn wɛrɛw: Orthopedic Drills minnu bɛ baara kɛ kosɛbɛ, Oscillating Saws, ani sterilisation instrument kits minnu bɛ bɛn ɲɔgɔn ma.

• OEM/ODM Services customized : Furakɛcogo min bɛ kɛ laban na ka taa a laban na, o bɛ bɛn diɲɛ dɔgɔtɔrɔsow ka fɛnw ma.

• Core IM Nail Portfolio & Jɛɲɔgɔnyaw:

  • Femoral Intramedullary Nail : A dilannen don ni Titanium Alloy (Ti-6Al-4V ELI) ye min bɛ se ka don a kɔnɔ, a bɛ ni farikolo kurulen ɲuman ye ani a bɛ kɛ ni a datugucogo ye min bɛ kɛ ni planar caman ye walasa ka fixation rigide di shaft fractures complexes ma.

  • Tibial Intramedullary Nail : A dilannen don ni progressive proximal dynamic locking options ye ani profil cannulé, o bɛ girinya ta joona ani kolo kɛnɛyali teliya la.

  • Humeral Intramedullary Nail : Sanfɛla fura kɛrɛnkɛrɛnnen don min bɛ fɛɛrɛ nɔgɔya min tɛ fɛn caman kɛ, ka farikolo yɔrɔ nɔgɔlenw tiɲɛni dɔgɔya ani ka rotator cuff lakana.

  • Proximal Femoral Nail Antirotation - PFNA : A bɛ ni helical blade system ye min ka ɲi banabagatɔ kɔrɔbaw ma minnu kolo jɔcogo bɛ u la, o bɛ a to u ka se ka tigɛcogo ɲuman sabati trochanteric fracture fixation waati.

4. Zimmer Biomet Holdings, Inc. ye baarakɛyɔrɔ ye min bɛ wele ko Zimmer Biomet Holdings.

Zimmer Biomet bɛ kɛnɛyako nizɛri siraw fara ɲɔgɔn kan ni farikolo ni kolotugudaw sirili fɛɛrɛ ɲumanw ye, ka baara kɛ dugubaw kɔnɔ kɛnɛyako sirabaw ye Ɛsipaɲi jamana bɛɛ kɔnɔ.

• Fɛn fɔlɔw: Kɛnɛya jateminɛ nizɛri minnu bɛ bɛn ɲɔgɔn ma, kolotugudaw caman cili, farikoloɲɛnajɛ furakɛli minɛnw, ani joginda doncogo.

• Core Portfolio: Natural Nail System bɛ farikolo yɔrɔw kurulenw jira minnu dabɔra ka bɛn banabagatɔw cogoya suguya caman ma Erɔpu siya caman ka jamanaden hakɛw kɔnɔ.

5. Smith & Nephew ka baarakɛyɔrɔ

Ni baara tilennenw bɛ baara la ani ni fɛnw ladonni yɔrɔ barikamaw ye Erɔpu Tlebi fan bɛɛ la, Angletɛri sigida Smith & Nephew ka fisa ni joginda ladonni ɲɛtaa ye ani joginda kɛrɛnkɛrɛnnenw na.

• Fɛn fɔlɔ minnu bɛ kɛ: Jogindaw furakɛcogo kɔrɔlenw, joli-sira-funu-yɔrɔ-ko-minɛnw, ani kolotugudaw ka joginda-minɛnw.

• Core Portfolio: TRIGEN Interlocking Nail System bɛ ni yɔrɔ kɛrɛnkɛrɛnnenw ye minnu bɛ kɛ ka ɲɛ walasa ka senkɔniw ni senkɔniw karilen jugumanw kunbɛn.

6. B. Braun Melsungen A. G. (Asculap) ye baara kɛ ni a ye.

A bɛ Alemaɲi injiniyɛri kuncɛyɔrɔ jira ni tariku ni tɔnba ye Ɛsipaɲi (a sigiyɔrɔba bɛ Rubí, Barselona), B. Braun bɛ Ɛsipaɲi dɔgɔtɔrɔsow dɛmɛ ni bɔnɛko cogoyaw ye minnu bɛ mɛn cogo kɛrɛnkɛrɛnnen na, minnu dilannen don ni tigitigi ye.

• Fɛn fɔlɔ minnu bɛ kɛ: Pikirijikɛlanw, opereli minɛnw, kɔkolo doncogo, ani structural trauma hardware.

• Core Portfolio: Targon Interlocking Nail System bɛ da tugucogo ɲumanba di walasa ka kolo janw senkɔni ni senkɔniw jɔcogo kura ɲini.

7. Medtronic ka baarakɛyɔrɔ

Hali n’a fanga ka bon kosɛbɛ pacemakers ni kɔkolo minɛnw na, Medtronic ka structural osteo-division bɛ baara kɛ ni fɛn gɛlɛnw ye minnu bɛ se ka kɛ sababu ye ka joginda caman jɔli wajibiyalenw kɛ marabolow kɔnɔ Ɛsipaɲi kɛnɛyajɛkuluw kɔnɔ.

• Fɛn fɔlɔ minnu bɛ kɛ: Kɔkolo fɛnɲɛnamafagalanw, taamayɔrɔ kɔrɔlenw, hakiliɲagami opereli minɛnw, ani joginda kɛrɛnkɛrɛnnenw doncogo.

• Core Portfolio : Minɛnw dilanni minnu bɛ se ka wuli ka bɔ ɲɔgɔn na, olu ni diɲɛ bɛɛ ka ɲɔgɔn cɛ cogoyaw faralen don ɲɔgɔn kan minnu bɛnnen don kolotugudaw jɔli ma ni gɛlɛyaba ye.

8. Orthofix Medical Inc. ka baarakɛyɔrɔ.

Orthofix ka fisa ni kɔnɔna ni kɛnɛma fixation philosophies faralen ye ɲɔgɔn kan, a bɛ biologique remodeling sugandili kɛrɛnkɛrɛnnenw di kolotugudaw kɛrɛnkɛrɛnnenw ma Ɛsipaɲi jamana bɛɛ kɔnɔ.

• Fɛn fɔlɔw: Kɛnɛma fɛnɲɛnamafagalanw, kolo falenni furakɛli fɛɛrɛw, ani senkɔniw janya lajɛ kɛrɛnkɛrɛnnenw.

• Core Portfolio : Denmisɛnw ni balikuw ka mikro-nailing systems kɛrɛnkɛrɛnnenw minnu sinsinnen bɛ intertrochanteric walima shaft kolo gɛlɛya jugumanw ɲɛnabɔli kan.

9. Acumed LLC ka baarakɛyɔrɔ

Acumed bɛ sinsin farikolo yɔrɔw tiɲɛni kan sanfɛla karilenw na, ka minɛn kɛrɛnkɛrɛnnenw di minnu ka di kamankun ni sanfɛbolo kɛrɛnkɛrɛnnenw ye Ɛsipaɲi dɔgɔtɔrɔso kɛrɛnkɛrɛnnenw na.

• Fɛn fɔlɔ minnu bɛ kɛ: Farikolo yɔrɔw datugulanw, koloci kɛrɛnkɛrɛnnenw, ani sanfɛla-kɔnɔna-kɔnɔ-berew laɲinitaw.

• Core Portfolio : Nɛgɛw ni bolokɔniw kɔnɔbara minnu bɛ duguma, olu dabɔra ka farikolo yɔrɔ nɔgɔlenw sɔgɔli nɔgɔya.

10. Globus Medical, Inc. ka baarakɛyɔrɔ.

A ka jɛkafɔba kɔfɛ ni NuVasive ye, Globus Medical y’a ka bɔnɛ ni jɔli senna teliya la bonya kɛnɛyako kɛrɛnkɛrɛnnenw ka rezow kɔnɔ Erɔpu Saheliyanfan na.

• Fɛn fɔlɔw: Farikolo ni kolotugudaw furakɛcogo bɛɛ lajɛlen, kɔkolo fɛnɲɛnamafagalan kɔrɔlenw, ani robo dɛmɛni ka joginda ɲɛminɛcogo.

• Portfolio koloma : CAPTIVATE Trauma System, min bɛ ni minɛnw ye minnu bɛ se ka kɛ ka ɲɛ, minnu dabɔra senkɔni ni senkɔniw ka ɲɔgɔn cɛ ka ɲɛ.

11. Wright Dɔgɔtɔrɔso kulu NV (A Stryker Company) .

Baara kɛli Stryker ka joginda denbaya kɔnɔ, Wright Medical ka senkɔniw ni senkɔniw fɛnɲɛnamafagalan kɔrɔw tora sugandili sanfɛla ye kolotugudaw jɔli ni u farali gɛlɛnw na Ɛsipaɲi.

• Fɛn fɔlɔ minnu bɛ kɛ: Sanfɛla senkɔniw doncogo, senkɔniw bɛɛ cili, ani kolotugudaw sɔgɔcogo kɔrɔlenw.

• Core Portfolio: Senkɔniw ni senkɔniw fusili bere kɛrɛnkɛrɛnnenw minnu bɛ segin kɔfɛ, minnu dilannen don joli-sira-funu opereli gɛlɛnw kama.

12. Aap ka AG don a kɔnɔ

Aap Implantate ye Alimanjamana ka fɛn dilannikɛla ye min lakodɔnnen don a ka warijɛ dacogo kura ni banakisɛfagalanw dabɔli fɛɛrɛ kuraw labɛnni na minnu dabɔra walasa ka banakisɛw dɔgɔya minnu bɛ sɔrɔ fɛnw doncogo fɛ.

• Fɛn fɔlɔ minnu bɛ kɛ: LOQTEQ locking plate family ani warijɛ bɛ kɛ ni banakisɛfagalanw ka joginda ye.

• Core Portfolio : Titanium interlocking systems cannulées et solides jɔlen don walasa ka opereli kɔfɛ gɛlɛyaw dɔgɔya kolo janw kɛtuma na.

13. CarboFix Orthopedics Ltd. ka baarakɛyɔrɔ.

CarboFix ye ɲɛmɔgɔ ye karɔbɔli-fibre fɛɛrɛbɔ la, a bɛ nafa jiracogo kɛrɛnkɛrɛnnenba di kansɛri furakɛli ma min bɛ tali kɛ kolotugudaw opereli la Ɛsipaɲi kansɛri furakɛli yɔrɔ kɛrɛnkɛrɛnnenw bɛɛ kɔnɔ.

• Fɛn fɔlɔ minnu bɛ kɛ: Polimɛri platiw minnu barika ka bon ni fibre carbone ye, kabon nails structurels, ani trauma implants radiolucentes.

• Core Portfolio : Piccolo Composite Nails, o bɛ sira di ja jɛlenw ma, minnu tɛ fɛn dilannenw ye, kansɛribana tuguni ni fiɲɛ furakɛli laɲiniw senfɛ.

14. MicroPort dɔnniya tɔnba

MicroPort bɛ baara kɛ ni izini fɛnsɔrɔsiraw ye minnu ka bon, a bɛ dusukun ni jolisiraw ni kolotugudaw sugandicogo caman tilatila Erɔpu Saheliyanfan siraw kan, minnu musaka ka dɔgɔ, minnu hakɛ ka ca, walasa ka dɔgɔtɔrɔsow ka baarakɛnafolo dantigɛli gɛlɛnw dafa.

• Fura fɔlɔw: Dusukun ni jolisiraw ka stent minnu tɛ fɛn caman kɛ, kolotugudaw, ani joginda labɛnni minɛn dafalenw.

• Core Portfolio : Nail systems intramedullaires interlocking minnu dilannen don walasa ka segin-ka-bɔnye fɛɛrɛw kɛ, minnu bɛ se ka kɛ ka ɲɛ.

15. Wego Ortho (Weigao kulu) .

Wego Ortho ye Azi furakɛlitɔnba dɔ ye, a bɛ furakɛli suguya dɔw lase mɔgɔ ma minnu bɛ se ka da u kan kosɛbɛ, minnu bɛ Erɔpu dɔgɔtɔrɔsow ka ɲinini gɛlɛnw dafa.

• Fɛn fɔlɔ minnu bɛ kɛ: Kɔkolo sirili minɛnw, structural trauma plates, kolotugudaw, ani opereli fɛnw sterili.

• Core Portfolio : Titaniyɔmu nɛgɛso minnu bɛ ɲɔgɔn cɛ minnu bɛ mɛn, minnu dilannen don foroba marabolow ka tenderiw kama minnu musaka ka dɔgɔ Ɛsipaɲi.

── FƐN SƆRƆLI MATRIX ──

Ɲininkali minnu bɛ kɛ tuma caman na (FAQ) .

J1: Yala wuluwulu minnu ka kan ka kɛ Ɛsipaɲi sugu la, olu mago bɛ CE Marking la EU MDR kɔnɔ wa?

Ɔwɔ, tiɲɛ yɛrɛ la. Erɔpu furakɛli minɛnw sariyasun (MDR 2017/745) waleyali dafalen kɔfɛ, wuluwuluw bɛɛ minnu bɛ feere Ɛsipaɲi, olu ka kan ka kɛ ni taamasiyɛn ye min bɛ se ka kɛ MDR ka laadilikanw kɔnɔ CE Klasi IIb ni kalasi III kolotugudaw bɛ kɛnɛyaso jateminɛ gɛlɛnw sɔrɔ, ka fɛɛrɛw lajɛ minnu bɛ kɛ ni fɛɛrɛ ye, ani ka kɛnɛyaso tugu-tugu ɲɔgɔn kɔ (PMCF). Sannifeere ɲɛmɔgɔw ka kan k’a lajɛ ko diɲɛ kɔnɔ fɛn dilannikɛla o fɛn dilannikɛla, i n’a fɔ CZMEDITECH, o bɛ bɛnkansɛbɛn di, wa a tɔgɔ sɛbɛnna ka dafa EUDAMED ka kunnafonidilan kɔnɔ.

J2: I tɔgɔ sɛbɛnni wajibiyalen kɛrɛnkɛrɛnnen jumɛnw bɛ Ɛsipaɲi AEMPS la?

Hali ni CE Mark bɛ baara la, furakɛli minɛn o minɛn bɛ tila Ɛsipaɲi kɔnɔ, o ka kan ka ladɔnniya AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) la Aplicación de Comunicación de Comercialización de Productos Sanitarios (CCPS) fɛ. Fɛn minnu bɛ don jamana kɔnɔ ani sigida la, olu fana ka kan ka Licencia Previa de Funcionamiento de Instalaciones (Baarakɛyɔrɔw ka lase fɔlɔ) sɔrɔ, o min b’a to jamana kɔnɔ kɔlɔsili dafalen bɛ kɛ sanni fɛnw ka se ka sɔngɔ ɲini sariya siratigɛ la marabolow ka licitasiyɔnw kɔnɔ.

J3: Mun na Helical Blade sitɛmuw (i n’a fɔ PFNA) bɛ bila jɔyɔrɔ fɔlɔ la kosɛbɛ marabolow ka kɛnɛyako baaradaw la (misali la, SERMAS, SAS)?

Ɛsipaɲi ye jamana ye min ka ɲɛnamaya hakɛ ka ca ani jamanaden hakɛ kɔrɔlenba dɔ ye Erɔpu jamanaw na, o bɛ na ni doni belebeleba ye kolotugudaw karilenw na. Laadalata lag screws ka teli ka dɛsɛ ka tɛmɛn masin 'cut-out' fɛ kolo barikama na. Ka sigida kɔrɔw sɔrɔ i n’a fɔ CZMEDITECH ka PFNA, n’o bɛ baara kɛ ni fɛnɲɛnamafagalan ye min bɛ se ka kolotugudaw digidigi sanni ka kolotugudaw sɔgɔ, o bɛ dɔ fara jiginni sabatili kan ani ka dɔgɔtɔrɔso ladonni ni seginnkanni musakabaw bali kosɛbɛ — o ye jatebɔ sariyakolo jɔnjɔnw ye foroba san caman feereli bɛnkansɛbɛnw kɔnɔ.

J4: Ɛsipaɲi forobaciyɛnko sariya (LCSP) bɛ nɔ jumɛn bila IM nɛgɛw sɔrɔyɔrɔ la?

Ɛsipaɲi ka forobacakɛda ka bɛnkansɛbɛnw sariya kɔnɔ ( Ley de Contratos del Sector Público - LCSP ), foroba dɔgɔtɔrɔso sanni tɛ se ka da sɔngɔ dɔrɔn kan. Licitasiyɔnw labɛnna Value-Based Procurement lamini na , yɔrɔ min na fɛɛrɛko nafaw (fɛnw labatoli i n’a fɔ Titanium ASTM F136 san 5nan, minɛnw ergonomi, traceability, ani clinical data) bɛ se ka se 50–60% ma jate bɛɛ lajɛlen na. Dilanbaga minnu bɛ masinko ɲɛfɔli ɲumanw di ni logistiki baarakɛcogo ɲuman ye (i n’a fɔ CZMEDITECH), olu bɛ se ka ɲɔgɔn sɔrɔ kosɛbɛ.

J5: Traceability controls jumɛnw ka kan ka kɛ wuluw la minnu bɛ kɛ wuluw kɔnɔ Ɛsipaɲi dɔgɔtɔrɔsow kɔnɔ?

Ɛsipaɲi bɛ UDI (Unique Device Identification) siratigɛ labato kosɛbɛ EU ka cikanw kɔnɔ. Nɛgɛ kelen kelen bɛɛ ni sɔgɔsɔgɔninjɛ min bɛ ɲɔgɔn cɛ, o ka kan ka kɛ ni barɔdi nɔfɛtaamacogo ye (DataMatrix) min bɛ se ka tugu dafalen di ka bɔ a dilabaga fɛ ka taa a bila banabagatɔ kɛrɛnkɛrɛnnen ka kɛnɛyako sɛbɛn ɛntɛrinɛti kan (EHR). Sigida jatebɔlaw ka kan ka lot/batch tracking systems dafabaliw mara walasa ka hakilijigin teliya walima lakana lasɔminiw kɛ ni AEMPS ye darapo jira.

J6: Yala Ɛsipaɲi kɛnɛyako kuluw bɛ se ka bɔnɛ sira caman fara ɲɔgɔn kan ka bɔ diɲɛ fɛn dilannikɛla kelen na wa?

Ɔwɔ, wa o bɛ dusu don kosɛbɛ musaka ni marako ɲɛnabɔli la. Ka bɔnɛ siraw sabati jɛɲɔgɔn tilennen kelen fɛ walima sɔrɔyɔrɔ kelen tilabaga yamaruyalen fɛ, o bɛ kɛ sababu ye Ɛsipaɲi dɔgɔtɔrɔso kuluw (i n’a fɔ HM Hospitales walima Quirónsalud) walima marabolo sannikɛyɔrɔw ka nafa sɔrɔ sɔrɔko siratigɛ la. Ka bɔ fɛn dilannikɛla jɛlen dɔ la i n’a fɔ CZMEDITECH, o b’a to dɔgɔtɔrɔso jɛkulu dɔ ka se ka Senkɔniw, Senkɔniw, farikolo yɔrɔw datugulanw, ani furakɛli kuran baarakɛminɛnw sɔrɔ waati kelen na—ka marako faturaw ɲɛnabɔli nɔgɔya, ka dɔ bɔ doni tali sennafɛnw na minnu bɛ tali kɛ doni tali la, ani ka opereli minɛnw labɛncogo bɛnnenw sabati opereli so rezow bɛɛ kɔnɔ.

Kuncɛli

K’a sɔrɔ Ameriki Woroduguyanfan ni Cɛma Erɔpu jamanaw ka laadala ciyɛn taamasiyɛnw bɛ ka taa a fɛ ka tariku suguya caman sɔrɔ Ɛsipaɲi ka santiri fɔlɔw la, wariko ɲinini minnu bɛ ka bonya Sistema Nacional de Salud (SNS) kan, olu ye wuli ka taa fɛn dilannikɛlaw fɛ minnu bɛ teliya, minnu ka seereyaw bɛ diɲɛ kɔnɔ. Baarakɛlaw i n’a fɔ CZMEDITECH, olu bɛ nafa jiracogo dɔ di min bɛ mɔgɔ bila ka miiri kosɛbɛ Ɛsipaɲi ka bi bɔnɛko yɔrɔw la, u kɛtɔ ka Erɔpu furakɛli seereyaw (CE MDR) ɲumanw ni fɛnɲɛnamafagalanw bɛn ɲɔgɔn ma minnu bɛ se ka don fɛnw na ni fɛn dilanni jɔcogo ɲumanw ye.

Kuncɛli

K’a sɔrɔ Ameriki Woroduguyanfan laadala aCentral Erɔpu jamanaw ka ciyɛn taamasiyɛnw bɛ ka taa a fɛ ka tariku suguya caman sɔrɔ Ɛsipaɲi ka santiri fɔlɔw la, wariko ɲinini minnu bɛ ka bonya Sistema Nacional de Salud (SNS) kan, olu ye wuli ka taa fɛn dilannikɛlaw fɛ minnu bɛ teliya, minnu ka seereyaw bɛ diɲɛ kɔnɔ. Furakɛlaw bɛ i n’a fɔ CZMEDITECH bɛ nafa jiracogo dɔ di min bɛ mɔgɔ bila ka wale kɛ kosɛbɛ Ɛsipaɲi ka bi bɔnɛko yɔrɔw la, a kɛtɔ ka Erɔpu furakɛli seereyaw ɲumanw (CE /ISO) ni fɛnɲɛnamafagalanw bɛn ɲɔgɔn ma minnu bɛ se ka don fɛnw na ni fɛn dilanni jɔcogo ɲumanw ye.