Bulgari jamana na, wuluw dilannikɛla 15 minnu bɛ ɲɛgɛnɛsira kɔnɔ (2026 sannifeere gafe)

Daminɛ kuma

Furakɛminɛnw sanniko siratigɛ la Bulgari jamana kolotugudaw la, o bɛ ka wuli teliya la u jɔcogo la. A bɛ ɲɛminɛ ni sigida ka baarakɛcogo ɲuman yamaruyaw ye ka bɔ kɛnɛya minisiriso la ( Министерство на здравеопазването ) ani bɔnɛ hakɛ caman minnu bɛ ɲɛnabɔ inivɛrisite rezobaw fɛ ani dɔgɔtɔrɔso kɛrɛnkɛrɛnnenw fɛ Fasokanw ka kɛnɛyako lasigidenso ( НЗОК ) kɔnɔ—i n’a fɔ Pirogov Emergency Hospital (Sofia), MHAT 'St. Anna' (Sofia), Iniwɛrisite dɔgɔtɔrɔso 'St. George' (Plovdiv), ani Dusukun ni hakilijagabɔso minnu ka gɛlɛn kosɛbɛ (Burgas ani Pleven), ka fara dɔgɔtɔrɔso kɛrɛnkɛrɛnnen kuluw kan minnu ka bon kosɛbɛ i n’a fɔ Acibadem City Clinic ani Vita—dɔgɔtɔrɔso sannitɔnw 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 ɲɛgɛnɛsira kɔnɔ (IM) jɛɲɔgɔn ɲuman sugandi, o nafa ka bon kosɛbɛ walasa ka opereli kɔfɛ gɛlɛyaw dɔgɔya ani ka sigida musakaw ɲɛnabɔ Bulgari jamana ka foroba sannifeere sariya kɔnɔ ( Закон за обществените поръчки - ЗОП ). Nin gafe in bɛ Bulgari jamana na, wuluw dilannikɛla 15 minnu bɛ ɲɛgɛnw kɔnɔ, olu ɲɛfɔ, k’u sinsin u ka baarakɛminɛn 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 sinsinnen bɛ kunnafoniw kan.

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

Bulgari jamana ka inivɛrisite tier-1 rezow la ani bɔnɛko yɔrɔ kɛrɛnkɛrɛnnenw na, 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 dɔgɔtɔrɔsow ni dankan dɔgɔtɔrɔsow bɛɛ la Bulgari jamana na, DePuy Synthes bɛ baara kɛ ni san tan caman ye kɛnɛyaso ɲininiw na minnu bɛ dɛmɛn AO Foundation fɛ.

• 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 sɔrɔli sennasanbara dɔ sigi senkan min bɛ ka bonya Erɔpu kɔrɔnyanfan sugu la, kɛrɛnkɛrɛnnenya la Bulgari jamana kɔnɔ. A tɔgɔ bɔra kosɛbɛ ka danfara don Alemaɲi ka fɛn dilanni nafamaba ni fɛn dilanni nafama cɛ, min bɛ se ka ɲɔgɔn sɔrɔ kosɛbɛ, 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 foroba dɔgɔtɔrɔsobaw ni kɛnɛyaso kɛrɛnkɛrɛnnenw bolo minnu b’a ɲini ka sannifeere caman kɛ ka ɲɛ UE kɔnɔ Sannifeere cikanw.

• 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 Bulgari 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 jamanaden hakɛ bɛɛ la.

5. Smith & Nephew ka baarakɛyɔrɔ

Ni baara tilennenw bɛ baara la ani ni fɛnw ladonni yɔrɔ barikamaw ye Erɔpu jamanaw 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 sanfɛla jira, B. Braun bɛ tɔnba ni tilali fɛnsɔrɔsiraw mara minnu bɛ se ka da a kan kosɛbɛ Erɔpu Saheliyanfan bɛɛ la, ka Bulgari dɔgɔtɔrɔsow dɛmɛ ni bɔnɛko cogoyaw ye minnu bɛ mɛn cogo kɛrɛnkɛrɛnnen na, minnu dilannen don cogo tigitigi la.

• 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 bɔgɔbɔgɔ caman sirili wajibiyalenw kɛ Bulgari jamana ka kɛnɛyako kuluw 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 Bulgari 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 fɛɛrɛ kɛrɛnkɛrɛnnenw di minnu ka di sanfɛ-bolo-kɛrɛnkɛrɛnnenw ye Bulgari jamana ka dɔgɔtɔrɔsobaw la.

• 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 dɔgɔtɔrɔsow ka rezow kɔnɔ Erɔpu cɛmancɛ ni kɔrɔnyanfan fɛ.

• 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 fusili gɛlɛnw ni u latilenni kama Bulgari jamana na.

• 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 karɔbɔni-fibre fɛɛrɛbɔ la, a bɛ nafa jiracogo kɛrɛnkɛrɛnnenba di kansɛri furakɛli ma min bɛ tali kɛ kolotugudaw opereli la Bulgari jamana kansɛri 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 kɔrɔnyanfan 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 jamana ka tenderi bɛnkansɛbɛnw kama minnu musaka ka dɔgɔ ani tenderi caman bɛnkanw kama Bulgari jamana na.

── FƐN SƆRƆLI MATRIX ──

Ɲininkali minnu bɛ kɛ tuma caman na (FAQ) .

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

Ɔwɔ, tiɲɛ yɛrɛ la. Ikomi Bulgari ye Erɔpu tɔnba kɔnɔmɔgɔ dafalen ye, wuluwulu minnu bɛ jago kɛ jamana kɔnɔ, olu bɛɛ ka kan ka kɛ ni CE taamasiyɛn ye min bɛ se ka kɛ furakɛli minɛnw sariyasen (MDR 2017/745) kɔnɔ Klasi IIb ni kalasi III kolotugudaw bɛ sɛgɛsɛgɛli gɛlɛnw kɛ fɛɛrɛko siratigɛ la ani ka kɛnɛyaso jateminɛ. Sannifeere ɲɛmɔgɔw ka kan k’a sɛgɛsɛgɛ ko jamana wɛrɛw ka fɛn dilannikɛla o fɛn dilannikɛla, i n’a fɔ CZMEDITECH, o bɛ bɛnkansɛbɛn dɔ di min bɛ baara kɛ, wa a tɔgɔ sɛbɛnnen bɛ cogo bɛnnen na EUDAMED ka kunnafonidilan kɔnɔ.

J2: I tɔgɔ sɛbɛnni wajibiyalenw ye mun ye Bulgari furako baarada (BDA) la?

Bulgari jamana ka sariya min bɛ furakɛli minɛnw kan ( Закон за медицинските изделия ), minɛn minnu bɛ ni CE taamasiyɛn ye min bɛ se ka kɛ kaban ka bɔ EU ladɔnniya jɛkulu dɔ fɛ, olu mago tɛ sɛbɛnni danfaralen na, min yɛrɛmahɔrɔnyalen don BDA fɛ (Bulgarie furako baarada / Изпълнителна агенция по ИАЛ) . Nka, ni a dilabaga sigilen bɛ Erɔpu sɔrɔko yɔrɔ (EEA) kɔkan, u ka kan ka lasigiden yamaruyalen (AR) sigi UE kɔnɔ. Bulgari jamana ka sigida feerela fana ka kan k’u ka jago baara sɛbɛn ani ka fɛɛrɛ sɛbɛnw mara sigida la san duuru ni kɔ la ni BDA ka sɛgɛsɛgɛli kɛra.

J3: Mun na Helical Blade sitɛmuw (i n’a fɔ PFNA) ye fɔlɔ ye NHOK ka baarakɛnafolo tilali la Bulgari jamana na?

Bulgari jamana bɛ gɛlɛya kɛrɛnkɛrɛnnenw sɔrɔ jamanaden hakɛ la ni jamanaden kɔrɔbayalenw ye, o bɛ kɛ sababu ye ka mɔgɔkɔrɔbaw ka kɔkili kari hakɛ caman sɔrɔ. Laadalata lag screws bɛ dɛsɛ hakɛ caman sɔrɔ masin 'cut-out' fɛ koloci kolo la. Furakɛcogo kɔrɔw sɔrɔli i n’a fɔ CZMEDITECH ka PFNA — yɔrɔ min na helical blade bɛ lamini kolo degun sanni k’a sɔgɔ ka bɔ — o bɛ jiginni sabatili caya. O bɛ dɔ bɔ opereli kɔfɛ seginnkanni musakabaw la ani banabagatɔw ka gɛlɛyaw, o min nafa ka bon kosɛbɛ jamana ka kɛnɛyako lasigidenso ( НЗОК ) ka wariko dantigɛli gɛlɛnw kɔnɔ.

J4: Bulgari jamana ka foroba sannifeere sariya (ZOP) bɛ nɔ jumɛn bila IM nɛgɛw sɔngɔko la?

kɔnɔ ЗОП (Закон за обществените поръчки) , foroba dɔgɔtɔrɔsow ka rezow bɛ san caman feereli baarakɛɲɔgɔnya di ka da 'sɔrɔko nafa ka bon kosɛbɛ.' Nin fɛɛrɛ in bɛ Nafa-Sanni sariyaw fara ɲɔgɔn kan kosɛbɛ, ka jatebɔ girinyaba di fɛɛrɛko labatoli ma (i n’a fɔ Grade 5 Titanium Alloy Ti-6Al-4V ELI material certification, anatomical bows tigitigiw, ani instrument kit ergonomics) ka fara sɔngɔ kan. Dilanbaga minnu bɛ sɛnɛfɛnw dilanni sigicogo ni sariyaw lakanani di minnu bɛ se ka ɲɔgɔn sɔrɔ kosɛbɛ (i n’a fɔ CZMEDITECH), olu jɔyɔrɔ ka ɲi kosɛbɛ walasa ka se sɔrɔ nin forobaciyɛnko siratigɛ la.

J5: Fura kunnafoniw ka kan ka di kan jumɛnw na Bulgari dɔgɔtɔrɔsow la?

Ka kɛɲɛ ni BDA ka sariyaw ye, banabagatɔ ɲɛda kunnafoniw, sɛbɛnw, ani baarakɛcogo ɲɛfɔli sɛbɛnw (IFU) bɛɛ ka kan ka di Bulgarikan na . Hali ni opereli fɛɛrɛbɔcogo ɲɛjiralanw bɛ sɔn tuma caman na tubabukan na kolotugudaw la, tenderi tɔnw bɛ sigida kan bamanankan baarakɛcogo labato kosɛbɛ walasa ka sariyaw sigicogo ni sterilize sariyaw mara walasa ka sigida lakanani sariyaw mara.

J6: Yala Bulgari dɔgɔtɔrɔso kuluw bɛ se ka nafa sɔrɔ u ka bɔnɛ sanni siraw sabatili la wa?

Ɔwɔ, jɛ-ka-baara ye fɛɛrɛ ye min bɛ se ka kɛ kosɛbɛ walasa ka sigida musakaw kunbɛn. Ni joginda sanni kɛcogo kɛra sariya ye ni fɛn dilanni jɛɲɔgɔn kelen ye i n’a fɔ CZMEDITECH, dɔgɔtɔrɔso jɛkuluw walima mara kɛnɛyasobaw bɛ se ka kumaɲɔgɔnya kɛ sanni caman kɛli sariyaw kan. O b’a to u bɛ se ka Senkɔniw, Senkɔniw, farikolo yɔrɔw datugulanw, ani furakɛli fanga baarakɛminɛnw siri ɲɔgɔn na. O fɛɛrɛ in bɛ dɔ bɔ kurunbokari ni dumuniko ɲɛnabɔli bɛɛ lajɛlen na, ka fɛnmarayɔrɔw nɔfɛta musakaw dɔgɔya, ka minɛnw sigicogo sariyalen sigi senkan sinemasow ka rezow bɛɛ kɔnɔ.

Kuncɛli

Hali ni Erɔpu Tlebi ni Ameriki Woroduguyanfan laadala ciyɛn taamasiyɛnw bɛ ka taa a fɛ ka sennateliya kɛrɛnkɛrɛnnen mara Bulgari jamana ka dɔgɔtɔrɔso kɛrɛnkɛrɛnnenw na, nafolo gɛlɛya minnu bɛ foroba kɛnɛyako baarakɛnafolo kɔnɔ ( НЗОК ) ani forobaciyɛnko ( ЗОП ) ka ɲɔgɔndan kɛcogo ye wuliba bila 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 miiri kosɛbɛ Bulgari ka bi bɔnɛko yɔrɔw la, a kɛtɔ ka Erɔpu furakɛli seereyaw (CE/ISO) ɲumanw ni fɛnɲɛnamafagalanw ni fɛn dilanni jɔcogo ɲumanw bɛn ɲɔgɔn ma.