Abakhiqizi abangu-15 abaphambili Isipikili sangaphakathi komongo wethambo e-Spain (2026 Procurement Guide)

Isingeniso

Indawo yokuthengwa kwemishini yezokwelapha emkhakheni wamathambo wase-Spain ihlangabezana nokuvela kwesakhiwo esisheshayo. Iqhutshwa iziyalezo eziqinile zokuqukatha izindleko ezivela ku-Ministry of Health ( Ministerio de Sanidad ) kanye nenani eliphansi lokuhlukumezeka eliphezulu elilawulwa yizinsizakalo zezempilo zomphakathi ezizimele ( Servicios de Salud Autonómicos )—njenge-SERMAS (Madrid), SAS (Andalucía), Catsalut (Cataluña), kanye ne-SACYL Leónsti ehola isibhedlela esizimele, kanye ne-SACYL Leónsti (isibhedlela esizimele) kanye namabhodi okuthengwa kwempahla esibhedlela i-Vithas abeka kuqala izimila ezinikeza ibhalansi efanele yokusebenza komtholampilo, ukuvikeleka kokulawula, kanye nokubikezelwa kwesabelomali.

Lapho ulawula ukuphuka kwamathambo amade, ukukhetha uzakwethu olungile wezinzipho we-intramedullary (IM) kubalulekile ekwehliseni izinkinga zangemva kokuhlinzwa kanye nokuphatha izindleko zesikhungo ngaphansi kohlaka lwe -Licitaciones Públicas (Amathenda Omphakathi). Lo mhlahlandlela uphrofayili Abakhiqizi Abaphezulu abangu-15 Isipikili sangaphakathi komongo wethambo e-Spain, egxile kumaphothifoliyo abo ayinhloko, isithunzi semakethe, nobuchwepheshe obuyinhloko ukuze basize onjiniyela be-biomedical, odokotela abahlinzayo bamathambo, kanye nabaphathi be-supply chain ekwenzeni izinqumo eziqhutshwa idatha.

Ukunwetshwa Kobuchwepheshe: Ukuqonda Imiklamo Ekhethekile Isipikili sangaphakathi komongo wethambo Ekutholeni Ukuhlukumezeka Kwesimanje

Ekuhlolweni kwethenda yezokwelapha okuphelele kuzo zonke izindawo zokunakekelwa kwezempilo ezihamba phambili, ukuthengwa kwe-orthopedic trauma kudinga ukuqonda okujulile kobuchwepheshe bemishini yokufakelwa. Izinzipho ze-Intramedullary azisezona izinduku zensimbi ezijwayelekile; ukuhlinzwa kwesimanje kudinga imiklamo ekhethekile kakhulu ye-biomechanical ehambisana nokucushwa kokuqhekeka okuqondile kanye nesifo sesiguli.

Ukusiza amabhodi ezibhedlela namakomiti okuhlinza enze lula ukuthola ukuhlukumezeka, kubalulekile ukuqonda izigaba ezikhethekile ze Izipikili zangaphakathi komongo wethambo eziphethe amatiyetha esimanje amathambo:

1. I-Interlocking Izipikili zangaphakathi komongo wethambo (I-Solid vs. Cannulated)

Ukukhetha phakathi kwemiklamo eqinile nezinzipho ekheniwe kuba nomthelela omkhulu ekusebenzeni kokuhlinzwa kanye nokuphulukiswa kwamathambo ebhayoloji.

• I-Cannulated Izipikili zangaphakathi komongo wethambo  : Lezi zinzipho zinendawo engenalutho, ezivumela ukuthi zifakwe phezu kwentambo yomhlahlandlela. Lo mklamo uvumela odokotela abahlinzayo ukuthi bafake i-remed, enweba umsele we-medullary, kuvumela isipikili esikhulu, esiqinile, futhi sibeke izingcezu zamathambo zendawo ngqo endaweni yokuphuka ukuze kusheshiswe ukuphulukiswa.

• Okuqinile Izipikili zangaphakathi komongo wethambo : Ngokuyinhloko ezisetshenziswa kumasu angareywanga, izinzipho eziqinile zivame ukukhethwa ekwephuleni okukhulu okuvulekile noma izimo ze-polytrauma ukuze kwehliswe ingcuphe ye-fat embolism kanye nokunciphisa ukuphazamiseka kokunikezwa kwegazi endosteal.

2. I-Cephalomedullary Nails & Proximal Femoral Systems

Ngokuphuka okwenzeka ekugcineni okuseduze kwe-femur (isifunda se-hip), izipikili ezijwayelekile ezihlanganisiwe azanele. Amasistimu e-cephalomedullary akhethekile ayadingeka ukuze kusingathwe imithwalo yemvelo eyeqile.

• Ukulungiselelwa Kokukhiya Kabusha : Le miklamo ifaka izimbobo ezikhethekile zokulandela umkhondo ezisondele cishe kumadigri angu-130 kuya kwangu-135, okuvumela izikulufu ezisindayo ukuthi zidlule kuzipho ziqonde ngqo ekhanda lesifazane, zivikele ukuphuka kweshaft ye-femal subtrochanteric noma ipsilateral.

• I-Anti-Rotation Helical Blade Systems : Isetshenziswa kakhulu lapho kuqhekeka inqulu ye-geriatric, lawa masistimu athatha indawo yezikulufu ze-lag ezivamile nge-compression blade. Lo mklamo ucindezela ithambo elikhansela elizungezile kunokuba ulisuse, wehlisa kakhulu ingcuphe 'yokusika' ethanjeni le-osteoporotic.

3. I-Retrograde vs. Anterograde Long-Bone Nails

Ngokuya ngendawo yokuphuka kanye nobuqotho bezicubu ezithambile, odokotela abahlinzayo kufanele bakhethe izingosi zokungena eziphambene zokufakwa kwezinzipho.

• I-Anterograde Sourcing : Izimila ezifakwe kusukela ekugcineni kwe-proximal (isb, ukungena ku-trochanter ngokuphuka kwe-femur). Lokhu kudinga ukugoba kwezinzipho okunembe ukuze kufane nokugoba kwemvelo kwe-anatomical.

• I-Retrograde Sourcing : Izimila ezifakwe kusukela ekugcineni kwe-distal (isb, ukungena ngenhla nje kwelunga ledolo). Izinzipho ezikhethekile ze-retrograde femoral zifaka amaphethini okukhiya ahlukile ukuze kuvikeleke ukuphuka kwe-distal kwe-supracondylar okuyinkimbinkimbi yesithathu.

I-Global Industry Giants & Leading Brands

1. Stryker Corporation

Umdlali ovelele emitholampilo eyimfihlo ye-tier-1 yase-Spain kanye nezikhungo zokuhlukumezeka zasenyuvesi ezinevolumu ephezulu, i-Stryker yase-US ihlonishwa kakhulu ngobunjiniyela bayo obunembayo kanye nokwesekwa okuqinile kwezohwebo.

• Imikhiqizo Eyisisekelo: Ukushintshwa okuhlanganyelwe, izinkundla ezisizwa ngamarobhothi (Mako), amadivaysi e-neurotechnology, nezinhlelo ezithuthukisiwe zokulungisa ukuhlukumezeka.

• Iphothifoliyo Eyinhloko: I-Gamma4 Trochanteric Nail System kanye ne-T2 Alpha Interlocking Nail System inikeza ukuzinza okuthuthukisiwe komshini kanye nokulungiselelwa kwezinsimbi eziqondiwe.

2. I-DePuy Synthes (Johnson & Johnson MedTech)

Ibambe isikhundla esigxilile kuyo yonke imikhakha yezibhedlela zikahulumeni (i-SNS) nezizimele e-Spain, i-DePuy Synthes isebenzisa amashumi eminyaka ocwaningo lomtholampilo olusekelwa i-AO Foundation.

• Imikhiqizo Eyisisekelo: Izinhlelo eziphelele zokuhlukumezeka, izixazululo zokwakha kabusha ngokuhlanganyela, amadivaysi e-craniomaxillofacial, kanye nama-biomaterials omgogodla.

• Iphothifoliyo Eyinhloko: I-Expert Nail System kanye ne-TFNA (i-Trochanteric Fixation Nail Advanced) isebenzisa ukwelapha okuphathelene nensimbi okulungiselelwe ukuphuka kwe-trochanteric okuyinkimbinkimbi kanye nokuphuka kwamathambo amade.

3. CZMEDITECH

Njengesizinda samandla esaziwayo emhlabeni wonke kumishini yezokwelapha yamathambo, I CZMEDITECH isungule indawo yokunikezela ekhulayo emakethe yaseNingizimu Yurophu, ikakhulukazi ngaphakathi kwe-Spain. Idume ngokuvala igebe phakathi kobunjiniyela bokunemba bezinga eliphezulu laseJalimane kanye nokusebenza kahle kokukhiqiza, inkampani inikeza iphothifoliyo egcwele yokuhlukumezeka ephethe izimvume eziqinile zezokwelapha zamazwe ngamazwe—okuhlanganisa nezitifiketi ze ISO 13485, CE —okuyenza ibe uzakwethu ofanelekayo wezibhedlela ezinkulu ezizimele Universitarios. i-European Public Procurement iziqondiso. ezihlinzeka ngezinsizakalo zezempilo ezizimele kanye nokunakekelwa kwezempilo okuphansi kwe-

• I-Orthopedic Trauma Systems: Ukuxhuma Okuthuthukile Izipikili zangaphakathi komongo wethambo , I-Anatomical Ama-locking plate & Izikulufo , kanye Amasistimu Wokulungisa Wangaphandle.

• Izixazululo Zokulungisa Umgogodla : I-Anterior / Posterior Cervical & Thoracolumbar Systems, Amakheji e-Interbody Fusion, kanye nezinduku zokulungisa umgogodla.

• I-Cranio-Maxillofacial ( CMF ) Izimila : Iphrofayela ye-Titanium Plates ephansi kakhulu kanye Inetha namasistimu okwakhiwa kabusha kobuso.

• Amathuluzi Amandla Okuhlinza Nezinsiza: Ukusebenza okuphezulu kwe Ithuluzi lokubhola amathambo , Amasaha a-Oscillating, namakhithi wezinsimbi zokuvala inzalo ezifanayo.

• Amasevisi Enziwe ngokwezifiso OEM/ODM : Ukukhiqizwa kwemishini yezokwelapha efinyelela ekupheleni eklanyelwe ukucaciswa kwesibhedlela somhlaba wonke.

• Iphothifoliyo Yezinzipho Eziyinhloko kanye Nokuxhumana:

  • I-Femoral Isipikili sangaphakathi komongo wethambo : Yakhiwe kusukela ku-implant-grade Titanium Alloy (Ti-6Al-4V ELI), equkethe i-anatomical curvature elungiselelwe kanye nokulungiselelwa kokukhiya okunezinhlelo eziningi ukuze kuhlinzekwe ukulungiswa okuqinile kokuphuka kwe-shaft okuyinkimbinkimbi.

  • I-Tibial Isipikili sangaphakathi komongo wethambo : Idizayinelwe ngezinketho zokukhiya eziguqukayo eziqhubekayo kanye nephrofayela ekheniwe, ephromotha ukuthwala isisindo kwangaphambi kwesikhathi kanye nokusheshisa ukuphulukiswa kwamathambo.

  • I-Humeral Isipikili sangaphakathi komongo wethambo : Isixazululo esikhethekile somkhawulo ongaphezulu esisiza indlela yokuhlasela kancane, ukunciphisa ukuphazamiseka kwezicubu ezithambile kanye nokuvikela i-rotator cuff.

  • I-Proximal Femoral Nail Antirotation - PFNA : Ifaka isistimu ye-helical blade elungiselelwe iziguli ezikhulile ezinezakhiwo zamathambo e-osteoporotic, okuqinisekisa ukumelana okuphakeme ngokumelene nokusikwa ngesikhathi sokulungiswa kwe-trochanteric fracture.

4. Zimmer Biomet Holdings, Inc.

I-Zimmer Biomet ihlanganisa amapulatifomu okunakekelwa kwezempilo edijithali nobuchwepheshe bokulungisa be-musculoskeletal premium, ihlinzeka ngezinhlelo zezempilo ezinkulu zedolobha lonke eSpain.

• Imikhiqizo Eyisisekelo: Amamethrikhi ezempilo edijithali aqondanisiwe, ukushintshwa okuhlanganyelwe, izingxenyekazi zehadiwe yemithi yezemidlalo, nezifakelo zokuhlukumezeka.

• Iphothifoliyo Eyinhloko: Uhlelo Lwezinzipho Zemvelo luhlanganisa ama-anatomical curvature aklanyelwe ukulingana nezinhlobo ezahlukene zemizwelo yesiguli kuzo zonke izinhlanga zaseYurophu.

5. Smith & Nephew plc

Ngokusebenza okuqondile okusebenzayo kanye namahabhu wezokuthutha aqinile kulo lonke elaseNtshonalanga Yurophu, uSmith & Nephew ozinze e-UK uphumelela kakhulu ekunakekelweni kwamanxeba okuthuthukisiwe nezinhlelo ezikhethekile zokuhlukumezeka.

• Imikhiqizo Eyisisekelo: Izinhlelo ezithuthukisiwe zokulawula amanxeba, imishini yokubona nge-arthroscopy, kanye nehardware ye-orthopedic trauma.

• Iphothifoliyo Eyinhloko: I-TRIGEN Interlocking Nail System inezindawo ezikhethekile eziqediwe ezilungiselelwe ukuphatha isitho esinamandla esiphansi kanye nokuphuka kwe-humeral.

6. B. Braun Melsungen AG (Aesculap)

Imele isiqongo sobunjiniyela baseJalimane abanomlando omkhulu kanye nokuba khona kwebhizinisi e-Spain (ikomkhulu layo e-Rubí, Barcelona), u-B. Braun uhlinzeka izikhungo zomtholampilo zase-Spain ngokulungiselelwa kokuhlukumezeka okuhlala isikhathi eside, okwenziwa ngokunemba.

• Imikhiqizo Eyisisekelo: Amasistimu okwelapha ngokufaka, amathuluzi okuhlinza, izimila zomgogodla, nezingxenyekazi zekhompuyutha zokuhlukumezeka kwesakhiwo.

• Iphothifoliyo Eyinhloko: I-Targon Interlocking Nail System ihlinzeka ngokunemba okuphezulu kokukhiya ukuze kufuneke kwakhiwe kabusha izakhiwo ezinamathambo amade e-femur kanye ne-tibia.

7. I-Medtronic plc

Nakuba ibusa kakhulu kuma-pacemakers nakumadivaysi omgogodla, i-structural osteo-division ye-Medtronic ibhekelela izidingo eziyinkimbinkimbi zokulungisa ukuhlukumezeka okuningi ngaphakathi kwamaqoqo ezempilo esifunda saseSpain.

• Imikhiqizo Eyisisekelo: Izingxenyekazi zekhompuyutha zomgogodla, amapulatifomu okuzulazula athuthukile, amadivaysi e-neurosurgery, nokufakelwa okukhethekile kokuhlukumezeka.

• Iphothifoliyo Eyinhloko: Imiklamo yezinsimbi eguquguqukayo ebhangqwe nokucushwa okuhlanganayo kwendawo yonke efanele ukwakhiwa kabusha kwamathambo okuyinkimbinkimbi.

8. Orthofix Medical Inc.

Orthofix ihamba phambili ekuhlanganiseni amafilosofi okulungisa angaphakathi nangaphandle, enikeza izinketho ezihlukile zokulungisa kabusha kwebhayoloji kochwepheshe bamathambo kulo lonke elase-Spain.

• Imikhiqizo Eyisisekelo: Amafreyimu okulungisa angaphandle, izindlela zokwelapha ezikhuthaza ukukhula kwamathambo, nezihlanganisi ezikhethekile zokwandisa izitho ze-intramedullary.

• Iphothifoliyo Eyinhloko: Izinhlelo ezikhethekile zezingane kanye nezipikili ezincane zabantu abadala ezigxile ekulawuleni ukukhubazeka okunzima kwe-intertrochanteric noma shaft bone.

9. I-Acumed LLC

I-Acumed igxile ekunembeni kwe-anatomical kokuqhekeka komkhawulo ongaphezulu, ukuhlinzeka ngamakhithi akhethekile athandwa ochwepheshe abangaphansi kwehlombe nengalo engenhla ezibhedlela ezizimele eziphambili zase-Spain.

• Imikhiqizo Eyisisekelo: I-Anatomical Ama-locking plate , amasistimu e-osteotomy akhethekile, nezinduku ze-intramedullary eziqondiswe phezulu.

• Iphothifoliyo Eyisisekelo: Izinzipho ze-humeral ze-intramedullary ezisezingeni eliphansi nezinduku zengalo zangaphambili eziklanyelwe ukudambisa ukufakwa kwezicubu ezithambile.

10. I-Globus Medical, Inc.

Ngemuva kokuhlanganiswa kwayo okunephrofayili ephezulu kwakamuva neNuVasive, iGlobus Medical ikhulise ngokushesha ukuhlukumezeka kwayo kanye nokwakhiwa kabusha kwamanethiwekhi okunakekelwa kwezempilo azimele eNingizimu Yurophu.

• Imikhiqizo Eyisisekelo: Izixazululo eziphelele ze-musculoskeletal, i-hardware yomgogodla ethuthukisiwe, kanye nokuzulazula kwe-robotic-assisted trauma.

• Iphothifoliyo Eyinhloko: I-CAPTIVATE Trauma System, equkethe izinsimbi ezilula ezidizayinelwe ukuhlobana okuphumelelayo kwe-femur ne-tibia.

11. I-Wright Medical Group NV (A Stryker Company)

Isebenza phakathi komndeni we-Stryker trauma, ifa le-Wright Medical's umkhawulo ophansi kanye ne-hardware ye-foot-and-ankle ihlala iyisinqumo esiphezulu sokwakhiwa kabusha okuhlangene okuyinkimbinkimbi nokuhlanganiswa eSpain.

• Imikhiqizo Eyisisekelo: Izimila zangaphezulu, ukushintshwa kwamaqakala okuphelele, kanye nokuxhunyelelwa kwamathambo amathambo e-orthobiologic athuthukile.

• Iphothifoliyo Eyinhloko: I-Special Retrograde hindfoot kanye nezinduku zokuhlanganisa iqakala ezidizayinelwe ukuhlinzwa kwe-arthrodesis okuyinkimbinkimbi.

12. I-Aap Implantate AG

I-Aap Implantate ingumkhiqizi ozinze eJalimane oqashelwa ukwethula izimbotshana zesiliva ezintsha kanye nobuchwepheshe bokukhiya i-antibacterial eklanyelwe ukunciphisa izifo ezihambisana nokufakelwa.

• Imikhiqizo Eyisisekelo: Izimila ze-LOQTEQ I-locking plate zomndeni kanye nezimbozwe ngesiliva ze-antibacterial trauma.

• Iphothifoliyo Eyinhloko: Amasistimu wokuhlanganisa ama-titanium angakheniwe futhi aqinile akhelwe ukunciphisa izinkinga zangemva kokuhlinzwa ngesikhathi sokungenelela kwamathambo amade.

13. CarboFix Orthopedics Ltd.

ICarboFix iyingqalabutho kubuchwepheshe be-carbon-fiber, ihlinzeka ngesiphakamiso senani elikhethekile lokuhlinzwa kwamathambo okuhlobene ne-oncology kuzo zonke izikhungo zomdlavuza ezikhethekile zaseSpain.

• Imikhiqizo Eyisisekelo: I-Carbon fiber reinforced polymer plates, izinzipho ze-carbon structural, kanye nokufakelwa kokuhlukumezeka kwe-radiolucent.

• Iphothifoliyo Eyinhloko: I-Piccolo Composite Nails, evumela izithombe ezicacile, ezingenazo izinto ezenziwe nge-artifact ngesikhathi sokulandelela i-oncological kanye nokuqondiswa kokwelashwa ngemisebe.

14. I-MicroPort Scientific Corporation

Isebenzisa ingqalasizinda yezimboni enwetshiwe, i-MicroPort isakaza izinketho ezingabizi kakhulu, zenhliziyo nemithambo yegazi kanye nezamathambo kuwo wonke amashaneli aseNingizimu Yurophu ukuze kuhlangatshezwane nemikhawulo eqinile yesabelomali sesibhedlela.

• Imikhiqizo Eyisisekelo: Ama-stents enhliziyo nemithambo yegazi ahlaseleka kancane, amajoyinti okwenziwa ahlangene, kanye nehardware yokulungisa ukuhlukumezeka okuphelele.

• Iphothifoliyo Eyinhloko: Amasistimu wezinzipho ahlanganisiwe e-intramedullary aklanyelwe ukuphindaphinda, amasu okufaka alula.

15. Wego Ortho (Weigao Group)

I-Wego Ortho ingelinye lamaqoqo ezokwelapha amakhulu kakhulu e-Asia, iletha izifakelo ezinokwethenjelwa kakhulu zebanga lezokwelapha ezihlangabezana nezidingo ezinzima zomtholampilo zaseYurophu.

• Imikhiqizo Eyisisekelo: Imishini yokulungisa umgogodla, amapuleti okuhlukumezeka kwesakhiwo, izitho zokwenziwa ezihlangene, nezinto ezisetshenziswayo zokuhlinzwa eziyinyumba.

• Iphothifoliyo Eyinhloko: Uhlu olubanzi lwezinzipho ezihlala isikhathi eside ezixhumene ze-titanium ezenzelwe izinkontileka zamathenda esifunda e-Spain.

── PRODUCT SELECTION MATRIX ──

Imibuzo Evame Ukubuzwa (FAQ)

Q1: Ingabe izinzipho ze-intramedullary ezidingekayo emakethe yaseSpain zidinga CE Ukumakwa ngaphansi kwe-EU MDR?

Yebo, ngokuphelele. Kulandela ukusetshenziswa okugcwele kwe-European Medical Device Regulation (MDR 2017/745), zonke izinzipho ze-intramedullary ezithengiswa e-Spain kufanele zibe nophawu oluvumelekile lwe CE ngaphansi kwemihlahlandlela ye-MDR . Ikilasi IIb kanye Nekilasi III Izifakelo zamathambo babhekana nokuhlolwa komtholampilo okuqinile, ukucwaningwa kwamadokhumenti okusebenza, kanye nokulandela umtholampilo okusebenzayo kwangemva kwemakethe (PMCF). Abaphathi bokuthengwa kwempahla kufanele baqinisekise ukuthi noma yimuphi umkhiqizi wamazwe ngamazwe, njengokuthi CZMEDITECH , uhlinzeka Ngesimemezelo Sokuvumelana futhi ubhaliswe ngokugcwele ngaphakathi kwesizindalwazi se -EUDAMED .

Q2: Yiziphi izidingo ezithile zokubhalisa nge-AEMPS yaseSpain?

Ngisho noma unophawu olusebenzayo lwe CE , noma iyiphi idivayisi yezokwelapha esabalaliswa ngaphakathi kwe-Spain kufanele kwaziswe i- AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) nge- Aplicación de Comunicación de Comercialización de Productos Sanitarios (CCPS). Abangenisi nabasabalalisi bendawo kumele futhi babe ne- Licencia Previa de Funcionamiento de Instalaciones (Ilayisense Yokusebenza Yangaphambili Yezikhungo), eqinisekisa ukwengamela okugcwele kwasekhaya ngaphambi kokuba imikhiqizo ibhidelwe ngokusemthethweni kumathenda esifunda.

Q3: Kungani izinhlelo ze-Helical Blade (ezifana ne-PFNA) zibekwe eqhulwini ezinsizeni zezempilo zesifunda (isb., i-SERMAS, i-SAS)?

ISpain inenani eliphakeme kakhulu leminyaka yokuphila kanye nezakhiwo ezindala kakhulu zabantu base-Europe, okuholela emthwalweni omkhulu wokuqhekeka kwe-osteoporotic proximal femoral. Izikulufu ze-lag zendabuko zivame ukuhluleka 'ukusika-ngaphandle' komshini ethanjeni elibuthakathaka. Ukuthola amasistimu athuthukile njenge CZMEDITECH 's PFNA, esebenzisa i-helical blade eguquguqukayo ukuze iminyanise esikhundleni sokubhoboza izicubu zethambo, ikhuphula ukuzinza kokujikelezayo futhi ivimbele ngokuphawulekayo ukufundwa nokubuyekezwa kwesibhedlela okumba eqolo—indlela yokukhetha eyinhloko yokuthola amagoli ezinkontilekeni zomphakathi zokunikezela ngeminyaka eminingi.

Q4: Ngabe umthetho wethenda yomphakathi wase-Spain (LCSP) unamthelela muni ekutholweni kwezipikili ze-IM?

Ngaphansi koMthetho Wezinkontileka Zomkhakha Womphakathi wase-Spain ( Ley de Contratos del Sector Público - LCSP ), ukuthengwa kwesibhedlela sikahulumeni akukwazi ukusekelwe enanini kuphela. Amathenda ahlelwa ngokuzungeza Ukuthengwa Okusekelwe Elungwini , lapho ukufaneleka kobuchwepheshe (ukuthobela okubalulekile njengeBanga lesi-5 le-Titanium ASTM F136, i-instrumentation ergonomics, ukulandeleka, kanye nedatha yomtholampilo) kufinyelela ku-50–60% wenani eliphelele. Abakhiqizi abahlinzeka ngamaphrofayili emishini ye-premium ngokusebenza kahle okuthuthukisiwe (okufana ne CZMEDITECH ) babambe iqhaza eliqinile lokuncintisana.

Q5: Yiziphi izilawuli zokulandela umkhondo ezidingekayo ezinzipholweni ze-intramedullary ngaphakathi kwezibhedlela zaseSpain?

I-Spain isebenzisa ngokuqinile uhlelo lwe -UDI (Unique Device Identification) ngaphansi kwegunya le-EU. Zonke izinzipho ze-intramedullary kanye nokuphakathi kokuthi Isikulufu sokukhiya kufanele zibe nesistimu yokulandela ibhakhodi (DataMatrix) ehlinzeka ngokulandeleka okuphelele kusuka kumkhiqizi kuya kurekhodi lezempilo lesiguli elithile (EHR). Abasabalalisi bendawo kufanele bagcine amasistimu okulandelela inqwaba/inqwaba ukuze benze ukukhumbula okusheshayo noma izexwayiso zokuphepha uma zimakwe i-AEMPS.

I-Q6: Ingabe amaqoqo okunakekelwa kwezempilo aseSpain angahlanganisa imigqa yokuhlukumezeka eminingi evela kumkhiqizi oyedwa wamazwe ngamazwe?

Yebo, futhi lokhu kukhuthazwa kakhulu ngezindleko nokuthuthukiswa kokuphatha. Ukuhlanganisa imigqa yokuhlukumezeka ngozakwethu oyedwa oqondile noma umsabalalisi ogunyaziwe womthombo owodwa kuvumela amaqembu ezibhedlela zase-Spanish (njenge-HM Hospitales noma i-Quirónsalud) noma ukuthengwa kwesifunda ukuze kuzuze kumnotho wezinga. Ukuthola okuvela kumkhiqizi ohlanganisiwe ofana ne CZMEDITECH kuvumela inethiwekhi yesibhedlela ukuthi ithole Izinzipho Ze-Femoral, I-Tibial Nails, i-anatomical Ama-locking plate , kanye ne Amathuluzi kagesi ezokwelapha kanyekanye—iqondise ukuphathwa kwe-invoyisi yokuphatha, ukunciphisa izinyathelo zekhabhoni ezihambisana nomthwalo, kanye nokuqinisekisa izakhiwo zenethiwekhi yegumbi lokuhlinza elilinganiselwe.

Isiphetho

Ngenkathi izinhlobo zefa zendabuko zaseNyakatho Melika kanye nase-Europe Emaphakathi ziqhubeka nokuba nezabelo zemakethe ezibalulekile zomlando ezikhungweni ze-tier-1 zase-Spain, izimfuno ezikhulayo zezimali ku- Sistema Nacional de Salud (SNS) ziqhubekisele phambili ukubheka kubakhiqizi asebekhulile, abagunyazwe emhlabeni jikelele. Abahlinzeki abafana ne CZMEDITECH baletha isiphakamiso senani esiphoqelela kakhulu samayunithi okuhlukumezeka esimanje ase-Spain ngokufanisa izitifiketi zezokwelapha zase-Europe ( CE MDR) nezinto zokusetshenziswa zebanga lokufakelwa ezinezakhiwo zokukhiqiza ezithuthukiswe kakhulu.

Isiphetho

Ngenkathi izinhlobo zefa zendabuko zaseNyakatho Melika eCentral Europe ziqhubeka nokubamba amasheya emakethe omlando abalulekile ezikhungweni ze-tier-1 yaseSpain, izimfuno ezikhulayo zezimali ku- Sistema Nacional de Salud (SNS) ziqhubekisele phambili ukubheka kubakhiqizi asebekhulile, abagunyazwe emhlabeni jikelele. Abahlinzeki bayathanda CZMEDITECH iletha isiphakamiso senani esiphoqelela kakhulu samayunithi okuhlukumezeka esimanje ase-Spain ngokufanisa izitifiketi zezokwelapha zase-Europe eziyi-premium ( CE / ISO ) kanye nezinto zokusetshenziswa zebanga lokutshala ezinezakhiwo zokukhiqiza ezithuthukiswe kakhulu.