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e sa Sekisetseng Boleng Taolo ea

Litlhahlobo sethaleng se seng le se seng sa ts'ebetso. Ha re tlohele letho ka tšohanyetso ha ho tluoa tabeng ea tšireletseho ea mokuli le katleho ea ho buuoa.

ISO 13485
CE Mark
FDA e Ngolisitsoe
CNAS e amohetsoe
Boitlamo ba rona

ea Zero Sekoli
Mamello

Ho barekisi ba rona ba lefats'e: Ho sebelisana le XC Medico ho bolela hore ha ho na matšoenyeho mabapi le ho hopola sehlahisoa kapa ho hloleha hoa bongaka . Hajoale, baetsi ba lisebelisoa tsa bongaka ba lumellanang le molao le ba tšoanelehang ba tlameha ho sebelisa sistimi e kopanang le ISO 13485. Re motlotlo ho feta litekanyetso tsena.

Ho tloha ho lisebelisoa tse tala ho ea ho thepa e tsoang kantle, tsamaiso ea rona ea tlhahlobo ea mekhahlelo e mengata e tiisa hore implant e 'ngoe le e' ngoe e sebetsa hantle ka har'a vivo.

ISO 13485
Tsamaiso ea Boleng
Mekhoa ea ho laola boleng ba lisebelisoa tsa bongaka bakeng sa merero ea ho laola.
Pakiloeng
CE Mark
Tumellano ea Europe
Ho lumellana ka botlalo le litekanyetso tsa polokeho ea EU, bophelo bo botle le ts'ireletso ea tikoloho.
E sebetsa
FDA e Ngolisitsoe
US Market Access
E ngolisitsoe ho US Food and Drug Administration bakeng sa ho kena 'marakeng oa lisebelisoa tsa bongaka.
Ngodisitsoe

The 4 Stage Inspection Process

Kemiso ea nako e tiileng e netefatsang phetheho e felletseng ho tloha ho lisebelisoa tse tala ho isa ho sephutheloana sa ho qetela.

01

Tlhahlobo ea Raw Material

'Boleng bo qala mohloding.'

Netefatso e tiileng ea titanium ea boemo ba bongaka e kenang le tšepe e sa hloekang. Sehlopha se seng le se seng se lekoa ka matla bakeng sa sebopeho sa lik'hemik'hale le thepa ea mochini pele e kena moleng oa tlhahiso.

Setifikeiti sa Material: Ho netefatsa litifikeiti tsa tlhahlobo ea leloala khahlano le litekanyetso tse thata tsa ISO le ASTM.
Spectrochemical Analysis: Ho netefatsa sebopeho sa lik'hemik'hale se nepahetseng bakeng sa biocompatibility e felletseng.
Tlhahlobo ea Raw Material
02

Ts'ebetsong ea Ts'ebetso

'Ho nepahala ho laolwa boemong ba micron.'

Ho tšoara mamello ho li-microns. Tlhokomelo e tsoelang pele nakong ea ts'ebetso ea mochini e netefatsa hore karolo e 'ngoe le e 'ngoe e fihlela litlhoko tse tiileng tsa maemo.

Real time Tracking: IPQC e etsoa ka lisebelisoa tsa ts'ebetso le mekhoa ea ho sebetsa.
Kenahano ea Hang-hang: Tlhahlobo ea tekheniki le merero ea tokiso bakeng sa lintho tse sa tloaelehang.
Ts'ebetsong ea Ts'ebetso
03

Comprehensive Checks

'Seo u se bonang ke phetheho e phethahetseng.'

Tlhahlobo ea boleng le pono ea thepa e felileng e etsoa ho latela melaoana ea ISO, ho sebelisoa sekhahla sa sampole sa 50%. Ho sebelisa CMM e tsoetseng pele le li-optical comparator ho netefatsa li-geometri tse rarahaneng.

Imported Precision: E na le lisebelisoa tse phahameng tsa tlhahlobo tse tsoang kantle ho naha.
Ho Nepaha ha Microscopic: Ho Sebelisa CMM, Surface Roughness Tester, le 3D Topography.
Comprehensive Checks
04

Tiiso e Matla

'E hlahlobiloe ho feta meeli ea bongaka.'

Ho netefatsa bots'epehi ba sebopeho, re etsisa likhatello tsa vivo 'me re etsa liteko tsa mokhathala ka nako e sa feteng habeli litekanyetso tsa kliniki, tse tlatselletsoang ke torsion le tiisetso ea matla.

Setsi se Seholo: 1,000 m² e inehetseng ea Mechanics Laboratory.
Tiisetso ea Tšireletso: Ho netefatsa hore li-implants ha ho mohla li hlōlehang ka har'a 'mele oa mokuli.
Tiiso e Matla
Basebetsi ba Theknoloji

E tsamaisoa ke ea Lefatše
Theknoloji ea Teko

Re tsetela haholo thepa ea tlhahlobo e tsoetseng pele ka ho fetisisa lefatšeng ho netefatsa hore ho buuoa ka nepo.

TSIETSA
Jeremane
3D Topography
MOTSAMAI
United States
Teko ea Mokhathala
MITUTOYO
Japane
Bokhopo ba Sekaho
HEXEON
Sweden
Litekanyo tsa CMM
TA
United States
Teko ea Mechini

Eba le maemo a XC Medico

Sheba taolo ea rona ea boleng e sebetsa. Behela leeto la feme kapa u kope litlaleho tsa rona tse felletseng tsa liteko.

 
 

Ikopanye le Litsebi tsa XC Medico

Na u se u itokiselitse ho ntlafatsa phepelo ea hau ea masapo? Kenya litlhoko tsa sehlahisoa sa hau kapa u kope lethathamo la rona le felletseng ka tlase. Lienjineri tsa rona tse inehetseng tsa thekiso li tla arabela nakong ea lihora tse 12 ka litharollo tse lokiselitsoeng le linako tse nepahetseng tsa ho etella pele.

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    xc-letshwao-la bongaka
    Joalo ka motho ea tšeptjoang lefatšeng ka bophara Moetsi oa Li-Implants tsa Orthopedic , XC Medico e khethehile ho fana ka litharollo tsa bongaka tsa boleng bo phahameng, ho akarelletsa le Trauma, Spine, Joint Reconstruction, le li-implants tsa Meriana ea Lipapali. Ka lilemo tse fetang 18 tsa boiphihlelo le setifikeiti sa ISO 13485, re ikemiselitse ho fana ka lisebelisoa tsa ho buoa tse entsoeng ka nepo le li-implant ho barekisi, lipetlele le balekane ba OEM/ODM lefatšeng ka bophara.

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