Ungathembela kithi ngokufakelwa kwezokwelapha kanye nokuthuthukiswa komkhiqizo wedivayisi kusuka kumthombo owodwa wokukhiqiza inkontileka. Ithimba lethu elikhethekile kakhulu lemishini yezokwelapha nonjiniyela bokufakelwa, abaklami, ochwepheshe bemishini kanye nabenzi bamathuluzi abasebenza ndawonye bazosebenza njengesandiso esibalulekile sethimba lakho. Sizokusekela, sisuka ngokushesha nangokunembile sisuka emcabangweni sidlulela ekuklanyweni kokwenziwa, ukuthuthukiswa nokudiliva, sonke ngesikhathi sihlangabezana nezidingo ezibalulekile zokulawula, amashejuli nesabelomali. Onjiniyela bethu bokukhiqiza izinkontileka zemishini yezokwelapha bakusiza ukuthi ukhethe ama-polymer angcono kakhulu nezinsimbi ukuze ulethe ukwenziwa, ukunemba kanye nokuvumelana kwezinto zakho ezibunjiwe. Ngaphezu kwalokho onjiniyela bethu bokufakelwa kwezokwelapha kanye nokuthuthukiswa kwemishini banolwazi ngezinto ezingavamile, ezihlanganisa izinga lokushisa eliphezulu, izinto zebanga ezifakelwayo kanye ne-silicone. Ochwepheshe bethu bezifundo banolwazi kumadivayisi e-Class I, II kanye ne-III. Sinikezela ngamasevisi alandelayo avela ku-FDA ebhalisiwe, ethobela i-21 CFR 820, i-ISO 13485 eqinisekisiwe, indawo ethobelana Nomkhuba Wokukhiqiza Okuhle (GMP):

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• Izimila zezokwelapha namadivayisi aklama nokwenza kahle kusetshenziswa isofthiwe ethuthukisiwe nokulingisa

• Ukukhethwa nokuhlanganiswa kwezinto ezingavuthiwe kanye nezingxenye

• Idizayini ye-Sigma eyisithupha (DFSS) kanye ne-Design for Manufacturing (DFM) kanye ne-Design for Assembly (DFA)

• I-CAD/CAM/CAE

• Ukuhlaziywa kwe-Moldflow / Moldcool

• I-FMEA

• Amakamelo okuhlanza aqinisekisiwe we-ISO kanye ne-cleanroom prototyping namaseli okukhiqiza

• Ukwenza i-prototyping okusheshayo / ukusebenzisa amathuluzi asheshayo: Sikhiqiza izingxenye zomumo oseduze nenethi ezinokubekezelela ukukhiqizwa okuseduze, ezibunjwe ngomshini noma ezibunjiwe futhi zahlanganiswa, ezinsukwini ezimbalwa nje. Inani elikhulu lemisebenzi yesibili iyatholakala

• Buyekeza ubunjiniyela

• Isikhungo sokuhlola esibanzi esinezinto ezisetshenziswayo ezisezingeni eliphezulu zokuhlola nokuhlolwa ngokomzimba, kwemishini, kwamakhemikhali, kagesi, kwamehlo nemvelo.

• Ukubonisana nesitifiketi somkhiqizo

• Izinkonzo zofakazi abangochwepheshe nezinkantolo

• Izinsiza zokubonisana ezihambisana nezidingo zakho

• Ukukhiqizwa kuqhutshwa uma uthanda

• Ukulungiselela idokhumenti

• Izinkonzo zokuqeqesha

 

Izinsiza zethu zezokwelapha ezisheshayo ze-turnkey kanye nezinsizakalo zokukhiqiza ezisheshayo nezokukhiqiza zibandakanya imishini yokubumba yangemuva kwezindlela ezingaphansi nemicu, kanye nokusebenza kwesibili, okufana ne-medical bonding kanye nokushisela, ukuphrinta amaphedi, ukuhlobisa nokuhlanganisa. Singakhiqiza ukunemba okuphezulu okubunjwe nge-micro-mold, ukufaka kanye nezingxenye ezibunjwe ngokweqile. Izinqubo zokubumba ezincane ze-AGS-Engineering ziyakwazi ukufeza ukubekezelelana okuqinile nokukhiqiza izingxenye ezibalulekile ezinesisindo esingaphansi kuka-1 mg. Ukubumba kwethu i-silicone ewuketshezi yezinga lezokwelapha kwenziwa egumbini elihlanzekile le-ISO 7 (ikilasi le-10,000) kanye nokuhlolwa kobuciko kanye nemishini yokuhlola. Izingxenye kanye nemikhiqizo kucutshungulwa ngamasistimu okuphatha izingxenye ezizenzakalelayo lapho kudingeka. Amakhono wethu wokwenza imishini yezokwelapha onesevisi ephelele ahlanganisa:

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• I-Multi-axis CNC machining, i-Swiss-type turning kanye nokugaya okuqondile

• I-EDM yocingo

• Ukuhlanza, ukuqeda kanye nemisebenzi yesibili

 

Imishini yemishini yezokwelapha ihlanganisa zonke izinto zezinga elifakelwayo, okuhlanganisa insimbi engagqwali, i-titanium, i-MP35N, i-nitinol, i-PEEK, ezinye izinsimbi ezikhethekile nama-alloys namapulasitiki.

 

Eminye yemisebenzi yethu yesibili yile:

• Ukushisela kwezokwelapha kwepulasitiki nensimbi kusetshenziswa ukumelana nokushisela, i-ultrasonic kanye ne-laser welding

• Isibopho sebanga lezokwelapha kusetshenziswa izincibilikisi, izinto ezinamathelayo zezokwelapha kanye nokwelapha kwe-UV

• Ukuhlobisa - ukuphrinta kwephedi, isitembu esishisayo

• Ukumaka nge-laser

• Ukumboza ubuso

• Ukulungiswa kwendawo, ukuguqulwa, ukusebenza kahle

• Ukuhlanzwa kwezokwelapha nokuvala inzalo kusetshenziswa amasu anhlobonhlobo afana nokugeza nge-ultrasonic, ukuhlanza i-plasma surface... njll.

 

Ama-prototypes akho nemikhiqizo ingahlanganiswa futhi ihlanganiswe ngokuvumelana nezindinganiso zezokwelapha. Amandla ethu okuhlanganisa idivayisi yezokwelapha kanye nokupakisha ahlanganisa:

• Izixazululo zokuhlanganisa ezenziwa ngesandla nezizenzekelayo

• Ukukhethwa kwezinto zokupakisha nokuhlanganiswa, ukuphathwa kwe-supply chain

• Idizayini engaphandle kweshalofu kanye nokupakishwa kwangokwezifiso nokuthuthukiswa ukuze kuhlangatshezwane nezidingo zakho ezihlukile

• Ithreyi nesikhwama kanye nokuvala okungenangqondo

• Ukuphrinta ilebula

• Ukupakisha okuzenzakalelayo ngokuphrinta okusemgqeni

• Ukuphrinta kwebhakhodi nokuqinisekisa

• Ukuhlola ukuvuza

• Ukuphatha inzalo

• Ukuhlaziywa kwedatha nokubika

 

Uma unentshisekelo enkulu emandleni ethu okukhiqiza ajwayelekile esikhundleni sobunjiniyela, sincoma ukuthi uvakashele isayithi lethu lokukhiqiza ngokwezifisohttp://www.agstech.net

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Imikhiqizo yethu yezokwelapha egunyazwe yi-FDA kanye ne-CE ingatholakala ku- imikhiqizo yethu yezokwelapha, izinto ezisebenzisekayo nesayithi lemishini.http://www.agsmedical.com