Ukuba ngumthengisi wezonyango ezilahlekileyo: Isikhokelo esibanzi

Intshayelelo:

Ekuvukeni kweemfuno zempilo yehlabathi, isidingo sokuthenjwaIzibonelelo zezoNyango oluNcileyoikhule kakhulu. UkusukaiigloveskwayeIseti yokuqokelelwa kwegazi to Izirinjisi ezinokuchithekakwayeIinaliti ze-huberEzi mveliso zibalulekileyo zidlala indima ebalulekileyo ekuqinisekiseni ukhuseleko kunye nentlalo-ntle yabasebenzi bezempilo kunye nezigulana ngokufanayo. Eli nqaku lijolise ekunikezeleni isikhokelo esibanzi sendlela yokuba limpumelelo ekuboneleleni ngempumelelo kwezonyango, ukugubungela ingqalelo ebalulekileyo, amanyathelo, kunye nemiceli mngeni echaphazelekayo kulo mzi mveliso.

1. Yenza uphando lwentengiso:

Ngaphambi kokuqala kohambo lokuba luncedo lwezonyango olunokuchitheka, uphando olucokisekileyo lubalulekile. Vavanya imfuno yangoku kwishishini lezempilo, kubandakanya neemfuno ezithile zezibhedlele, iiklinikhi, kunye namanye amaziko onyango. Chonga izithuba ezinokubakho kwintengiso kwaye ubone ukuba zeziphi iimveliso ezikwimfuno ephezulu.

2. Cwangcisa isicwangciso seshishini kunye nesicwangciso:

Phuhlisa isicwangciso seshishini kunye nesicwangciso-qhinga sokukhokela imisebenzi yakho. Chaza imakethi yakho ekujoliswe kuyo, amaxabiso okhuphiswano, iindlela zokuthengisa, kunye nokuhambisa amajelo. Cinga ngezinto ezinje ngokufumana, uLawulo lwee-INTLOTER, uLawulo loMgangatho, kunye nokuthobela imigangatho yolawulo. Isicwangciso esomeleleyo seshishini siya kukunceda uzibeke iinjongo ezicacileyo kwaye uhambise imeko yokhuphiswano.

3. Yakha ubudlelwane nabavelisi kunye nabathengisi:

Yenza ubuhlakani kunye nabavelisi abathembekileyo kunye nabathengisi abanokubonelela ngemveliso yezonyango eqinileyo kwaye ejolise ekunciphiseni. Ukuqhutywa kokukhuthala okufanelekileyo ukuqinisekisa ukuba bayayifezekisile imigangatho efanelekileyo kunye nemigangatho yolawulo. Seka ubudlelwane obuqinileyo kunye nabathengisi bakho ukuqinisekisa i-chain eqingqiweyo nenempumelelo.

4. Ukuqinisekiswa komgangatho kunye nokuqinisekiswa:

Kumzi-mveliso wokhathalelo lwempilo, ukuqinisekiswa komgangatho kubaluleke kakhulu. Qinisekisa ukuba iimveliso ozinikelayo zihlangabezana nemigangatho efunekayo yokhuseleko kunye nentsebenzo. Fumana inkcazo eyimfuneko, njenge-ISO 13485 okanye imakisha, ukubonakalisa ukuthotyelwa kwemigaqo yeshishini. Ukumiliselwa rhoqo kolawulo oluthe tye ukuze ugcine ukungangqinelani kunye nokuthembeka kwiminikelo yakho yemveliso.

5. Izixhobo kunye nolawulo lweempahla:

Izinto ezifanelekileyo zolawulo olufanelekileyo kunye nolawulo lwe-inventri zizinto eziphambili zokuba ngumthengisi ophumeleleyo wonyango ophumeleleyo. Phuhlisa iinkqubo zokuhambisa inzaliseko yokuzaliseka, ukulungisa, kunye nokuhanjiswa kwangexesha. Gcina inqanaba le-inventrim elungileyo ukuthintela ukhuseleko okanye iindleko zokugcina ngaphezulu. Cinga ngokufezekisa inkqubo yolawulo lwe-Inventor eyomeleleyo ukulandelela ukufumaneka kwemveliso kunye nokusebenza ngokudibeneyo.

I-6. Ukuthengisa kunye nokuthengisa:

I-CRAFF Isicwangciso-qhinga sentengiso esibanzi sokuthengisa kunye nezentengiso esibanzi sokukhuthaza ngokufanelekileyo iimveliso kunye neenkonzo zakho. Seka ubukho be-intanethi ngewebhusayithi ye-intanethi, iikhathalogu ezikwi-intanethi, kwaye uzibandakanya amaqonga eendaba zentlalo. Ukuya kwimiboniso yoRhwebo kwezoqoqosho kunye neenkomfa zothungelwano olunabathengi abanokubakho kwaye babonise uluhlu lwemveliso yakho. Yakha ubudlelwane kunye nabasenzi abaphambili kwishishini lezempilo, kubandakanya nezibhedlele, iikliniki, kunye nokuthenga amasebe.

7. Ukuthobela kunye neMigaqo:

Ukuthobela iimfuno zomthetho kunye nemigangatho kubalulekile ukuba afumane ilungelo lokugcina izinto zonyango olunokuchitheka. Hlala uhlaziyiwe ngemigaqo efanelekileyo, njenge-FDA yezikhokelo ze-FDA okanye imigangatho ethile yezizwe ngezizwe. Qinisekisa ukuba iimveliso zakho zineelebheli, zipakishwe, kwaye zihamba kunye namaxwebhu ayimfuneko. Gcina unxibelelwano olusondeleyo kunye nabasemagunyeni abalawulayo ukuze bakwaziswe malunga naluphi na utshintsho okanye uhlaziyo.

8. Ukuphuculwa okuqhubekayo kunye nolwaneliseko lwabathengi:

Zabalazela ukuphuculwa okuqhubekayo kuwo onke amabakala eshishini lakho. Funa ingxelo evela kubathengi kunye nabasebenzi bezempilo ukuze baqonde iimfuno zabo kunye nezinto abazithandayo. Ukuqhubeka nokuhlaziya kwaye kwandise iminikelo yakho yemveliso esekwe kwiimfuno zentengiso. Nika iinkonzo ezigqwesileyo zabathengi, kubandakanya nonxibelelwano olukhawulezayo, ukuhambisa ngexesha elifanelekileyo, kunye nokusombulula iingxaki.

ISIQINISEKISO:

Ukuba ngumthengisi wezonyango okulahlekileyo kufuna ucwangciso ngononophelo, ukuzinikela kunye nokuzibophelela kumgangatho. Ngokwenza uphando olufanelekileyo lwentengiso, ukuseka ubudlelwane obuqinileyo, ukuqinisekisa ukuqinisekiswa komgangatho, kunye nokuphumeza iindlela ezifanelekileyo zezinto kunye neendlela zokuthengisa, ungazibeka njengomthengisi othembekileyo nothembekileyo kwishishini lezempilo. Hlala usebenze ngokuhlengahlengiswa ekutshintsheni kwemigaqo kunye neemfuno zentengiso, kwaye uqhubeke ngokugqwesa ukuba uhlangabezane neemfuno zempilo kunye namaziko. Ngonyamezelo kunye nendlela yomthengi-yesenti, unokuphumelela kule ntsimi ibalulekileyo nenomvuzo.