Uwuvavanya njani uMgangatho wokuVelisa we-Endoscopy Factory

Indlela yokuvavanya umzi-mveliso we-endoscopy ifuna isakhelo esivavanya ukuthotyelwa kwemithetho, ulawulo lwemveliso, amandla obunjineli, kunye nolawulo lwababoneleli. Ukuthengwa kwesibhedlele kunye nabasasazi bezonyango, oku kunyamekela kuqinisekisa ukhuseleko lwesigulane, ukuthembeka kwesixhobo, kunye neendleko ezipheleleyo zobunini. Esi sikhokelo sichaza iintsika eziphambili zophicotho lweenkqubo zomgangatho weqabane elinokubakho kunye nokusebenza kwexesha elide, ukuhamba ngaphaya kokucaciswa kweenkqubo ezisisiseko.

Ukuphonononga i-Endoscopy Factory: IMigangatho engundoqo yokuVelisa

Ukuvavanya ukugqwesa kwimveliso kufuna uphononongo olucokisekileyo lweenkqubo zomgangatho osisiseko kunye nemigangatho yemveliso.

Isakhelo sokuThotyelwa koLawulo

• Isiqinisekiso esisebenzayo se-ISO 13485 kwiinkqubo zokwenza izixhobo zonyango

• Ubhaliso oluyimpumelelo lwe-FDA kunye namaxwebhu okukhutshwa kwemarike

• Ukuthotyelwa kwe-EU MDR kunye nokulungiswa kweefayile zobugcisa

• Imigangatho yokhuseleko yombane yamazwe ngamazwe kuquka i-IEC 60601 series
  
  

Ulawulo lweNdawo yeMveliso

• Iiprothokholi eziqinisekisiweyo zokuhlelwa kwegumbi elicocekileyo kunye nokugcinwa kwazo

• Iinkqubo zokubeka iliso kokusingqongileyo kulawulo lobushushu kunye nokufuma

• Amanyathelo athile okuthintela ukungcoliseka

• Ukuqinisekiswa kokuqinisekisa kunye nokupakishwa kwemfezeko yovavanyo

UbuNjineli obuGqwesileyo kwi-Endoscopy Manufacturing

Umgangatho wokwenziwa kwemveliso udlulela ngaphaya kokuthotyelwa ukuquka ubuchule bobugcisa kunye namandla okuvelisa izinto ezintsha.

Uphando kunye namandla oPhuhliso

• Ukuqulunqwa kweqela lobunjineli bezinto ezininzi kunye nobuchule

• Ukuphunyezwa kwenkqubo yolawulo loyilo kunye namaxwebhu

• Indlela yokulawula umngcipheko ngokwe-ISO 14971

• Ubunakho bePrototyping kunye neeprothokholi zovavanyo lokuqinisekisa

IiNkqubo zoMveliso eziPhambili

• Ukuphunyezwa kweenkqubo zokuhlola okuzenzekelayo

• Ukuchaneka komatshini kunye neendlela zokuhlanganisa

• Uncedo lwerobhothi kwimisebenzi yendibano enzima

• Ukubekwa esweni kwemveliso yexesha langempela kunye nokuqokelela idatha

Supply Chain Integrity for Medical Device Production

Uqinisekiso olubanzi lomgangatho lufuna ukugqwesa kulo lonke ikhonkco lokubonelela kunye ne-ecosystem yokuvelisa.

Ulawulo loMgangatho woMboneleli

• Ukucaciswa kwemathiriyeli ekrwada kunye neenkqubo zokuqinisekisa

• Iinkqubo zophicotho lwababoneleli kunye nokujongwa komsebenzi

• Iinkqubo zokulandelelwa kwecandelo kunye nolawulo lweqashiso

• Iiprothokholi zokuhlola ezingenayo kunye neendlela zokwamkelwa

Isiqinisekiso soMgangatho weMveliso

• Kwinkqubo yokukhangela ulawulo lomgangatho

• Ukuphunyezwa kolawulo lwenkqubo yamanani

• Uvavanyo lokugqibela lwemveliso kunye nokuqinisekiswa kokusebenza

• Iinkqubo zokuphatha izinto ezingahambelaniyo

Inkxaso ye-Lifecycle evela kwi-Endoscopy Factory Partner yakho

Umgangatho wokwenziwa kwemveliso ezinzileyo ubonisa ukuzibophelela ngenkxaso eqhubekayo kunye nophuculo olucwangcisiweyo.

Izibonelelo zeNkxaso yoMthengi

• Ukufumaneka kwenethiwekhi yenkxaso yobugcisa behlabathi

• Ulungiso kunye namandla enkonzo yokulondoloza

• Uqeqesho lwezonyango kunye nezibonelelo zemfundo

• Ulawulo loluhlu lwezinto ezisetyenzisiweyo
  
  

Ukujongwa koMgangatho wokuSebenza

• Ukuphunyezwa kwenkqubo yokubeka iliso emva kwemarike

• Ukuqokelelwa kwengxelo yabathengi kunye nohlalutyo

• Ukulandelela ukusebenza kommandla

• Amaxwebhu enkqubo yokuphucula rhoqo
  

Uvandlakanyo olubanzi lomzi-mveliso we-endoscopy lufuna uvavanyo kuwo onke amanqanaba amaninzi okugqwesa kwimveliso. Le ndlela icwangcisiweyo yenza izigqibo zentsebenziswano ezinolwazi ezisekelwe kwisakhono esibonakalisiweyo kunye nokusebenza okusemgangathweni okuzinzileyo.