Ukufumana izixhobo zonyango · Isikhokelo esisebenzayo somthengi
Ukuvavanya abavelisi bezixhobo zotyando kufuna ngaphezulu kokuthelekisa ubungakanani bekhathalogu kunye nexabiso leyunithi. Uphononongo oluthembekileyo luvavanya ubunikazi bomthetho bomenzi, inkqubo yomgangatho, imeko yokulawula imveliso ethile, izixhobo, ulawulo lwenkqubo, ukulandeleka, iisampulu, ukusebenza kokuhanjiswa, kunye nenkxaso yasemva kwentengiso. Olu luhlu lokutshekisha olunamanqaku ali-12 lujika ezo mfuno zibe yinkqubo ephindaphindwayo yokukhetha umthengisi.
Umvavanya Njani uMvelisi Wezixhobo Zoqhaqho?
Qala ngokucaciswa kwemfuneko yomsebenzisi ebhaliweyo, emva koko uvavanye umviwa ngamnye kwizigaba ezine: ukuphononongwa koxwebhu, ingxoxo yobugcisa, uvavanyo lwesampulu, kwaye-apho umngcipheko uthethelela-uphicotho olukude okanye olukwisiza. Musa ukuvuma umboneleli ngokusekelwe kuphela kwisiqinisekiso sePDF, ibango lewebhusayithi, okanye isampulu eyamkelekileyo ebonakalayo.
Eyona mpendulo imfutshane imfutshane: khetha umenzi onikezela ngobona bungqina buqinileyo besixhobo sakho kunye nentengiso-hayi inkampani enoluhlu olude lwemveliso okanye eyona kowuteshini isezantsi.
Chaza iiMfuno zakho phambi kokuQhagamshelana naBaboneleli
Umniki-nkonzo akanakubonelela ngekowuteshini enentsingiselo okanye ipakethe yokuthotyelwa de imveliso ekujoliswe kuyo ichazwe ngokucacileyo. Lungiselela uxwebhu olufutshane lweemfuno phambi kokwenza uluhlu olufutshane.
- Isixhobo kunye nokusetyenziswa okucetywayo: igama lesixhobo, inkqubo, imo enokusetyenziswa kwakhona okanye yokusetyenziswa kanye, nokuba inikezelwe yodwa okanye njengenxalenye yenkqubo yokufakelwa.
- Imakethi ekujoliswe kuyo: amazwe athengiswayo, ulwahlulo lwesixhobo, indlela yobhaliso esebenzayo, ulwimi, iileyibhuli, kunye neemfuno zokungenisa elizweni okanye ezigunyazisiweyo-ummeli.
- Inkcazo yobugcisa: imilinganiselo, ukunyamezelana, ibakala lemathiriyeli, ubulukhuni, ukugqitywa komphezulu, ijometri yojongano, imizobo, kunye neendlela zovavanyo.
- Ukusetyenzwa: ukucocwa kwemeko, ukupasa, ukupakishwa, ubume bokuvala inzala, ukuhambelana nokuvala inzala, kunye nemiyalelo eqinisekisiweyo yokuhlaziya kwakhona apho kufanelekileyo.
- Umda worhwebo: umthamo wengqikelelo, iodolo yokuqala, ixesha lokukhokela ekujoliswe kulo, ukupakishwa kokupakishwa, ileyibhile yabucala, kunye namaxwebhu afunekayo.
Ukuphonononga umvelisi Iindidi zeemveliso ze-orthopedic zinokunceda ukumisela ukuba umda wayo wemveliso oqhelekileyo uhambelana nokuthenga okucwangcisiweyo. Ububanzi bekhathalogu iyodwa, nangona kunjalo, ayibonakalisi ubuchule baso sonke isixhobo esidwelisiweyo.
Uluhlu olunamanqaku ali-12 aBavelisi bezixhobo zoTyando
- Qinisekisa umenzi osemthethweni kunye noxanduva lwesayithi Chonga ukuba ngubani umnini wesixhobo, owenza icandelo ngalinye, owenza ukugqiba kunye nokupakisha, kwaye ngubani okhupha imveliso egqityiweyo. Rekhoda iidilesi kunye neenkqubo ezibalulekileyo zangaphandle.
- Qinisekisa inkqubo yolawulo lomgangatho Cela isiqinisekiso sangoku se-ISO 13485 kwaye uqinisekise igama lombutho, idilesi yokuvelisa, umda wesiqinisekiso, iqumrhu elikhupha isatifikethi, ulwamkelo, ubume besatifikethi, kunye nomhla wokuphelelwa.
- Qinisekisa ugunyaziso lwentengiso olungqale kwimveliso Tshatisa eyona mveliso, imodeli, usetyenziso olucetyiweyo, ukuhlelwa, kunye nomvelisi osemthethweni kumaxwebhu afunekayo kwimarike yendawo nganye. Ukubhaliswa kwenkampani akufani nokukhutshwa kwemveliso okanye ukuvunywa.
- Ukuphonononga imathiriyeli kunye nolawulo lwababoneleli Ifuna ukucaciswa kwemathiriyeli kunye nezatifikethi, ulawulo lwababoneleli oluvunyiweyo, uhlolo olungenayo, ulwahlulo lwamaqashiso, kunye nenkqubo yokuphatha ukutshintshwa okanye utshintsho lwemathiriyeli.
- Vavanya amandla okuvelisa Qinisekisa ukuba ukwenza izixhobo, ukubumba, unyango lobushushu, ukuwelda, ukupolisha, ukugqithiswa, ukugquma, ukuhlanganisa, kunye nokuhlola amandla ahambelana nemveliso. Qinisekisa ukuba ngawaphi amanyathelo anikezelwa ngaphandle kunye nendlela alawulwa ngayo.
- Vavanya uqinisekiso lwenkqubo kunye nolungelelwaniso Buza ukuba iinkqubo ezizodwa ziqinisekiswa njani kwaye uhlolo, itorque, ubukhulu, umbane, kunye nezinye izixhobo zokulinganisa zilungelelaniswa kwaye zigcinwe njani.
- Uvavanyo lokulandelelwa kunye nolawulo lwamaxwebhu Khetha isampuli eninzi kwaye ucele umvelisi ukuba ayilandele emva kwimathiriyeli ekrwada, umhambi okanye ushicilelo lwendlela, uhlolo, ukungathotyelwa, ukuleyibhile, ukupakishwa, kunye nokukhupha imvume.
- Vavanya ukusebenza kobugcisa kunye nokusebenziseka Vuma iisampulu ezichasene nemizobo kunye neendlela zokusetyenziswa kwezinto ezifana nokufaneleka, ukulungelelaniswa, ukubamba, ukusika ukusebenza, ukuhanjiswa kwetorque, ukuhambelana kojongano, i-ergonomics, kunye nokuphindaphinda ukusetyenzwa.
- Ukuphonononga ukucocwa, ukupakishwa, kunye noxanduva lokuvala inzala Cacisa ukuba ngaba izixhobo zibonelelwe ngokungeyontsholongwane okanye azinyumba, leliphi iqela eliqinisekisa ukucocwa kunye nokuvalwa, kwaye yeyiphi ukupakishwa kwemfezeko, ubomi beshelufa, i-bioburden, kunye nobungqina bokuleyibheli obusebenzayo.
- Vavanya ukuyila kunye nokulawulwa ngokwezifiso Kumsebenzi we-OEM / ODM, ukuphonononga igalelo loyilo, ulawulo lomngcipheko, imizobo, ukuqinisekiswa, ukuqinisekiswa, ipropathi yengqondo, ukuvunywa kwesampulu, ukudluliselwa koyilo, kunye noxanduva lokulawula utshintsho.
- Ukulinganisa umthamo kunye nokuthembeka konikezelo Jonga ixesha lokwenyani lokukhokela, imiqobo yomthamo, ubungakanani bomyalelo obuncinci, isitokhwe sokhuseleko, ukuphathwa kwentelekelelo, ukuqinisekiswa komyalelo, ukupakisha ukuchaneka, amaxwebhu athumela ngaphandle, kunye nezicwangciso zokubuyisela ukulibaziseka.
- Ukuphonononga izikhalazo, i-CAPA, iwaranti, kunye nokuqhubekeka Qinisekisa ukunyuka kwesikhalazo, uhlalutyo lwengcambu, inyathelo lokulungisa kunye nokuthintela, isenzo sentsimi okanye inkxaso yokukhumbula, iinxalenye ze-spare, ukulungiswa, imigaqo yewaranti, kunye nokuqhubeka kweshishini.
Indlela yokuqinisekisa aBango loMgangatho kunye noLawulo
I-ISO 13485 ngumgangatho wenkqubo esemgangathweni
I-ISO 13485 ixela iimfuno zenkqubo yolawulo lomgangatho kwimibutho ebandakanyeka kumjikelo wobomi besixhobo sonyango. Bubungqina obunentsingiselo xa isatifikethi sisemthethweni kwaye umda waso ugubungela umbutho ofanelekileyo, indawo kunye nemisebenzi. Ayinabungqina ngokwayo bokuba yonke imveliso ekwikhathalogu ibhalisiwe, ifanelekile ngokwezonyango, okanye igunyaziswe kwimarike yakho.
Cela isatifikethi esipheleleyo kunelogo enqanyulweyo. Qinisekisa ngequmrhu lezatifiketi okanye uvimba wedatha kawonke-wonke apho kunokwenzeka, kwaye uthelekise igama lenkampani kunye nedilesi ngokuchasene neekowuteshini, ii-invoyisi, izibhengezo, iilebhile, kunye neerekhodi zemveliso.
Ukumakishwa kwe-CE kufuneka kuhambelane nesixhobo kunye nendlela ye-EU MDR
KwiManyano yaseYurophu, misela ulwahlulo lwesixhobo kunye nendlela yokuhlola ukuthobela esebenzayo phantsi koMgaqo weSixhobo sezoNyango. Ukuphonononga isiBhengezo se-EU sokuThotyelwa kwaye, xa iklasi ifuna ukubandakanyeka komzimba owaziyo, isatifikethi esisebenzayo kunye neenkcukacha zomzimba ozisiweyo. Qinisekisa ukuba usapho lwemveliso, umenzi osemthethweni, Isiseko se-UDI-DI apho kufanelekileyo, injongo ekujoliswe kuyo, kunye nolungelelwaniso lomda wesatifikethi.
Ukubhaliswa kokusekwa kwe-FDA akusiyo imvume ye-FDA
I-FDA ichaza ngokucacileyo ukuba ukubhaliswa kokusekwa kunye noluhlu lwezixhobo alubonisi ukuvunywa, ukukhutshwa, okanye ugunyaziso. E-United States, jonga ulwahlulo lwesixhobo kunye nokuba eso sixhobo sifuna 510(k) imvume, imvume ye-PMA, isigunyaziso se-De Novo, okanye sikhululekile. Qinisekisa irekhodi yesiseko sedatha efanelekileyo kunokuxhomekeka kwibheji 'ebhalisiweyo ye-FDA'.
| Uxwebhu okanye ibango | Into ekufuneka | uyiqinisekise |
|---|---|---|
| Isiqinisekiso se-ISO 13485 | Igama elisemthethweni, indawo, umda, umkhuphi, ukuvunywa, isimo, kunye nokuphelelwa kwexesha. | Ugunyaziso oluthile lwemarike okanye ukufaneleka kweklinikhi. |
| Ukumakishwa kwe-CE / amaxwebhu e-EU | Isazisi sesixhobo, ulwahlulo, isibhengezo, ibhodi eyazisiweyo apho kufanelekileyo, kunye nokhuseleko lwe-MDR. | Ugunyaziso ngaphandle kwesakhelo esisebenzayo saseYurophu. |
| Ukubhaliswa kwe-FDA / uluhlu | Ukusekwa kwangoku kunye noluhlu lwedatha kunye nendlela yolawulo esebenzayo yesixhobo. | Ukuvunywa kwe-FDA, ukukhutshwa, ukugunyaziswa, okanye ukuqinisekiswa okuzimeleyo. |
| Ingxelo yovavanyo | Ilebhu evunyiweyo apho kufanelekileyo, isazisi sesampulu, indlela, indlela yokwamkelwa, umhla, kunye nesiphumo. | Ukuba yonke imveliso iyafana nesampulu evavanyiweyo. |
| Isiqinisekiso sokuhlalutya / ukuhambelana | Idata ethile, ingcaciso, iziphumo, igunya lokukhupha, kunye neziphawuli ezinokulandeleka. | Ukusebenza kwenkqubo yomgangatho wonke ngaphandle kweerekhodi ezixhasayo. |
Yintoni omele uyijonge ngexesha loMzi-mveliso okanye uPhicotho loMgangatho?
Umngcipheko umisela ubunzulu bophicotho. Isixhobo esisemgangathweni esisezantsi sinokuvavanywa ngamaxwebhu, uphicotho lwevidiyo ephilayo, kunye nokuhlolwa kwesampulu. Iseti yesixhobo esitsha esifakelwayo esihambelanayo, isixhobo esingenazintsholongwane, inkqubo ebalulekileyo yangaphandle, okanye inkqubo yexesha elide eleyibhile yabucala inokuxhasa uphicotho lwendawo kunye nokuqinisekiswa okubanzi ngakumbi.
Uphicotho oluluncedo lulandela ulandelelwano lokwenyani okanye iqashiso ngoncedo. XC Medico's ulawulo lomgangatho kunye nohlolo lokuhlola lunika umzekelo weendawo zenkqubo abathengi banokucela ukubona.
| Indawo yophicotho | Ubungqina bokucela | Umzekelo wombuzo |
|---|---|---|
| Izinto ezingenayo | Uluhlu lwababoneleli abavunyiweyo, isatifikethi semathiriyeli, uhlolo olungenayo, kunye neerekhodi zokuvalelwa. | Iqashiso lezinto eziphathekayo lidityaniswa njani nesixhobo esigqityiweyo? |
| Ulawulo lwemveliso | Imiyalelo yomsebenzi, iirekhodi zomzila, iinkqubo eziqinisekisiweyo, isiqinisekiso somsebenzisi, kunye nokuhlolwa kwenkqubo. | Ingaba zifunyaniswe njani kwaye ziqulathwe njani izitenxa? |
| Umlinganiselo | Ubume bokulinganisa, indlela yokulinganisa, amandla okulinganisa, kunye neerekhodi zokuhlola. | Ngaba ukunyamezela isixhobo kunokulinganiswa ngokuthembekileyo? |
| Imveliso engahambelaniyo | Ukwahlula, igunya lokuziphatha, imvume yokusebenza kwakhona, kunye neerekhodi zentsingiselo. | Ngubani onokuvuma ukutenxa, kwaye ngaba umthengi uyaziswa? |
| Guqula ulawulo | Imbali yohlaziyo, uvavanyo lwempembelelo, ukuqinisekiswa, ukuqinisekiswa, kunye nesaziso somthengi. | Loluphi utshintsho olufuna imvume yomthengi ebhaliweyo? |
| Ukulandeleka | Iqashiso okanye iirekhodi zeenombolo zothotho, umhambi, iilebhile, ukupakishwa, kunye nobungqina bokukhulula. | Ngaba enye iqashiso egqityiweyo inokulandelwa kumacala omabini? |
| Izikhalazo kunye neCAPA | Iifayile zesikhalazo, iindlela zengcambu, ukuhlolwa kokusebenza kweCAPA, kunye nemithetho yokunyuka. | Zichongwa kwaye zithintelwe njani iintsilelo eziqhubekayo? |
Indlela yokuqinisekisa iisampulu zesixhobo sotyando
Isampulu epolishiwe ayanelanga. Yenza isicwangciso esibhaliweyo sokuvunywa kwesampulu esibonisa ukusetyenziswa okujoliswe kuko kwesixhobo kunye nomngcipheko. Umenzi kunye nomthengi kufuneka bavumelane ngemizobo, inqanaba lohlaziyo, iindlela zovavanyo, indlela yokwamkelwa, ubungakanani besampulu, kunye nendlela iisampulu ezivunyiweyo zibe ziinkosi zemveliso.
- Isazisi: imodeli, uhlaziyo lomzobo, icala, ubungakanani, amanqaku, iqashiso, kunye nokupakishwa koqwalaselo.
- Imilinganiselo kunye nojongano: imilinganiselo ebalulekileyo, iindawo zokukhwelana, ukufakelwa okanye ukuhambelana kwe-screw, ukuphuma, ukulungelelaniswa, kunye nokunyamezela.
- Izinto eziphathekayo kunye nokugqiba: ibakala, ubulukhuni, imeko yomgangatho ophezulu, ukuxhathisa ukubola apho kufanelekileyo, ukugqithisa, ukugubungela, kunye nokucoceka.
- Umsebenzi: ukubamba, ukubandakanyeka kwe-ratchet, ukusika okanye ukugrumba, ukuhanjiswa kwetorque, ukutshixa, ukukhulula, kunye nokunxiba.
- Ukulungiswa kwakhona: ukuchasana nokucocwa okucetywayo kunye nemijikelo yokuvala inzala, kubandakanywa amalungu, i-lumens, iimpawu, iingubo kunye nezibambo.
- Ukupakishwa kunye nokuleyibheli: ukubala, ukukhuselwa, ukuchongwa, imiyalelo, ulwimi, i-UDI okanye idatha yedatha apho kufanelekileyo, kunye nokomelela kwezothutho.
Ukukhangela ukuphindaphinda: emva kokuba isampuli yegolide ivunyiwe, hlola iisampuli ukusuka kwiqashiso lokuqala lokuvelisa usebenzisa imilinganiselo efanayo. Oku kunceda ukumisela ukuba ngaba umenzi angaphinda avelise uyilo oluvunyiweyo kwisikali.
Ukuvavanya i-OEM kunye neSiko leSixhobo sokukwazi
Ukwenza ngokwezifiso kunokuthetha ilogo kwitreyi esele ikhona, isiphatho esilungisiweyo, isixhobo esizinikeleyo sofakelo, okanye isixhobo esitsha ngokupheleleyo. Ezi projekthi azithwali umngcipheko ofanayo wokulawula okanye ubunjineli. Ngaphambi kokwabelana ngemizobo okanye iisampulu, chaza ubumfihlo, ubunini boyilo, ukusetyenziswa okuvunyelweyo kwepropathi enomgangatho ophezulu wokuqonda, ubunini bezixhobo, kunye nokufikelela kwiirekhodi zokuqinisekisa.
Ngeleyibhile yabucala okanye inkqubo yesiko, jonga kwakhona umvelisi izakhono zamathambo OEM / ODM kwaye ubuze ukuba ngubani ophethe umsebenzi ngamnye wolawulo loyilo. Umniki-nkonzo onobuchule kufuneka aguqulele iimfuno zomsebenzisi kwiinkcukacha ezilawulwayo kunye notshintsho lwamaxwebhu-ungathembeli kwimiyalezo engekho sikweni okanye isampuli engavunywanga.
| Inqanaba lokwenziwa ngokwezifiso | Umda wobume | Ubuncinci bolawulo olufunekayo |
|---|---|---|
| Ukuphawula | Ilogo, iilebhile, ikhathoni, imizobo yetreyi, kunye nemiyalelo. | Ukuvunywa komsebenzi wobugcisa, uphononongo lokuleyibhile, ulawulo lohlaziyo, kunye netshekhi yolwimi lwentengiso. |
| Uqwalaselo | Seta ukwakheka, uyilo lwetreyi, ubungakanani, kunye nobungakanani. | Ibhili evunyiweyo yezixhobo, ukuphononongwa kokuhambelana, ukuqinisekiswa kokubala, kunye noluhlu lokupakisha. |
| Ukuguqulwa kwemveliso | Imilinganiselo, isiphatho, ujongano, imathiriyeli, ukugqiba, okanye umsebenzi. | Uvavanyo lomngcipheko, ukuvunywa komzobo, ukuqinisekiswa, ukuqinisekiswa apho kuyimfuneko, kunye nokutshintsha ulawulo. |
| Uphuhliso lwemveliso entsha | Ingcamango entsha okanye inkqubo yesixhobo. | Ulawulo loyilo olusesikweni, ukusetyenziswa kunye nokulawulwa komngcipheko, isicwangciso solawulo, ukuqinisekiswa, ukuqinisekiswa, kunye nokudluliselwa koyilo. |
Ukupakishwa, ukuGcwalisa ukuSeta, kunye nokuNxibelelana koNzala
Iiseti zesixhobo ziyasilela xa isixhobo somntu singekho, singabhalwanga kakuhle, sonakaliswe kuthutho, singahambelani nokufakelwa, okanye kunzima ukusichonga. Funa uluhlu lokupakisha olulawulwayo kunye nenani lokugqibela elihambelana nendawo yetreyi kunye nesichongi sesixhobo. Kwiinkqubo ezinokuthi zisetyenziswe kwakhona, ukuvavanya ukukhutshwa kwamanzi, ukomisa, ukuchithwa, ukufikelela kokucoca, ubunzima, ukukhuselwa kwamacandelo abukhali, kunye nokuhambelana nenkqubo ejoliswe kuyo inzalo.
Xa isikhongozeli esiphinda sisetyenziswe esomeleleyo siyinxalenye yesixokelelwano, jonga kwakhona esesomenzi iinketho zesikhongozeli sokuvala inzala kunye nendlela yokusetyenzwa kwakhona kweziko lezempilo. Isikhongozeli okanye itreyi akufuneki kucingelwe ukuba iyahambelana kuba izixhobo zingena ngokwasemzimbeni kuyo.
Vavanya amandla, ukuhanjiswa, inkonzo, kunye neendleko zizonke
Emva kokuba iimfuno zobugcisa kunye nomgangatho zidibene, thelekisa isicwangciso sorhwebo. Buza umthamo oqhelekileyo kunye nencopho, izithintelo zezinto eziluhlaza, ubungakanani obuncinci bomyalelo, ixesha lokukhokela isampula, ixesha lokukhokela imveliso, imigaqo yokubikezela, ii-Incoterms, amaxwebhu angaphandle, indlela yokupakisha, kunye nenkqubo yokwazisa ukulibaziseka. Phonononga umthengisi imodeli yonikezelo kunye nendawo yokugcina , emva koko uyivavanye ngobungqina obufana nedatha yamva nje yokuhanjiswa kwexesha.
Ixabiso lilonke lobunini libandakanya ngaphezulu kwexabiso leyunithi:
- isiqinisekiso, ubhaliso, uphicotho, uvavanyo, kunye neendleko zokuqinisekisa;
- izixhobo, umsebenzi wobugcisa, ukupakishwa, ukuvala inzalo, imithwalo, imisebenzi, kunye noluhlu lwempahla;
- izixhobo ezilahlekileyo okanye ezonakalisiweyo, ukuthunyelwa kwezinto ngokukhawuleza, kunye nokuphazamiseka kwenkqubo;
- ukulungiswa, iinxalenye ezisecaleni, ukusevisa, ukungabandakanywa kwewaranti, kunye nokuphathwa kwezikhalazo;
- iindleko kunye nomngcipheko wokutshintsha ababoneleli ukuba ngaba ukusebenza kungamkelekanga.
Ngaphambi kokuvunywa, amaxesha okuphendula amaxwebhu, ubunini bezikhalazo, ugunyaziso lokubuyisela, iingxelo zophando, ukulungiswa okanye ukutshintshwa kweendlela, kunye nokunyuka koqhagamshelwano. I-XC Medico ipapasha okwangoku emva kokuthengisa kunye nenkqubo yewaranti yokuphononongwa komthengi.
Umzekelo Ikhadi leSihlomelo soMvelisi weSixhobo sokuSebenza
Faka amanqaku kwikhrayitheriya nganye ukusuka ku-0 ukuya kwisi-5, phindaphinda ngobunzima obucetyiswayo, kwaye urekhode ubungqina obuhlaziyiweyo. Ukuseka amasango okupasa okunyanzelekileyo/okusilela kwiimfuno zomthetho nezolawulo ukuze amanqaku aphezulu orhwebo angakwazi ukuhlawulela ukuthotyelwa kokusilela.
| Indawo yoVavanyo | Ubunzima obucetywayo | kobungqina | Isango lokudlula |
|---|---|---|---|
| Isazisi esisemthethweni kunye nobume bolawulo | 15% | Iinkcukacha zeshishini, ugunyaziso lwemarike, uluhlu lwesixhobo okanye ukukhutshwa njengoko kufanelekile. | Isinyanzelo |
| Inkqubo yolawulo lomgangatho | 15% | ISO 13485 ububanzi / ubume, iziphumo zophicotho, iinkqubo, iirekhodi. | Isinyanzelo |
| Ubuchwephesha kunye namandla okwenza | 20% | Izixhobo, iinkqubo, ukuqinisekiswa, abaqhubi, ulawulo lwenkqubo yangaphandle. | Isinyanzelo kububanzi |
| Umgangatho wesampula kunye nokusebenza | 20% | Ingxelo yokuhlola, uvavanyo olusebenzayo, ukuhambelana, ukuvavanya kwakhona. | Isinyanzelo |
| Ukulandeleka kunye nokulawula utshintsho | 10% | Umkhondo wokulandela umkhondo, uhlaziyo lwamaxwebhu, isivumelwano sesaziso somthengi. | Isinyanzelo |
| Ukuhanjiswa kunye nokuqhubekeka kobonelelo | 10% | Umthamo, ixesha lokukhokela, imbali yokuhanjiswa, isitokhwe sokhuseleko, isicwangciso sokungehla. | Umqobo |
| Inkonzo kunye nenkxaso yendlela yokuphila | 5% | Isikhalazo / inkqubo yeCAPA, iwaranti, ukulungiswa, iindawo ezisecaleni, ukunyuka. | Umqobo |
| Iindleko zizonke kunye nemigaqo yorhwebo | 5% | Iindleko zokufika, i-MOQ, intlawulo, ubunini bezixhobo, ukukhutshwa kwewaranti. | Umqobo |
Gcina i-scorecard egqityiweyo kwifayile yomthengisi, chonga izenzo ezivulekileyo kunye nabanini, kwaye usete ixesha lokuphonononga kwakhona ngokusekelwe kumngcipheko kunye nokusebenza. Ukubeka iliso kwiziphene ezingenayo, izikhalazo, izenzo zokulungisa, ukuhanjiswa, ukuphendula, kunye notshintsho olungagunyaziswanga emva kokuvunywa.
Iiflegi eziBomvu zoMboneleli eziqhelekileyo
Phonononga i-XC Medico's Manufacturing Scope
Ezi zixhobo zangaphakathi zinokuxhasa ukuphononongwa kwesakhono esicwangcisiweyo. Abathengi kusafuneka baqinisekise amaxwebhu kunye nokufaneleka kwemveliso kwimarike yabo kunye nokusetyenziswa okucetywayo.
Imibuzo ebuzwa qho
Sesiphi esona siqinisekiso sibalulekileyo kumenzi wesixhobo sotyando?
Akukho satifikethi siphela sivumela wonke umenzi kunye nemveliso. I-ISO 13485 ngumgangatho obalulekileyo wenkqubo yomgangatho wesixhobo sonyango, kodwa abathengi kufuneka kwakhona baqinisekise iimfuno zolawulo ezingqamene nemveliso kwimarike yendawo ekusingwa kuyo kunye nomda wesatifikethi kunye nokuba semthethweni.
Ngaba ukubhaliswa kwe-FDA kuthetha ukuba isixhobo sotyando sivunyiwe yi-FDA?
Hayi. Ukubhaliswa kokusekwa kwe-FDA kunye noluhlu lwezixhobo akuthethi ukuba indawo okanye isixhobo sivunyiwe, sisusiwe, okanye sigunyazisiwe. Qinisekisa ulwahlulo oluchanekileyo lwesixhobo kunye nendlela esebenzayo yolawulo ye-FDA.
Ngaba umthengi ufanele asoloko eqhuba uphicotho-zincwadi kwisiza somzi-mveliso?
Akunjalo rhoqo. Ubunzulu bophicotho kufuneka busekelwe kumngcipheko. Uphononongo lwamaxwebhu, uvavanyo lwevidiyo ephilayo, iisampulu, kunye nobungqina bomntu wesithathu bunokwanela ekuthengeni okunomngcipheko ophantsi. Umngcipheko ophezulu, unyumba, ulungelelaniswe, ubalulekile, okanye ulungiselelo lonikezelo lwexesha elide lunokuthethelela uphicotho lwendawo.
Zingaphi iisampulu ezifanele ukuvavanywa?
Ubungakanani buxhomekeke kumngcipheko wesixhobo, ukwahluka, indlela yovavanyo, kunye nobungakanani beodolo. Vavanya iiyunithi ezaneleyo zokuvavanya imilinganiselo ebalulekileyo kunye nomsebenzi, emva koko uqinisekise ukuphindaphinda kwakhona usebenzisa indawo yokuqala yemveliso.
Ingaba izixhobo zotyando zingenziwa ngokwezifiso zeleyibhile yabucala?
Ewe, kodwa ukubeka uphawu, ukusetwa kobumbeko, ukuguqulwa kwemveliso, kunye nophuhliso lwemveliso entsha kufuna amanqanaba ahlukeneyo amaxwebhu kunye nolawulo lolawulo. Chaza ubunini boyilo, ukuqinisekiswa, uxanduva lokuleyibheli, ulawulo lotshintsho, kunye nogunyaziso lwentengiso phambi kokuba uqalise.
Ingaba umenzi ovunyiweyo kufuneka avavanywe kangaphi kwakhona?
Misela ikhefu ngokomngcipheko kunye nokusebenza kwangempela. Iziphene, izikhalazo, ukusilela konikezelo, utshintsho olukhulu, utshintsho lwesatifikethi, okanye imiba yokulungisa inokubangela ukuphononongwa kwangaphambili okanye uphicotho.
Ukuqukumbela
Uvavanyo lomenzi olusebenzayo luguqula amabango okuthengisa abe bubungqina obunenjongo. Chaza iimfuno, qinisekisa iinkcukacha zomthetho kunye nolawulo, ukulandelela iqashiso lokwenyani, iisampulu zovavanyo ngokuchasene neendlela ezivunyiweyo, kwaye uvavanye ulawulo olugcina imveliso yexesha elizayo ingaguquki. Ikhadi lamanqaku elibhalwe phantsi lenza izigqibo zababoneleli-nkonzo kube lula ukuzithethelela kwaye libonelela ngesiseko sokuhlolwa komsebenzi okuqhubekayo.
IiReferensi ezigunyazisiweyo
- Umbutho waMazwe ngaMazwe woMgangatho: ISO 13485-Iinkqubo zolawulo lomgangatho wezixhobo zonyango.
- I-US FDA: Ukubhaliswa kwe-FDA ngokuchasene nokuvunywa kwesixhobo, ukukhutshwa, okanye ugunyaziso.
- I-US FDA: Indlela yokufunda kunye nokuthengisa isixhobo sonyango.
- IKhomishini yaseYurophu: Imimiselo yezixhobo zonyango kunye nezibophelelo zomvelisi.
