Sebenzisa lawa masheke ayishumi ukuze uqhathanise abakhiqizi bokufakelwa kwamathambo kuhlelo lokulawula, ukulandeleka, ukulawulwa kwekhwalithi, ukulungela ukukhiqiza, imigomo yezohwebo nokwesekwa kwesikhathi eside—hhayi ngezimangalo zentengo kuphela.
Impendulo esheshayo
Umkhiqizi othembekile wokufakela amathambo kufanele akwazi ukunikeza ubufakazi—hhayi izithembiso kuphela—okuhlanganisa ubunikazi bakhe obusemthethweni, ububanzi bokuphathwa kwekhwalithi, ukugunyazwa kwemakethe okuqondene nomkhiqizo, ukulandeleka kwezinto ezibonakalayo, ukuqinisekiswa kwedizayini nenqubo, umthamo wokukhiqiza, imigomo ye-OEM, izilawuli zokulethwa, ukuphathwa kwezikhalazo kanye nezinkomba ezihambisana nemakethe yakho.
Qala ngamadokhumenti, uwaqinisekise ngokuzimela, hlola ukuthi ifekthri izisebenzisa kanjani izinqubo zayo, futhi ugcwalise i-oda lesampula elilawulwayo ngaphambi kokwenza isibopho sesikhathi eside.
Ukukhetha umenzi wokufakelwa kwamathambo kuyisinqumo sokulawula ubungozi. Ikhotheshini ephansi ingabiza uma ububanzi besitifiketi bungafani nomkhiqizo, amathuluzi angaphelele, ukubhaliswa kokubambezeleka kwemibhalo, noma ukugcwaliswa kabusha kungathembeki. Ngesikhathi esifanayo, iwebhusayithi ephucuziwe noma ikhathalogi ende yomkhiqizo ayifaki ubufakazi bokuthi umkhiqizi angakwazi ukuhlangabezana nezidingo zemakethe yakho eqondiwe.
Lo mhlahlandlela uklanyelwe abasabalalisi bama-orthopaedic bamazwe ngamazwe, abangenisa kwamanye amazwe, amathimba okuthenga ezibhedlela kanye nabathengi bamalebula azimele. Igxila emibuzweni nasebufakazini obudingekayo ngaphambi kokugunyazwa komphakeli. Ayithathi indawo yokubuyekezwa kokulawula, ukuhlolwa kwekhwalithi, ukubuyekezwa kwezomthetho noma ukuhlolwa komtholampilo.
Amadokhumenti okufanele uwacele ngaphambi kokuqhathanisa izingcaphuno
Buza wonke umkhiqizi osohlwini olufushane ngephakheji yobufakazi efanayo. Isicelo esivamile senza ukuqhathanisa kube lula futhi sinciphise ingozi yokukhetha inkampani ngoba inikeze izinto zokuthengisa ezikhangayo—kodwa ezingaphelele.
| Buyekeza indawo | Ubufakazi bokucela | Okufanele uqinisekise | uphawu olujwayelekile lwesixwayiso |
|---|---|---|---|
| Ubunikazi benkampani | Ilayisense yebhizinisi, ikheli lemboni kanye nemininingwane yomkhiqizi osemthethweni | Iqembu lenkontileka, umenzi kanye nomphathi wesitifiketi baxhumeke ngokucacile | Inkampani yokuhweba yethulwa njengomkhiqizi osemthethweni ngaphandle kwencazelo |
| Uhlelo lwekhwalithi | Isitifiketi samanje se-ISO 13485 kanye nobubanzi | Umkhiphi, ukufaneleka, ikheli, imisebenzi kanye nezigaba zomkhiqizo ezimboziwe | Isitifiketi siphelelwe yisikhathi noma indawo yaso ayifaki imikhiqizo eceliwe |
| Ukufinyelela emakethe | Ukubhaliswa okuqondene nomkhiqizo othile, ukuvunyelwa, izitifiketi noma izimemezelo | Amagama amamodeli, imakethe ehlosiwe, inombolo yesitifiketi kanye nesimo samanje | Ukubhaliswa kwenkampani kuchazwa njengokugunyazwa kwawo wonke umkhiqizo |
| Ukulandeleka | Isitifiketi sempahla eyisampula, irekhodi lenkatho, umhambi kanye nerekhodi lokuhlola | Amarekhodi axhuma izinto ezingavuthiwe, indawo yokukhiqiza kanye nomkhiqizo oqediwe | Ukucaciswa kwezinto ezijwayelekile kuphela okutholakalayo |
| Ukuqinisekisa | Idizayini esebenzayo, ubufakazi bemishini, inqubo, yokuhlanza kanye nokupakisha | Ubufakazi busebenza kumodeli nokucushwa okuceliwe | Izifinyezo zokuhlola zishiya izinombolo zemodeli, izindlela noma imibandela yokwamukela |
| Ukunikezela ukusebenza | Isitatimende sekhono, izikhathi zokuhola ezijwayelekile kanye nedatha yokulethwa kwakamuva | Isikhathi sokuhola esicashuniwe sibonisa umthamo wangempela nokutholakala kwempahla | Lonke i-oda lichazwa njengelikwazi ukuphuthuma ngaphandle kokusekela idatha |
| Ukulawula emva kokuthengisa | Isikhalazo, i-CAPA, ukuqapha kanye nezinqubo zokukhumbula | Izibopho nezikhathi zokukhuphuka zichaziwe | Ayikho inqubo ebhaliwe ekhona ngemva kokuthunyelwa |
1Qinisekisa ubunikazi benkampani obusemthethweni kanye nendima yokukhiqiza
Okokuqala nquma ukuthi ubani ozokhiqiza izigxivizo, umnikazi womklamo nokubhaliswa, ubani ozovela kulebula, nokuthi ubani ozosayina inkontileka. 'Umphakeli,' 'imboni,' 'umnikazi womkhiqizo' kanye 'nomkhiqizi osemthethweni' akuzona ngokuzenzakalela izinto ezifanayo.
Qhathanisa igama lenkampani nekheli elikhonjiswe kulayisensi yebhizinisi, isitifiketi sesistimu yekhwalithi, imibhalo yomkhiqizo, ikhotheshini, umsebenzi wobuciko ngelebula kanye ne-akhawunti yasebhange. Uma izinhlangano ezahlukene zihilelekile, cela incazelo ebhaliwe yendima yazo nobudlelwano benkontileka.
- Qinisekisa ikheli lendawo yokukhiqiza, hhayi ikheli lehhovisi lokuthengisa kuphela.
- Buza ukuthi yiziphi izinqubo ezenziwa ngaphakathi endlini nokuthi yiziphi ezinikezwa ngaphandle.
- Qinisekisa ukuthi ubani olawula izinguquko zedizayini, amafayela obuchwepheshe nophenyo lwezikhalazo.
- Kumaphrojekthi anelebula yangasese, khomba ukuthi iyiphi inhlangano ezobamba ukubhaliswa emakethe ngayinye.
2Qinisekisa ububanzi besistimu yekhwalithi kanye nokugunyazwa kwemakethe okuqondene nomkhiqizo
I-ISO 13485 iyindinganiso yokuphatha ikhwalithi yedivayisi yezokwelapha, kodwa isitifiketi kufanele sibuyekezwe ngokomongo. Hlola ibhizinisi elisemthethweni, ikheli lesayithi, imisebenzi ekhaviwe, izigaba zomkhiqizo, izinsuku zokukhishwa nokuphelelwa yisikhathi, kanye nesimo senhlangano enikeza izitifiketi. Isitifiketi esivumelekile siyisiqalo esibalulekile; ayithathi indawo yobufakazi obuqondene nomkhiqizo.
E-United States, ungamukeli 'i-FDA ebhalisiwe' noma 'i-FDA eqinisekisiwe' njengobufakazi bokuthi idivayisi isuliwe noma igunyaziwe. I-FDA ithi ukubhaliswa kwesikhungo nokufakwa kuhlu kwamadivayisi akusho ukugunyazwa, ukugunyazwa noma ukugunyazwa. Cela ukuhlukaniswa komkhiqizo okusebenzayo kanye nolwazi lokulethwa kwemakethe, lapho kudingeka khona, futhi ukuqinisekise kusizindalwazi esifanelekile se-FDA.
Nge-European Union, buyekeza indima yomkhiqizi ngaphansi koMthethonqubo (EU) 2017/745, umzila wokuhlola ukuhambisana osebenzayo, isimemezelo sokuvumelana kanye nobubanzi besitifiketi. Lapho kufanele khona, qinisekisa ulwazi lwemizimba eyazisiwe kanye nesitifiketi ngezinsiza ezisemthethweni zase-Europe ezifana ne-EUDAMED.
Ungamvumeli umphakeli ngokusekelwe kumalogo
Amalogo e-ISO, CE kanye ne-FDA encwajaneni awabona ubufakazi obanele. Rekhoda isitifiketi esiqondile noma inombolo yokuthunyelwa, ibhizinisi elisemthethweni elikhavwe, umndeni womkhiqizo, imodeli kanye nemakethe eqondiwe, bese uqinisekisa into ngayinye ngokuzimela.
Izibonelo zemibhalo yesitifiketi enikezwe i-XC Medico
Izithombe ezingezansi ziyizibonelo zemibhalo ukuze zibuyekezwe okokuqala. Ngaphambi kwemvume yomphakeli, cela amakhophi amanje anokulungiswa okugcwele futhi uqinisekise ibhizinisi elisemthethweni, indawo yokukhiqiza, inombolo yesitifiketi, indikimba ekhiphayo, izinsuku zokuqinisekisa, imisebenzi ekhaviwe kanye nobubanzi bomkhiqizo obusebenzayo.
Isibonelo sombhalo wesitifiketi se-TÜV SÜD CE
Isibonelo sedokhumenti yesitifiketi se-TÜV SÜD ISO 13485
Isibonelo sedokhumenti ye-Spine FSC
Isibonelo sedokhumenti yesitifiketi se-ISO 13485
Izithombe zedokhumenti ziboniswa ukuze zisetshenziswe kuphela futhi akufanele zithathwe njengobufakazi bokuthi yonke imikhiqizo igunyaziwe kuzo zonke izimakethe.
3Buyekeza izinto ezingavuthiwe kanye nokulandeleka kokukhiqiza
Ukuthengwa kwe-orthopedic implant kudinga okungaphezu kokuqinisekisa ibanga lezinto ezibonakalayo kukhathalogi. Cela umenzi ukuthi akhombise ukuthi isifakelo esiqediwe singalandelelwa kanjani ngomshini, ukwelashwa ngokushisa noma ukwelashwa kwendawo, ukuhlolwa namarekhodi angenayo ezinto ezingavuthiwe.
Isampula ewusizo yokulandeleka kufanele ixhume inkatho yomkhiqizo oqediwe noma isihlonzi se-serial nesitifiketi sempahla engavuthiwe, isihambi sokukhiqiza, amarekhodi enqubo ebalulekile kanye nokuhlolwa kokugcina. Izivivinyo eziqondile namazinga ancike kudivayisi, impahla, ukusetshenziswa okuhlosiwe kanye nemakethe; gwema ukusebenzisa uhlu lokuhlola olujwayelekile kuwo wonke umndeni ofakiwe.
- Cela irekhodi leqoqo lesampula elilungisiwe lomkhiqizo ofanayo.
- Hlola ukuthi izinto ezingavumelani zihlonzwa, zihlukaniswa futhi zihlukaniswa kanjani.
- Buza ukuthi izinqubo ezikhethekile ezinikezwa ngaphandle zihlala zilandeleka kanjani.
- Qinisekisa ukuthi amarekhodi ekhwalithi agcinwa isikhathi esingakanani emakethe efanele.
I-XC Medico yomphakathi Ukubuka konke kokulawulwa kwekhwalithi kwe-orthopedic implant kungasetshenziswa njengesiqalo sengxoxo, kodwa umthengi kusafanele acele umkhiqizo- kanye nobufakazi obuningi obuqondile ngesikhathi sokufaneleka.
4Hlola ukuqinisekiswa komklamo, ukuqinisekiswa kwenqubo nokuhlola
Buza ukuthi ibuphi ubufakazi obusekela isistimu yokufakelwa ohlela ukuyithenga. Umbiko wokuhlola wosayizi ohlukile, impahla noma ukucushwa kungase kungameleli. Umkhiqizi kufanele akwazi ukuchaza ukuthi ukulungiselelwa okuhloliwe kukhethwe kanjani nokuthi imiphumela isebenza kanjani kuwo wonke umndeni womkhiqizo.
Ngokuya ngomkhiqizo, ukubuyekezwa kungabandakanya okokufaka kwedizayini, ukuphathwa kobungozi, ukuhlolwa kobukhulu, ukuhlolwa komshini, ukuhambelana kwe-biocompatibility, ukuhlanza, ukupakisha, ukuvala inzalo noma ukuqinisekiswa kwenqubo ekhethekile. Ikhwalithi yakho kanye namathimba okulawula kufanele achaze ukuthi imaphi amarekhodi adingekayo emakethe eqondiwe kanye nokusetshenziswa okuhlosiwe.
Ngesikhathi sokubuyekezwa kwefekthri, qhathanisa izinqubo ezibhaliwe nokukhiqizwa kwangempela. I-XC Medico inikeza umbono wayo womphakathi inqubo yokukhiqiza i-orthopedic implant ; abasabalalisi kufanele basebenzise ulwazi olunjalo ukuze balungiselele imibuzo yocwaningomabhuku eqondile kakhulu kunokuphatha incazelo yewebhusayithi njengobufakazi bocwaningo.
5Hlola iphothifoliyo yomkhiqizo, amathuluzi kanye nokuphelela kwesistimu
Ikhathalogi ebanzi iwusizo kuphela uma izinhlelo ezidingwa amakhasimende akho seziphelele, zibhalwe ngokungaguquki futhi zitholakala ngokwangempela. Buyekeza izimila, izinsimbi, amathreyi, amakesi, izingxenye eziyisipele, ububanzi bosayizi nezinto zokugcwalisa njengesistimu eyodwa.
- Qinisekisa ukuthi yimaphi ama-SKU ajwayelekile, enzelwe uku-oda noma aqedwe.
- Hlola ukuthi amathuluzi nokwehluka kokufakelwa kuyafana yini nesistimu ebhaliwe efanayo.
- Buyekeza ukulebula, imiyalelo yokusetshenziswa kanye nokumiswa kokupakishwa yimakethe.
- Buza ukuthi izinguquko zedizayini kanye nezingxenye ezingaqhubeki zidluliselwa kanjani.
- Qinisekisa ukuthi izitatimende zokusebenzisana zibhaliwe futhi zikhawulelwe kuzinhlanganisela eziqinisekisiwe.
Ungazamukeli izitatimende ezibanzi njengokuthi 'ihambisana nawo wonke amasistimu' noma 'i-MRI ephephile' ngaphandle kwamalebula aqondene nedivayisi kanye nobufakazi obusekelayo. Ukuhambisana kanye nolwazi lokuphepha lwe-MR kufanele kuhlolwe ngomkhiqizo kanye nezimo ezihlosiwe.
6Hlola umthamo wokukhiqiza, i-inventory kanye nezilawuli zokulethwa
Amandla kufanele ahlolwe kuqhathaniswa nesibikezelo sakho, hhayi njengenombolo yefekthri ezimele. Yabelana ngengxube engokoqobo ye-SKU, imvamisa yoku-oda, ishejuli yethenda kanye nezinga lesevisi eliqondiwe. Bese ucela umkhiqizi ukuthi achaze umthamo otholakalayo, izinqubo zebhodlela, inqubomgomo yokusungula kanye nokuqagela kwesikhathi sokuhola.
Buyekeza umehluko phakathi kwemikhiqizo esesitokweni, ukukhiqizwa okujwayelekile nezinto ezenziwe ngokwezifiso. Buza ukuthi ukushoda kwezinto ezingavuthiwe, izinqubo eziphuma ngaphandle, ukunakekelwa kwemishini kanye neziqongo zesidingo kulawulwa kanjani. Idatha yakamuva yokulethwa ngesikhathi yama-oda aqhathanisekayo iwusizo kakhulu kunesithembiso esivamile sokuthunyelwa ngokushesha.
I-XC Medico i-implant supply-chain kanye ne-warehousing uhlolojikelele luchaza ukuma kwayo kwenqubo yomphakathi. Umsabalalisi kufanele alandele isifinyezo samanje sokutholakala kanye nezikhathi zokuhola ezibhaliwe zamasistimu okuyiwona acutshungulwayo.
7Cacisa i-OEM/ODM, i-MOQ kanye nemibandela yendawo yobuhlakani
Ilebula yangasese namaphrojekthi enziwe ngendlela oyifisayo adinga izinqumo ezingakhaviwe ngentengo yeyunithi. Ngaphambi kokugunyaza amasampula, bhala ukuthi ubani umnikazi wemidwebo, amathuluzi, idatha yokuqinisekisa, umsebenzi wobuciko opakishwayo kanye nokubhaliswa okuwumphumela. Chaza ukuthi ulwazi oluyimfihlo luvikelwe kanjani nokuthi amadizayini anganikezwa yini amanye amakhasimende.
- Hlukanisa ukulebula okujwayelekile okuyimfihlo kusukela ekwenzeni ngokwezifiso umklamo wangempela.
- Chaza isampula, izigaba zokuqinisekisa kanye nokugunyazwa kokukhiqiza.
- Rekhoda inani elincane le-oda nge-SKU nangesistimu ephelele.
- Vumelana ngesaziso sokushintshwa komklamo kanye nezibopho zokuqinisekisa kabusha.
- Cacisa ubunikazi bamathuluzi, imigomo yendawo namalungelo okunqanyulwa.
Ukuze uthole ukubuyekezwa okujulile kwezohwebo, sebenzisa lokhu Uhlu lokuhlola okufanele umkhiqizi we-OEM oluhambisana nekhwalithi yakho nokuhlola okusemthethweni.
8Hlola ukubhaliswa, ithenda kanye nokusekelwa kwemibhalo yobuchwepheshe
Umkhiqizi angase akhiqize imikhiqizo eyamukelekayo futhi aqhubeke engalingani kahle uma imibhalo yakhe ingakusekeli ukubhaliswa noma amathenda emakethe yakho. Dala i-matrix yedokhumenti ngaphambi kokufaka i-oda lokuqala lezentengiso.
I-matrix kufanele ihlonze idokhumenti ngayinye edingekayo, umnikazi, ulimi, ifomethi, ukubuyekezwa, usuku olulindelekile lokulethwa kanye nesimo sobumfihlo. Buyekeza ukuthi umkhiqizi ulawula kanjani ukubuyekezwa uma isitifiketi, ilebula, imiyalelo, imininingwane noma idizayini ishintsha.
Cela iphekhi yedokhumenti eqondene nemakethe
Esikhundleni sokubuza ukuthi, 'Ingabe unayo i-CE noma i-FDA?', hlinzeka ngezwe okuqondiwe kulo, umndeni womkhiqizo nohlu lwamamodeli. Cela umkhiqizi ukuthi enze imephu ye-SKU ngayinye ebufakazini obutholakalayo bokulawula nobuchwepheshe. Iba nezisebenzi zokulawula eziqeqeshiwe eziqinisekisa ukuthi imibhalo yanele imakethe oyihlosile.
9Buyekeza ukuphathwa kwezikhalazo, i-CAPA kanye nokulungela ukukhumbula
Ukufaneleka komphakeli kufanele kufake okwenzekayo ngemva kokuthunyelwa. Buza ukuthi izikhalazo zitholwa, zihlolwa, ziphenywa kanjani, zithrenda kanjani futhi zivalwe kanjani. Qinisekisa ukuthi umkhiqizi uxhumana kanjani nemicimbi okungenzeka ibikeke, izenzo zenkambu, ukukhumbula kanye nezenzo zokulungisa kubasabalalisi nabanye opharetha bezomnotho.
- Ubani oyisikhalazo esiyinhloko nokuxhumana naye ngokuqapha?
- Iluphi ulwazi oludingekayo ukuze kuqalwe uphenyo?
- Ilawulwa futhi ihlolwe kanjani imikhiqizo?
- Ibhalwe kanjani imbangela, i-CAPA kanye nokuhlolwa kokusebenza ngempumelelo?
- Ngabe inkatho ethintekile namakhasimende akhonjwa kanjani ngesikhathi sesenzo senkambu?
Unganciki 'kokwesekwa ngokobuchwepheshe' okungakahleleki njengengxenye yezinqubo ezibhalwe phansi zangemuva kwemakethe kanye nezibopho zokulawula ezabiwe ngokucacile.
10Qalisa i-oda lesampula elilawulwayo kanye nekhadi lesikolo lomhlinzeki
I-oda lesampula lihlola ngaphezu kokubukeka komkhiqizo. Yisebenzise ukuze uhlole ukunemba kwengcaphuno, ukulawulwa kwemibhalo, ukulebula, ukupakisha, ukuxhumana, isikhathi sokuhola, imiphumela yokuhlolwa kanye nokuphendula imibuzo. Rekhoda imibandela yokwamukela ngaphambi kokuba isampula iyalwe.
Thola umkhiqizi ngamunye usebenzisa imibandela enesisindo efanayo. Ikhadi lamaphuzu elijwayelekile lingabandakanya ukulingana okulawulwayo, ubufakazi bekhwalithi, ukulandeleka, amandla obuchwepheshe, ukuphelela kwesistimu, ukwethembeka kokunikezwayo, imibhalo, imigomo yezohwebo nokusekelwa. Phatha intengo njengento eyodwa esikhundleni sesici eseqile.
| Isigaba | Isisindo esiphakanyisiwe | Isibonelo sombuzo wokushaya amagoli |
|---|---|---|
| Ukulingana kwesistimu nekhwalithi | 25% | Ingabe ubufakazi obuqinisekisiwe buhlanganisa ibhizinisi elisemthethweni, isiza, umkhiqizo kanye nemakethe eqondiwe? |
| Ukulandeleka nokuqinisekisa | 20% | Ingabe umphakeli angaxhuma izimangalo zomkhiqizo kumarekhodi alawulwayo? |
| Ukuphelela komkhiqizo nokokusebenza | 15% | Ingabe uhlelo oludingekayo luphelele, lubhaliwe futhi luyasekelwa? |
| Amandla nokulethwa | 15% | Ingabe amandla, i-inventory kanye nezimangalo zesikhathi sokuhola zisekelwa idatha yamanje? |
| Amadokhumenti nokusekelwa kwangemva kwemakethe | 15% | Ingabe umphakeli angakweseka ukubhaliswa, amathenda, izikhalazo kanye nokulawula ushintsho? |
| Ukulingana kwezohwebo | 10% | Ingabe intengo, i-MOQ, inkokhelo, i-IP kanye nemibandela yendawo iyasimama? |
Lungisa izisindo zemakethe yakho kanye nobungozi bomkhiqizo. Noma yikuphi ukwehluleka okubalulekile kokulawula, ikhwalithi noma ukulandeleka kufanele kuthathwe njengesango, kunganxeshezelwa ngentengo ephansi noma amaphuzu aphezulu kwenye indawo.
Amafulegi abomvu ajwayelekile lapho ukhetha umkhiqizi wokufakelwa
Izimangalo ngaphandle kobubanzi
Umkhiqizi uthi 'i-FDA, i-CE ne-ISO iqinisekisiwe' kodwa akakwazi ukuxhuma isimangalo ebhizinisini elisemthethweni, umkhiqizo, imodeli kanye nemakethe.
Amadokhumenti angakwazi ukuqinisekiswa
Izinombolo zesitifiketi, izindikimba ezikhiphayo, amadethi noma imikhiqizo ekhaviwe azikho, azihambisani noma azitholakali ukuze kuqinisekiswe okuzimele.
Inani ngaphambi kwezidingo
Ikhotheshini eqinile inikezwa ngaphambi kokuba umenzi aqinisekise ukumiswa komkhiqizo, ukupakishwa, imibhalo kanye nezidingo zokubhalisa.
Imibiko yokuhlola ejwayelekile
Imibiko ayihlonzi imodeli ehloliwe, ukucushwa, indlela, indlela yokwamukela noma ukuxhumana nomkhiqizo oceliwe.
Ubunikazi bomkhiqizi obungacacile
Amagama enkontileka, isitifiketi, ilebula, i-invoyisi ne-akhawunti yasebhange ayahluka ngaphandle kwencazelo ebhaliwe.
Ayikho inqubo ye-post-market
Ukusekelwa kuncike koxhumana nabo ngabanye abadayisi esikhundleni sesikhalazo esibhaliwe, i-CAPA, ukuqapha kanye nezinqubo zokukhumbula.
Ungaqhathanisa kanjani i-XC Medico nabanye abakhiqizi
Sebenzisa uhlu lokuhlola olufanayo ku-XC Medico kanye nabo bonke abanye abakhiqizi abasohlwini olufushane. Ifekthri esesidlangalaleni, amakhasi okulawula ikhwalithi kanye namakhasi e-supply chain angakusiza ukuthi ulungiselele imibuzo, kodwa ukugunyazwa kwabahlinzeki kufanele kusekelwe kumadokhumenti amanje kanye nobufakazi obuhambisana nemikhiqizo nemakethe yakho.
Isinyathelo esilandelayo esisebenzayo ukulungisa uhlu lwakho lwezwe okuqondiwe, amasistimu omkhiqizo adingekayo, iphethini ye-oda elilinganiselwe, izimfuneko ze-OEM kanye ne-matrix yedokhumenti. Cela umenzi ngamunye ukuthi aphendule ngendlela efanayo. Lokhu kukhiqiza irekhodi eliqhathanisekayo lekhwalithi, ukulawulwa kanye nokubuyekezwa kwezohwebo.
Uhlolojikelele lwenkampani ye-XC Medico kanye nokukhiqiza. Sebenzisa ividiyo ukuze ulungiselele imibuzo ezolandela; ukugunyazwa okuphelele komphakeli kusetshenziswa imibhalo yamanje elawulwayo kanye nobufakazi bokucwaninga.
Uma inhlangano yakho ingena esikhundleni somhlinzeki okhona, futhi buyekeza ubungozi bokusebenza obuchazwe kumhlahlandlela wokuthi ukushintsha abahlinzeki be-orthopedic implant ngaphandle kokuphazamisa ukusatshalaliswa.
Imibuzo ejwayelekile ukubuzwa
Yiziphi izitifiketi okufanele umenzi wokufakelwa kwamathambo abe nazo?
Impendulo incike kumkhiqizo kanye nemakethe eqondiwe. I-ISO 13485 iyindinganiso eyaziwa kabanzi yokuphatha ikhwalithi yezinhlangano zamadivayisi ezokwelapha, kodwa abathengi kufanele babuyekeze ubufakazi bokulawula obuqondene nomkhiqizo othize. Qinisekisa ububanzi besitifiketi, isayithi, ibhizinisi elisemthethweni, umndeni womkhiqizo, isimo samanje kanye nezimfuneko zemakethe ezisebenzayo.
Ingabe ukubhaliswa kwe-FDA kusho ukuthi isimila sivunyelwe?
Cha. I-FDA ithi ukubhaliswa kwesikhungo nokufakwa kuhlu kwedivayisi akusho ukugunyazwa, ukugunyazwa noma ukugunyazwa kokusungulwa noma amadivayisi akho. Lapho idivayisi idinga ukubuyekezwa kwemakethe, qinisekisa imvume esebenzayo, ukugunyazwa noma okunye ukugunyazwa ngokuhlukile.
Umsabalalisi angasiqinisekisa kanjani isitifiketi se-ISO 13485?
Buyekeza inombolo yesitifiketi, inhlangano esemthethweni, ikheli lesayithi, imisebenzi ekhaviwe, ububanzi bomkhiqizo, indikimba yokunikeza izitifiketi nezinsuku zokuqinisekisa. Qinisekisa isitifiketi nenhlangano ekhiphayo noma enikeza izitifiketi lapho kungenzeka khona, futhi uqinisekise ukuthi isistimu yekhwalithi isetshenziswa ngesikhathi sokubuyekezwa kwedokhumenti noma ukuhlolwa.
Yimaphi amadokhumenti okufanele ahlolwe ngaphambi kokufaka i-oda?
Ubufakazi obujwayelekile buhlanganisa imininingwane yenkampani neyendawo yokukhiqiza, ububanzi be-ISO 13485, imibhalo yemakethe eqondene nomkhiqizo, amasampula okulandeleka okubalulekile kanye nenqwaba, ukuqinisekiswa okusebenzayo noma ubufakazi bokuhlola, ukulebula, imiyalelo, imigomo yokunikezela, izinqubo zezikhalazo kanye nezibopho zokulawula ushintsho. Uhlu oluqondile kufanele lubekwe ngabasebenzi abaqeqeshiwe bekhwalithi kanye nabaphathi.
Uyini umehluko phakathi komkhiqizi wokufakelwa kanye nomphakeli?
Umkhiqizi wenza noma ulawule imisebenzi yokukhiqiza futhi angase futhi abambe izibopho zokuklama nokulawula. Umphakeli angaba ngumkhiqizi, umnikazi womkhiqizo, umsabalalisi noma inkampani yokuhweba. Abathengi kufanele bakhombe indima ebhalwe phansi yebhizinisi ngalinye esikhundleni sokuthembela encazelweni yezentengiso kuphela.
Ingabe intengo kufanele ibe umbandela oyinhloko lapho ukhetha umkhiqizi?
Cha. Intengo kufanele ihlolwe kanye nokulingana okulawulwayo, ubufakazi bekhwalithi, ukulandeleka, ukuphelela komkhiqizo, umthamo, ukwethembeka kokulethwa, imibhalo, ukwesekwa kwangemuva kwemakethe kanye nemibandela yenkontileka. Intengo yokuqala ephansi ingase idale ukubhaliswa okukhulu, uhlu lwempahla noma izindleko zekhwalithi kamuva.
Cela iphekhi yokuqinisekisa yomkhiqizi
Yabelana ngemakethe yakho ohlosiwe, isigaba somkhiqizo, iphethini ye-oda elindelwe kanye nezidingo ze-OEM. Cela iphakethe ledokhumenti ukuthi ithimba lakho lekhwalithi, elilawulayo kanye nokuthengwa kwempahla lingabuyekezwa ngaphambi kokuthuthela kumasampula noma i-oda lezentengiso.
Xhumana ne-XC MedicoIzinkomba zokulawula ezisemthethweni
- I-TS EN ISO 13485:2016 Izinhlelo zokuphatha ikhwalithi yemishini yezokwelapha
- I-US FDA - I-Quality Management System Regulation
- I-US FDA - Ukubhaliswa kwe-FDA, isitifiketi, imvume kanye nokuvunyelwa kuchaziwe
- I-European Commission - Abasebenzi bezomnotho bedivayisi yezokwelapha
- I-European Commission - Ukubuka konke kwe-EUDAMED
Isaziso sokusetshenziswa kochwepheshe: Lesi sihloko sihloselwe ukusekela ukukhuthala okufanele komnikezeli webhizinisi kuya kwebhizinisi. Akusona iseluleko somtholampilo, iseluleko sezomthetho noma isinqumo sokuthi noma yimuphi umkhiqizo othile ugunyazwe emakethe ethile. Izidingo zokulawula nekhwalithi ziyahlukahluka ngokuya ngedivayisi, ukusetshenziswa okuhlosiwe kanye negunya lokulawula; thintana nochwepheshe abaqeqeshiwe ngaphambi kokwenza izinqumo zokugunyaza noma zokuthenga.
