Indlela yokufumana aBaboneleli be-Orthopedic abaSebenzayo ngeendleko ngaphandle kokuthomalalisa umgangatho

Ukukhangela kwihlabathi jikelele kunokuthoba ngokupheleleyo iindleko zakho zokufakelwa. Kodwa kubasasazi, umsebenzi wokwenyani 'akufumani oyena mboneleli unexabiso eliphantsi.' Lixabiso eliphantsi lilonke elifunyenweyo ngelixa ugcina amaxesha akho obhaliso, ukwamkelwa esibhedlele, kunye nomngcipheko wokhuseleko lwesigulana phantsi kolawulo..

Apha ngezantsi kukho isakhelo esisebenzayo, esiphindaphindwayo onokusisebenzisa ukuze uvumele ababoneleli ngamathambo abangabizi kakhulu-ngaphandle kokufunda kabuhlungu ngolibaziseko lwethenda, ukubuyisela, okanye isenzo esithintelwayo sangaphandle.

I-Key Takeaway : Ixabiso leyunithi eliphantsi alinantsingiselo ukuba umthengisi akakwazi ukubonisa ukulandeleka, ukulungela uphicotho, kunye nolawulo lwenguquko olulawulwayo.

Izinto eziphambili ezithathwayo

• Qhuba isiqinisekiso somthengisi njengeprojekthi yomngcipheko, hayi uthethathethwano ngexabiso. Qala ngezinto ezingaxoxisiyo, emva koko ufake amanqaku ababoneleli ngerubrikhi ebhaliweyo.

• Qinisekisa umda wesatifikethi, hayi iilogo kuphela. Buza ii-PDF zesatifikethi, iidilesi zesayithi eziphicothiweyo, kunye neengxelo zomda ezihambelana nokufakelwa.

• Funa 'ipakethe yamaxwebhu' kwangethuba. Sesona sihluzo esikhawulezayo sokuvuthwa-kwaye sikugcina iinyanga ngexesha lobhaliso kunye neethenda.

• Phicotha iinkqubo ezenza iindleko ezifihlakeleyo. Amaxesha okuphendula kweCAPA, ukuqinisekiswa kwenkqubo ekhethekileyo, kunye nomba wolawulo lotshintsho ngaphezu kwencwadana epolishiwe.

• Phatha umgangatho njengento eqhubekayo. Tshixa uxanduva kwiSivumelwano soMgangatho kwaye ubeke iliso ekusebenzeni ngamakhadi amanqaku.

Kutheni 'ezitshiphu' abaxhasi bebiza ngokukhawuleza

Abasasazi bakholisa ukuva intlungu yomboneleli ombi kwiindawo ezintathu:

1. Ubhaliso kunye nokulibaziseka kwethenda (amaxwebhu obugcisa alahlekileyo okanye abuthathaka).

2. Ukungazinzi konikezelo (amaxesha okukhokela alula xa imfuno inyuka).

3. Iziganeko ezisemgangathweni (izikhalazo, ukulungiswa kwakhona, ukubuyiswa, uphando, kunye nexesha langaphakathi lokucwina eliza kunye nabo).

Ke xa uthelekisa iikowuti, ungayeki kwixabiso leyunithi. Yakha uvavanyo lwakho malunga neendleko oza kuzihlawula ngokwenene:

• Ixesha loxwebhu (iqela lakho + abacebisi bolawulo lwasekhaya)

• Ukuhanjiswa kunye nokwahluka kwamasiko

• Umngcipheko woluhlu lwempahla (ukungalingani komthwalo, abahambi kancinci, baphelelwa lixesha)

• Ukuphathwa kwesiganeko esisemgangathweni (izikhalazo, ukulandelwa kweCAPA, ukubuyisela izinto)

• Impembelelo yokutshintsha (ukuleyibhelishwa kwakhona, ukuqinisekiswa kwakhona, ukuphinda ungenise)

Inyathelo loku-1: Chaza izinto zakho ezingaxoxisiyo malunga nesiqinisekiso sobonelelo lofakelo lwamathambo

Ukufumana indleko kulula xa uchaza 'kufuneka' ngaphambili. Ngaphandle koko, isandi ngasinye somthengisi sivakala samkelekile-de kube lixesha lokubhalisa okanye ukuhambisa.

Qala ngezi zinto zine zingaxoxiswana:

• Iimarike ekujoliswe kuzo : E-US kuphela, i-EU kuphela, okanye imimandla emininzi?

• Umda wesixhobo : umonzakalo, umqolo, umdibaniso, izixhobo, iiseti ezingenazintsholongwane, njl.

• Ulindelo lwendlela yolawulo : bobuphi ubungqina obudingayo kubhaliso lwendawo yakho kunye nokukhwela esibhedlele.

• Iimfuno zokulandeleka : iqashiso/ibhetshi/uthotho olulindelweyo, ulindelo lwe-UDI, kunye namaxesha okugcina.

Ingcebiso yePro : Bhala izinto zakho ezingaxoxisiyo njengeengxelo zokubini ('kufuneka unike u-X ngomhla ka-Y') ukuze ababoneleli bangakwazi ukuzulisa ngesandla.

Inyathelo lesi-2: Yakha ikhadi lamanqaku ukulungiselela ababoneleli ngamathambo abangabizi kakhulu

Ikhadi lamanqaku likunceda uthelekise ababoneleli kwizinto eziqhuba iziphumo-ingakumbi xa ulinganisa ixabiso kunye nomngcipheko. Ikwagcina 'ababoneleli ngamathambo abangabizi kakhulu' ekubeni bajike babe 'ngababoneleli ngexabiso eliphantsi ozisola ngalo.'

Nalu ulwakhiwo olulula onokuluqhelanisa:

Udidi	Oko ukuzuzayo	Umzekelo ubungqina obunokucelwa
Umgangatho kunye noLawulo	Ukuvuthwa kwe-QMS, ukulungela uphicotho-zincwadi, isikhalazo/ukuziphatha kweCAPA, ukulandeleka	ISO 13485 cert (umda + indawo), iCAPA SOP, iSOP yokusingatha isikhalazo, umzekelo wokulandeleka
Imisebenzi	Umthamo, amaxesha okukhokela, ukuhanjiswa kwangexesha, ukubonakala kwempahla, ukupakishwa/ulawulo lokuthumela	Isiteyitimenti samandla, i-SLA yexesha elikhokelayo, imbali yokuhanjiswa kwexesha, uluhlu lwesitokhwe, inkcazo yokupakisha
Ezorhwebo	Ukucaciswa kweendleko ezibekiweyo, i-MOQ, imiqathango yokuhlawula, uzinzo lwamaxabiso, iwaranti/imimiselo yokubuyisela	I-Quote + Incoterms, uluhlu lwe-MOQ, ixesha lokuqinisekisa ixabiso, umgaqo-nkqubo wokubuyisela

Oku kwenza izinto ezimbini:

• Ithintela 'ixabiso eliphantsi lokuphumelela' isigqibo esiwayo kamva.

• Ikunika indlela ecocekileyo yokuthethelela ukhetho lomthengisi ngaphakathi (kunye namaqela esibhedlele abuza ukuba uwufanelekele njani umthombo wakho).

Inyathelo lesi-3: Ipakethe yamaxwebhu onokuyicela (uvavanyo lwakho lokukhula ngokukhawuleza)

Ngaphambi kokuba ucwangcise uphicotho kwindawo, cela ipakethe yamaxwebhu. Ababoneleli abanamandla banokubonelela oku ngokukhawuleza-kuba sele beyidinga kubathengi kunye nabalawuli.

Apha ngezantsi luludwe lophicotho lomthengisi wesixhobo sonyango esisebenzayo kwisigaba sakho seRFI/RFQ (ukulungelelaniswa ngodidi lwesixhobo nendawo yentengiso):

A) Iziqinisekiso kunye nobungqina bophicotho-zincwadi

• Isatifikethi se-ISO 13485 (PDF) esinomniki, inombolo yesatifikethi, imihla yokuqinisekisa, idilesi yesayithi ephicothiweyo, kunye nobubanzi

• Ulwazi lwesatifikethi seCE (apho kufanelekileyo) kunye neenkcukacha zeZiko elaziswa ngalo

• Ubungqina bokulungela uphicotho-zincwadi (izishwankathelo zophicotho-zincwadi zakutsha nje, ishedyuli yokucupha, indlela yokusingatha ukungangqinelani)

Ukufumana amagqabantshintshi aluncedo malunga nokuphononongwa kuphicotho lwesixhobo sonyango, isikhokelo sika Signify kuphicotho lwezixhobo zonyango sibeka iinkalo ezingundoqo ezifana neCAPA, ulawulo lwamaxwebhu, ulungelelwaniso lolawulo lomngcipheko, kunye noqeqesho lophicotho lwangaphakathi.

B) Ukulandeleka kunye nokuleyibhile

• Indlela yokulandela umkhondo: indlela yokulandelela imathiriyeli ekrwada → WIP → iimpahla ezigqityiweyo → ukuthunyelwa

• Isampulu yokuleyibhile kunye nokuhamba komsebenzi kwe-IFU

• Indlela ye-UDI (ukuba iimarike zakho ziyayifuna) kwaye yeyiphi idatha eqhutywa kwinqanaba ngalinye lokupakisha

C) Inkqubo yomgangatho 'kufuneka uyibone' iinkqubo

• Inkqubo yeCAPA + umzekelo irekhodi yeCAPA (yaphinda yenziwa)

• Inkqubo yokusingatha isikhalazo + umzekelo irekhodi yesikhalazo (enziwe ngokutsha)

• Guqula inkqubo yolawulo (uyilo + inkqubo + utshintsho lomthengisi)

• Inkqubo yolawulo lwababoneleli (indlela abafaneleka ngayo ababoneleli babo ababalulekileyo)

D) Ubungqina bokuvelisa kunye nokuqinisekisa

Ukufakelwa kwe-orthopedic kunye nezixhobo, amandla enkqubo kaninzi apho umngcipheko womgangatho ufihla khona.

Cela i:

• Ukuhamba kwenkqubo engundoqo (umatshini → ukugqiba → ukucoca → ukuhlola → ukupakishwa)

• Indlela yokuhlola kunye nolawulo lobungakanani be-CTQ

• Ubungqina bokuqinisekisa inkqubo ekhethekileyo apho kufanelekileyo (iinkqubo apho ungenakuqinisekisa ngokupheleleyo isiphumo ngokuhlola kuphela)

E) Ubonelelo olungenazintsholongwane (kuphela ukuba iimveliso eziziintsholongwane zikhona)

Ukuba usasaza izinto ezifakelwayo ezinyumba okanye iitreyi/iiseti ezingcolileyo, cela:

• Indlela yokuqinisekisa ukuvala inzala kunye neendlela zokukhulula

• Ukupakishwa kobumbeko kunye nendlela yokuqinisekisa

• Ubomi beShelf / ingqiqo yengqibelelo (njengoko isebenza)

Kwingcaciso ekwinqanaba eliphezulu lokumakishwa kwe-CE kunye novavanyo lokuthobela phantsi kwe-MDR, ushwankathelo lwe-Kiwa lokumakishwa kwe-CE kwizixhobo zonyango phantsi kwe-MDR yindawo eluncedo yokuqala xa kulungelelaniswa okulindelwe ngamaxwebhu.

Inyathelo lesi-4: Phonononga okubalulekileyo (kwaye ungavumeli ukhenketho ukuba likuphazamise)

Ukuba iphekhi yamaxwebhu igqithise isihluzo sakho sokuqala, emva koko uphicothe. Injongo ayiko 'ukubona umzi-mveliso ococekileyo.' Kukuqinisekisa ukuba inkqubo yomgangatho womthengisi iyinyani kumgangatho wevenkile.

Gxininisa uphicotho lwakho ku:

• Ulawulo lwamaxwebhu ekusebenzeni : Ngaba banokulufumana kwakhona uguqulelo olululo ngokukhawuleza? Ngaba abaqhubi bayayilandela?

• Umboniso wokulandela umkhondo : Khetha i-SKU egqityiweyo kwaye uyilandele ngasemva (izixhobo, uhlolo, imbali eninzi).

• Umgangatho weCAPA : Ngaba uphando luyingcambu yesizathu-okanye nje 'qeqesha abasebenzi kwakhona'?

• Ulawulo lotshintsho : Bayivavanya njani impembelelo yolawulo/umthengi phambi kokuphumeza utshintsho?

• Ulawulo lwababoneleli : Ingaba bafaneleka njani ababoneleli bezinto ezibalulekileyo kunye neenkqubo zangaphandle?

Ukuba ikhonkco lakho lobonelelo lithatha imimandla emininzi, i-MDSAP inokuba luphawu olunentsingiselo. Ushwankathelo lwenkqubo ku Yintoni iMDSAP? kunye nolwandlalo lwe Indlela yophicotho lwe-MDSAP ibonisa indlela imodeli yophicotho-zincwadi ecwangciswe ngayo kuzo zonke iinkqubo ezingundoqo ze-QMS.

⚠️ Isilumkiso : Umboneleli ongayi kwabelana ngemizekelo ehlengahlengisiweyo (i-CAPA, isikhalazo, ukulandeleka) ukuxelela into-ngokuqhelekileyo ukuba inkqubo ayikavuthwanga.

Inyathelo lesi-5: Tshixa umgangatho ngeSivumelwano soMgangatho kunye nokubekwa kweliso okuqhubekayo

Nababoneleli abakhulu bayakhukuliseka ngaphandle koxanduva olucacileyo.

Ubuncinci, isiVumelwano sakho soMgangatho kufuneka sibandakanye:

• Iindima/uxanduva lwezikhalazo, uphando, kunye namaxesha okunika ingxelo

• Guqula imithetho yesaziso (loluphi utshintsho olufuna isaziso / imvume kunye nokuba kude kangakanani kwangaphambili)

• Ukulandeleka kunye neemfuno zokugcina irekhodi

• Ukuphathwa kwemveliso engahambelaniyo nemithetho yokulahla

• Ukubuyisela, ukutshintshwa, kunye nengqiqo yewaranti

• Amalungelo ophicotho-zincwadi kunye namaxesha okuphicothwa (okusekwe kumngcipheko)

Emva koko ujonge ukusebenza ngekhadi lekota elikhaphukhaphu lamanqaku:

• Ukuhanjiswa kwangexesha (OTD)

• Ukwahluka kwexesha lokukhokela

• Izinga lesikhalazo kunye nexesha lokuvala

• Ukuphindaphinda kweCAPA

• Ixesha lomjikelo wamaxwebhu (bazisa ngokukhawuleza kangakanani into oyifunayo)

Ingajongeka njani ipakethe yobungqina bomboneleli oqinileyo (umzekelo ongathathi hlangothi)

Umenzi wamathambo oqolileyo uya kuba nakho ukubonisa (okanye abonelele ngesicelo):

• Ubungqina besiqinisekiso esicacileyo (ISO 13485 / CE apho kufanelekileyo) kunye nomda ocacileyo

• Ugutyulo lwekhathalogu ebanzi kunye noqeqesho lwe-SKU (ukuze ube nokulinganisa iminikelo)

• Izibophelelo zonikezelo ezichaziweyo (ngokubonakala kwesitokhwe, hayi izithembiso ezingacacanga)

• OEM/ODM inkqubo ukucaca (ukuba yabucala-ileyibhile okanye ngokwezifiso)

Umzekelo, i-XC Medico izibeka njengofakelo lwamathambo kunye nomvelisi wesixhobo esinokhuselo olubanzi lwepotfoliyo kunye namabango esiqinisekiso; ungajonga kwakhona amagqabantshintshi abo oluntu apha Ubulunga be-XC Medico kunye nesishwankathelo sokwenziwa kunye nokuhlelwa kwemveliso kwi Iindidi zemveliso ye-XC Medico . Njengesiqhelo: phatha amaphepha oluntu njengendawo yokuqala-ke uqinisekise ngesatifikethi sePDF, umda, kunye nobungqina obubhaliweyo.

Ukuba i-OEM/ODM yinxalenye yemodeli yakho yokukhangela, i-XC Medico ikwapapasha isikhokelo esineenkcukacha sangaphakathi esakhiwe njenge Uluhlu lokukhangela lwe-OEM/ODM lwe-orthopedic , olunokuphinda kabini njenge template ye-RFI yakho.

Ii-FAQs

Zeziphi iziqinisekiso ekufuneka umthengisi wofakelo lwamathambo abe nazo?

Ubuncinane, abaninzi abasasazi baphatha i-ISO 13485 njengesiseko solawulo lwezixhobo zonyango. Xa usakha uluhlu olufutshane 'ISO 13485 umenzi wamathambo oqinisekisiweyo', sukungqina nje ukuba isatifikethi sikhona—qinisekisa umda waso (izihlomelo/izixhobo), indawo ephicothiweyo , kunye nemihla yokuqinisekisa.

Ngaphaya koko, ulwamkelo olufunekayo luxhomekeke kwiimarike ojolise kuzo kunye nodidi lwesixhobo (umzekelo, 'ukumakishwa kweCE (EU MDR) ukufakelwa kwamathambo' ubungqina beemarike zeEEA, kunye 'FDA 510(k) nofakelo lwamathambo' ubungqina bendlela yosasazo lwase-US). Undoqo kukuqinisekisa ubunyaniso bangoku kunye nobubanzi -hayi nje ilogo kwiwebhusayithi.

Ngaba i-FDA 510(k) sisiqinisekiso somthengisi?

No. A 510(k) lugunyaziso lwentengiso yesixhobo esithile, hayi isiqinisekiso senkampani ngokubanzi. Into onokuthi uyibuze kumthengisi bubungqina bokukhutshwa kwesixhobo esithile (xa buyimfuneko), kunye nobungqina bokuba basebenza ngenkqubo yomgangatho esebenzayo kwaye banokuxhasa amaxwebhu owadingayo.

Kwisiseko solawulo sase-US, i-FDA's hub yezixhobo zonyango sisiqalo esihle somxholo osemthethweni.

Ndingasebenzisa i-ISO 13485 ndedwa ukuthemba umboneleli?

Phatha i-ISO 13485 njengoko kuyimfuneko, ayanelanga. Isatifikethi sikuxelela ukuba i-QMS yaphicothwa-kodwa ayikuqinisekisi intsebenzo ngokobungakanani bemveliso yakho, ixesha lokwenyani, okanye ulawulo lotshintsho. Yiyo loo nto ipakethe yamaxwebhu + umboniso wokulandeleka + nomcimbi wesampulu yeCAPA.

Ndilinganisa njani i-MOQ ephantsi kunye nomgangatho ongaguqukiyo?

I-MOQ ephantsi inokuba yinzuzo yokukhuphisana, kodwa inokufihla ukungazinzi (ukwakha ngokukhawuleza, amaqashiso okuhlola angahambelaniyo, okanye ababoneleli abancinci abaguquguqukayo). Ukuba uodola iibhetshi ezincinci, uya kufuna izivumelwano ezingqongqo kwi:

• ukukhutshwa kwebhetshi amaxwebhu

• imithetho yovavanyo lwesampulu

• tshintsha izaziso

• amaxesha okuphendula isikhalazo

Amanyathelo alandelayo

Ukuba ufuna ukuhamba ngokukhawuleza ngaphandle kokuthatha umngcipheko ngokungeyomfuneko, yenza oku ngokulandelelana:

1. Thumela i-RFI yephepha elinye ucela uluhlu lokukhangela iphekhi yamaxwebhu ngasentla.

2. Amanqaku ababoneleli ngerubrikhi efanayo (Ubunjani/uLawulo, ukuSebenza, uRhwebo).

3. Phicotha kuphela abo bafikelele kumjikelo wokugqibela-kwaye ugxininise kuphicotho-zincwadi ekulandeleleni umkhondo, umgangatho weCAPA, kunye nolawulo lotshintsho.

Ukuba uvavanya ababoneleli kumqolo, umonzakalo, kunye neenkqubo ezidityanisiweyo kwaye ufuna iseti yereferensi yokuba 'amaxwebhu alungileyo + izibophelelo zonikezelo' zinokujongeka njani, ungaqala ngokujonga umthengisi I-XC Medico kunye nezatifikethi zesicelo kunye nepakethe yokuqinisekisa yokuqinisekisa.