Kutheni i-CE, i-FDA, kunye ne-ISO Certifications zibalulekile kubaboneleli bamazinyo

Intshayelelo

Kubaboneleli bamazinyo, uphawu lwe-CE, imvume ye-FDA, kunye nesatifikethi se-ISO ziimpawu ezisebenzayo zokuba imveliso inokuthengiswa, ithembeke, kwaye isetyenziswe ngokukhuselekileyo na kwiimeko zeklinikhi. Le migangatho ibumba ukufikelela kwimarike eYurophu, e-United States, nakwezinye iindawo ezilawulwayo ngelixa inika abathengi ubungqina obucacileyo bolawulo lokuvelisa, ukusebenza kwemveliso, kunye nokuthobela imithetho. Ukuqonda oko kuthethwa sisatifikethi ngasinye kunceda ababoneleli ukunciphisa umngcipheko wezomthetho nowezorhwebo, ukuqinisa ukuthembeka kokuthengwa, kunye nokukhuphisana ngempumelelo nabavelisi abafanelekileyo. Amacandelo angezantsi achaza indlela ezi ziqinisekiso ezichaphazela ngayo ukuzithemba komthengi, ukusasazwa kwemida, kunye nokuzinza kwexesha elide kweshishini lokubonelela ngamazinyo.

Kutheni i-CE, i-FDA, kunye ne-ISO Certifications zibalulekile kubaboneleli bamazinyo

Imakethi yezixhobo zamazinyo yehlabathi isebenza phantsi kwemithetho engqongqo kuba ezi mveliso zinempembelelo ngqoukhuseleko lwesigulanaKubathengisi bamazinyo, ukufumana uphawu lwe-CE, imvume ye-FDA, kunye neziqinisekiso ze-ISO akusiyo nje into esemthethweni, kodwa yimfuneko esisiseko yokusebenza kakuhle kwezorhwebo. Ezi ziqinisekiso zisebenza njengemilinganiselo eqhelekileyo yomgangatho, ukusebenza kakuhle, kunye nokhuseleko, nto leyo emisela amandla omthengisi okusasaza izixhobo zonyango kwiimarike zehlabathi eziphambili.

Ukunciphisa umngcipheko kunye nentembeko yomthengi

Iingcali zokuthenga kunye nabaphathi bezonyango bajongene noxanduva olukhulu xa befumana izinto ezisetyenziswayo zamazinyo kunye nezixhobo ezinkulu. Ukusebenzisa iimveliso ezingaqinisekiswanga kunyusa kakhulu amathuba eziganeko ezimbi zezonyango, ezinokubangela umonakalo omkhulu wezezimali kunye nodumo. Ngokubandakanya ababoneleli abaneziqinisekiso ezaziwayo, abathengi bayayinciphisa le mingcipheko. Uhlalutyo lwezibalo zokujonga emva kwemarike lubonisa ukuba izibonelelo eziqinisekisiweyo ze-ISO 13485 zihlala zigcina amazinga eziphene angaphantsi kwe-0.5%, xa kuthelekiswa namaziko angaqinisekiswanga apho umahluko unokudlula i-3% ukuya kwi-5%. Oku kuthembakala okubonakalayo kukhuthaza ukuthembana komthengi ixesha elide kwaye kuzinzise imisebenzi yekhonkco lokubonelela.

Ukufikelela kwimarike kunye nokulindelekileyo kokuthobela imithetho

Iziqinisekiso zilawula ukufikelela kwimarike yeendawo. I-United States ifuna imvume ye-FDA (ngesiqhelo i-510(k) yezixhobo zeKlasi yesiBini), ngelixa i-European Union iyalela ukuba uphawu lwe-CE luphawulwe phantsi koMgaqo-nkqubo ongqongqo weZixhobo zoNyango (MDR 2017/745). Ngaphandle kwezi mvume, ababoneleli bamazinyo bayathintelwa ngokusemthethweni ekuthengiseni iimveliso zabo kwezi ndawo zinengeniso. Umzekelo, ukungathobeli i-EU MDR kunokubangela ukuba kukhutshwe imveliso kwangoko kuwo onke amazwe angamalungu angama-27, oku kuthintele ngempumelelo imarike exabisa ngaphezulu kwe-€15 yeebhiliyoni ngonyaka. Ngenxa yoko, amaqela okuthenga alindele ukuba ababoneleli baqhubeke nokuthobela imithetho ukuze bathintele ukuphazamiseka kwekhonkco lokubonelela ngequbuliso okubangelwa zizenzo zokunyanzeliswa komthetho.

Kuthetha ukuthini i-CE, i-FDA, kunye ne-ISO Certifications

Ukuhambahamba kwindawo yokulawula kufuna ukuqonda ngokuchanekileyo ukuba isiqinisekiso ngasinye sithetha ukuthini. Nangona zihlala zihlanganiswa, ukumakishwa kwe-CE, imvume ye-FDA, kunye nesatifikethi se-ISO zisebenza imisebenzi eyahlukeneyo yezomthetho kunye nokusebenza kwinkqubo yokuvelisa amazinyo.

Ukumakishwa kwe-CE ngokuchasene nemvume ye-FDA ngokuchasene nesiqinisekiso se-ISO

Isatifikethi se-ISO, ngakumbi i-ISO 13485, silawula iNkqubo yoLawulo loMgangatho (i-QMS) yomenzi wezixhobo zonyango, siqinisekisa uyilo oluhambelanayo, uphuhliso, kunye neenkqubo zemveliso. Ngokwahlukileyo koko, ukuvunyelwa kwe-FDA kunye nokumakishwa kwe-CE ziimvume zemarike ezithile zemveliso.

Ukuhlelwa kwemveliso kunye neendlela zokuqinisekiswa

Izixhobo zamazinyo zahlulwe ngokwengozi, nto leyo elawula indlela yokuqinisekiswa. I-FDA ihlela izixhobo zibe yiKlasi I (umngcipheko ophantsi, umz., iibrashi zamazinyo ezenziwe ngesandla), iKlasi II (umngcipheko ophakathi, umz., i-dental amalgam, izibane zokulungisa), kunye neKlasi III (umngcipheko ophezulu, umz., izinto zokufakelwa kwamathambo). Isixhobo esiqhelekileyo seKlasi II sifuna isaziso sangaphambi kwemarike se-510(k), esibonisa ukulingana okukhulu nesixhobo esichazwe ngokusemthethweni kwaye ngokubanzi sithatha iintsuku ezingama-90 ukuya kwezi-180 ukuze sivulwe. Phantsi kwe-EU MDR, ukuhlelwa kuhlanganisa iKlasi I, IIa, IIb, kunye ne-III. Indlela yeKlasi IIa okanye isixhobo esiphezulu iyalela uvavanyo lokuhambelana neNyaniso yiBhunga eliNazisiweyo, inkqubo enzima enokuthabatha iinyanga ezili-12 ukuya kwezingama-24 kwaye ifuna ubungqina obuninzi beklinikhi.

Umahluko phakathi kobubanzi kunye namaxwebhu

Umthwalo wamaxwebhu wahluka kakhulu phakathi kwezi zikhokelo. I-ISO 13485 ifuna iincwadana ze-QMS ezipheleleyo, iirekhodi zophicotho lwangaphakathi, kunye neenkqubo zophononongo lolawulo. Ukungeniswa kwe-FDA kufuna iRekhodi yeSixhobo esiPhambili (i-DMR) ecwangcisiweyo kunye neFayile yeMbali yoYilo (i-DHF). Uphawu lwe-CE phantsi kwe-MDR luzisa iimfuno ezibanzi ngakumbi, kubandakanya ukuLandelelwa kweKlinikhi emva kweMarike (i-PMCF) kunye neeNgxelo zoHlaziyo loKhuseleko oluPhilayo (i-PSUR). Ababoneleli kufuneka babelane ngezixhobo ezibalulekileyo zokugcina ezi fayile zobugcisa; ukungaphumeleli kophicotho okanye ukungabikho kwengxelo enye yovavanyo lweklinikhi efunekayo kunokubangela ukumiswa kwangoko kwamalungelo okuthengisa.

Indlela Iziqinisekiso Ezichaphazela Ngayo Umgangatho Womthengisi

Ngaphaya kokuthobela imithetho, ukulandela nokugcina ezi ziqinisekiso kuguqula ngokusisiseko uyilo lokusebenza komthengisi. Ababoneleli bamazinyo abaqinisekisiweyo babonisa uqeqesho oluphuculweyo lokuvelisa, oluthetha ngokuthe ngqo imveliso egqwesileyo.umgangatho kunye nokuthembekakumsebenzisi wokugqibela.

Ukulandeleka kunye nolawulo lomgangatho

Isiseko se-ISO 13485 kunye ne-FDA 21 CFR Icandelo 820 kukulandeleka ukusuka ekuqaleni ukuya ekupheleni. Ababoneleli abaqinisekisiweyo baphumeza iinkqubo zokulandelela amabala kunye neenkqubo zokuchongwa kwesixhobo esikhethekileyo (UDI). Oku kuqinisekisa ukuba isixhobo ngasinye samazinyo okanye izinto eziphilayo zinokulandelelwa zibuyele kwibhetshi yaso yezinto eziluhlaza kunye notshintsho oluthile lokuvelisa. Ngokwendlela esebenzayo, ukuba iqela elingalunganga le-composite yamazinyo lichongiwe, umthengisi oqinisekisiweyo unokuqhuba ukurhoxiswa okujoliswe kuko kwiiyure ezingama-24 ukuya kuma-48, ehlukanisa i-lot echanekileyo yeeyunithi ezingama-500 endaweni yokurhoxiswa kwamawaka amashumi eeyunithi ngokungakhethiyo. Oku kunciphisa ukushaqeka kwekhonkco lokubonelela.

Isantya, iindleko, kunye nokuhambelana nomthetho

Ukufikelela kweli nqanaba lolawulo lomgangatho kwazisa urhwebo oluyimfuneko phakathi kwesantya, iindleko, kunye nokuthobela imithetho. Ukusebenzisa i-QMS ehambelanayo kunye nokufumana isatifikethi sokuqala se-ISO 13485 kudla ngokufuna utyalo-mali oluqala kwi-$20,000 ukuya kwi-$50,000. Oku akubandakanyi iifizi zonyaka eziphindaphindayo zokuhlolwa okanye iindleko ezithile zobhaliso lwemveliso ye-FDA kunye ne-CE, ezinokudlula ngokulula i-$100,000 kwizixhobo ezintsonkothileyo zeClass IIb okanye III. Ngenxa yoko, ababoneleli abaqinisekisiweyo badla ngokuba neMinimum Order Quantities (MOQs) okanye amaxabiso eyunithi aphezulu xa kuthelekiswa nabakhuphisana nabo abangengobasemthethweni kwimarike. Nangona kunjalo, abathengi bayazilungisa ezi ntlawulo zangaphambili ngokuphepha iindleko ezifihlakeleyo zamaxabiso aphezulu eziphene, ukwaliwa kokuthunyelwa kwimpahla kwimpahla yasekhaya, kunye namatyala anokubakho okungasebenzi kakuhle.

Iikhrayitheriya eziphambili zovavanyo lomthengi

Xa kuvavanywa ababoneleli bamazinyo abanokubakho, amaqela okuthenga kufuneka ajonge ngaphaya kobukho nje besatifikethi. Iikhrayitheriya eziphambili zovavanyo kufuneka zibandakanye ukuqina kwenkqubo yomboneleli ye-Corrective and Preventive Action (CAPA), amaxesha abo embali okuphendula ekungahambelani nomgangatho, kunye nokuphindaphindwa kokuhlolwa kwabo kwangaphakathi. Umboneleli osebenzisa ngokukhutheleyo inkqubo yakhe ye-CAPA ukuqhuba uphuculo oluqhubekayo—olubonakaliswa kukunciphisa okulinganiselweyo kwezikhalazo zabathengi kwixesha leenyanga ezili-12—ubonisa inkcubeko yomgangatho ovuthiweyo edlula iimfuno zomthetho ezisisiseko.

Indlela Abathengi Abafanele Baqinisekise Ngayo Amabango Esiqinisekiso

Ukuxhaphaka kweziqinisekiso zobuqhetseba okanye eziphelelwe lixesha kwicandelo lemveliso lehlabathi kufuna uqwalaselo oluqatha. Iingcali zokuthenga azinakwamkela amaxwebhu ngokwexabiso eliphantsi; ukuqinisekiswa okungqongqo kubalulekile ukukhusela ukuthembeka kwekhonkco lokubonelela ngamazinyo.

Amaxwebhu okufuneka uwacele kubaboneleli

Ukungeniswa kokuqala komthengisi kufuneka kuquke isicelo esisemthethweni samaxwebhu athile olawulo. Abathengi kufuneka bafune isatifikethi se-ISO 13485 sangoku, iSibhengezo se-EU sokuThotyelwa kweMithetho (i-DoC), uBhaliso lwe-FDA Establishment, kunye neleta ethile ye-510(k) yemvume yezixhobo ekujoliswe kuzo. Ukongeza, ukucela ingxelo yesishwankathelo yamva nje evela kwi-Notified Body audit okanye kwi-FDA Establishment Inspection Report (i-EIR) kunika ulwazi olunzulu malunga nesimo sokuthobela esiqhubekayo somthengisi kunye nazo naziphi na izinto ezingathotyelwanga kutshanje.

Indlela yokuqinisekisa ubhaliso kunye nezatifikethi

Ukuba noxwebhu akwanelanga; ubunyani balo kufuneka buqinisekiswe ngokuzimeleyo ngeendlela ezisemthethweni.

Abathengi kufuneka babhekisele ngqo kwigama lenkampani kunye nedilesi yesakhiwo sokuvelisa kwisatifikethi kunye nesiseko sedatha esisemthethweni. Umahluko—njengesatifikethi esinikwe inkampani engumzali kodwa kungekhona inkampani ethile eyenza izitulo zamazinyo—umele uphawu olubalulekileyo lokuthobela imithetho.

Inkqubo yokuqwalasela ngokukuko

Umsebenzi wophando olusebenzayo kufuneka ulandele indlela ecwangcisiweyo, enamanqanaba amaninzi. Okokuqala, yenza uqinisekiso lwedijithali lokuqala ngokuchasene needathabheyisi zikawonke-wonke. Oku kudla ngokuthatha ngaphantsi kweeyure ezingama-48 kodwa kunokucoca abathengisi abakhohlisayo ngoko nangoko. Okwesibini, qinisekisa umda; qinisekisa ukuba isatifikethi se-ISO 13485 sigubungela ngokucacileyo "izixhobo zamazinyo"okanye" izinto zokulungisa amazinyo" endaweni yokwenziwa kwesinyithi esiqhelekileyo. Okokugqibela, yalela ukuba kwenziwe uhlolo lomntu wesithathu kwindawo ngaphambi kokuba kugqitywe nayiphi na ikhontrakthi edlula umda wemali ochazwe kwangaphambili, njenge-$50,000 kwinkcitho yonyaka. Olu qinisekiso olubonakalayo luqinisekisa ukuba i-QMS echazwe kuxwebhu isetyenziswa ngokukhutheleyo kumgangatho wefektri.

Indlela yokwenza izigqibo ezingcono zesatifikethi kunye nezigqibo zokufumana ulwazi

Ukuphucula uthungelwano lokubonelela ngamazinyo kufuna ulungelelwaniso olucwangcisiweyo phakathi kweeprofayili zomngcipheko wemveliso, iimfuno zomthetho, kunye neenjongo zokuthenga. Abathengi kufuneka baphuhlise izikhokelo zokufumana izinto ezisebenzisa izatifikethi njengesixhobo sokudala ixabiso endaweni yokuzibona njengemiqobo yolawulo kuphela.

Ukubeka phambili utyalo-mali lwesatifikethi

Imibutho kufuneka ibeke phambili iimfuno zesatifikethi ngokusekelwe kuhlu lwezixhobo kunye nokusetyenziswa kweklinikhi okucwangcisiweyo. Kwizixhobo zeClass I ezingenazintsholongwane, ezifana nezipili zovavanyo olusisiseko, ukugxininisa kwisatifikethi seCE MDR esintsonkothileyo esivela kwiNotified Body ephezulu kunokunyusa iindleko ngokungeyomfuneko. Ngokwahlukileyo koko, kwizixhobo ezifakelwayo zeClass III, ukuyekelela kwiziqinisekiso ze-FDA okanye ze-CE akunakuxoxiswana ngazo. Amaqela okuthenga kufuneka agunyazise i-ISO 13485 njengomgangatho osisiseko kwi-100% yababoneleli babo ababalulekileyo, ukuqinisekisa inqanaba elisisisekoulawulo lomgangathokuyo yonke inkqubo yomthengisi ngaphambi kokuvavanya ugunyaziso oluthile lwemveliso.

Ukulinganisela ukuthobela imithetho, iindleko, kunye nomngcipheko wokubonelela

Ukulinganisela ukuthobela imithetho, iindleko, kunye nomngcipheko wokubonelela kubandakanya ukwamkela isicwangciso sepotifoliyo yomthengisi esinamanqanaba. Ukuthembela kumthengisi omnye, oqinisekisiweyo kakhulu kwindawo ekumgangatho ophezulu kunciphisa umngcipheko wokuthobela imithetho kodwa kwandisa iindleko kunye nokuba sesichengeni kokuphazamiseka kwendawo. Ngokwahlukileyo koko, ukufumana kuphela kwiindawo ezingabizi kakhulu ngaphandle kokujonga isiqinisekiso esingqongqo kumema ukusilela okukhulu kwemithetho kunye nomgangatho. Indlela elungeleleneyo inokwabela i-70% ukuya kwi-80% yomthamo wezixhobo zamazinyo ezibalulekileyo kubaboneleli abaphambili abasele beqinisekisiwe, abaqinisekisiweyo ngokupheleleyo (FDA/CE/ISO), ngelixa bephuhlisa ababoneleli besibini abane-ISO 13485 kwaye betyala imali ngokukhutheleyo kwiindlela ze-FDA/CE. Esi sicwangciso sibonelela ngexabiso eliphantsi kunye nokuphinda kubonelelwe ngeenkonzo ngelixa kugcinwa umda ongqongqo kumngcipheko owamkelekileyo weklinikhi.

Izinto ezibalulekileyo ekufuneka ziqwalaselwe

• Izigqibo ezibalulekileyo kunye nesizathu sokuba abaNiki bamazinyo
• Iinkcukacha, ukuthobela imithetho, kunye nokuhlolwa komngcipheko okufuneka kuqinisekiswe ngaphambi kokuba uzibophelele
• Amanyathelo alandelayo asebenzayo kunye nezilumkiso abafundi abanokuzisebenzisa ngoko nangoko

Imibuzo ebuzwa qho

Kutheni ndifanele ndikhethe umthengisi we-orthodontic oqinisekisiweyo yi-CE, i-FDA, kunye ne-ISO13485?

Ezi ziqinisekiso zibonisa ukuba umthengisi uhlangabezana nemigangatho yokhuseleko, umgangatho, kunye nokuthobela eyamkelekileyo, enciphisa umngcipheko wemveliso kwaye enceda ukuqinisekisa ukuthengiswa okusemthethweni kwiimarike eziphambili ezifana ne-EU kunye ne-US.

Ngaba iDenrotary ineziqinisekiso zokubonelela ngeenkonzo ze-orthodontic zehlabathi?

Ewe. I-Denrotary ithi ineziqinisekiso ze-CE, FDA, kunye ne-ISO13485, ixhasa ukwenziwa okulawulwa ngumgangatho kunye nentsebenziswano yamazwe ngamazwe egudileyo.

Zeziphi iimveliso zeDenrotary ezixhamla kakhulu kwimveliso eqinisekisiweyo?

Izinto eziphambili ze-orthodontic ezifana neebrackets ezizibophelelayo, ii-buccal tubes, ii-arch wires, ii-power chains, kunye ne-pliers ziyazuza ngokusebenza ngcono, ukulandeleka, kunye nokusebenza ngokukhuselekileyo kweklinikhi.

Izatifikethi zibanceda njani abathengi ukuba baphephe iingxaki zokuthengwa kwempahla?

Ababoneleli abaqinisekisiweyo abanakukwazi ukujongana nemiqobo yemithetho okanye uphicotho olungaphumelelanga. Oko kunceda iikliniki kunye nabasasazi ukuba bagcine ukuthengwa kwezinto kuzinzile kwaye kuthintele ukuphazamiseka kokuthunyelwa ngequbuliso okanye ukufikelela kwimarike.

Zeziphi iimpawu zomgangatho ezisebenzisekayo ekufuneka ndizijonge ngaphandle kweziqinisekiso?

Cela ukulandelelwa kwebhetshi, iirekhodi zovavanyo lwemveliso, iinkcukacha zezinto ezisetyenzisiweyo, kunye nokukwazi kwefektri. KwiDenrotary, imizekelo ibandakanya iiworkshops zodidi lwezonyango, izixhobo zaseJamani, kunye nemigca yokuvelisa izibiyeli ezenzekelayo.