Kungani Izitifiketi ze-CE, FDA, kanye ne-ISO Zibalulekile Kubahlinzeki Bamazinyo

Isingeniso

Kubahlinzeki bamazinyo, ukumakwa kwe-CE, imvume ye-FDA, kanye nesitifiketi se-ISO kuyizimpawu ezisebenzayo zokuthi umkhiqizo ungathengiswa, uthembeke, futhi usetshenziswe ngokuphephile yini ezindaweni zezokwelapha. Lezi zindinganiso zakha ukufinyelela emakethe eYurophu, e-United States, nakwezinye izifunda ezilawulwayo ngenkathi zinikeza abathengi ubufakazi obucacile bokulawulwa kokukhiqiza, ukusebenza komkhiqizo, kanye nokuhambisana nemithetho. Ukuqonda ukuthi isitifiketi ngasinye simelelani kusiza abahlinzeki ukunciphisa ingozi yezomthetho neyezentengiselwano, kuqinise ukwethembeka kokuthengwa, futhi kuncintisane ngempumelelo nabakhiqizi abafanelekayo. Izigaba ezingezansi zichaza ukuthi lezi ziqinisekiso zithinta kanjani ukuzethemba komthengi, ukusatshalaliswa kwemingcele, kanye nokuzinza kwesikhathi eside kwebhizinisi lokuhlinzeka ngamazinyo.

Kungani Izitifiketi ze-CE, FDA, kanye ne-ISO Zibalulekile Kubahlinzeki Bamazinyo

Imakethe yemishini yamazinyo yomhlaba wonke isebenza ngaphansi kwezinhlaka zomthetho eziqinile ngoba le mikhiqizo ithinta ngqoukuphepha kwesiguli. Kubahlinzeki bamazinyo, ukuthola uphawu lwe-CE, imvume ye-FDA, kanye nezitifiketi ze-ISO akuyona nje into ehlelekile, kodwa kuyimfuneko eyisisekelo yokusebenza kahle kwezentengiselwano. Lezi ziqinisekiso zisebenza njengezilinganiso ezijwayelekile zekhwalithi, ukusebenza kahle, kanye nokuphepha, okunquma ikhono lomhlinzeki lokusabalalisa amadivayisi ezokwelapha ezimakethe zomhlaba wonke eziyinhloko.

Ukunciphisa ubungozi kanye nokwethenjwa komthengi

Ochwepheshe bokuthenga kanye nabaphathi bezokwelapha babhekene nesibopho esikhulu lapho bethola izinto ezisetshenziswayo zamazinyo kanye nemishini eyinhloko. Ukusebenzisa imikhiqizo engaqinisekisiwe kukhulisa kakhulu amathuba emicimbi emibi yezokwelapha, okungaholela ekulimaleni okukhulu kwezezimali kanye nedumela. Ngokubandakanya abahlinzeki abanezitifiketi eziqashelwayo, abathengi banciphisa lezi zingozi. Ukuhlaziywa kwezibalo kokubhekwa ngemuva kwemakethe kubonisa ukuthi izikhungo eziqinisekiswe yi-ISO 13485 zihlala zigcina amazinga okukhubazeka angaphansi kuka-0.5%, uma kuqhathaniswa nezinhlangano ezingaqinisekisiwe lapho ukuguquguquka kungadlula khona u-3% kuya ku-5%. Lokhu kuthembeka okubonakalayo kukhuthaza ukwethenjwa komthengi isikhathi eside futhi kuzinzise ukusebenza kweketanga lokuhlinzeka.

Ukufinyelela emakethe kanye nokulindelwe kokuthobela imithetho

Izitifiketi ziqondisa ukufinyelela emakethe yendawo. I-United States idinga imvume ye-FDA (ngokuvamile i-510(k) yamadivayisi eSigaba II), kuyilapho i-European Union iyalela ukumaka kwe-CE ngaphansi koMthethonqubo Oqinile Wedivayisi Yezokwelapha (MDR 2017/745). Ngaphandle kwalezi zimvume, abahlinzeki bamazinyo bavinjelwe ngokomthetho ukuthengisa imikhiqizo yabo kulezi zifunda ezinenzuzo. Isibonelo, ukungalandeli i-EU MDR kungaholela ekukhishweni emakethe ngokushesha kuwo wonke amazwe angamalungu angu-27, okuphumela ekuqedeni imakethe enenani elingaphezu kwama-€15 billion ngonyaka. Ngenxa yalokho, amaqembu okuthenga alindele abahlinzeki ukuthi bagcine ukuthobela imithetho ukuze bavimbele ukuphazamiseka okungazelelwe kochungechunge lokuhlinzekwa okubangelwa yizenzo zokuphoqelela umthetho.

Kusho ukuthini ukuthi izitifiketi ze-CE, FDA, kanye ne-ISO zisho ukuthini

Ukuzulazula endaweni yokulawula kudinga ukuqonda okunembile ukuthi kusho ukuthini ukuqinisekiswa ngakunye. Nakuba kuvame ukuhlanganiswa ndawonye, ​​ukumakwa kwe-CE, imvume ye-FDA, kanye nesitifiketi se-ISO kufeza imisebenzi ehlukile yezomthetho kanye nokusebenza ngaphakathi kohlelo lokukhiqiza amazinyo.

Ukumaka kwe-CE vs imvume ye-FDA vs isitifiketi se-ISO

Isitifiketi se-ISO, ikakhulukazi i-ISO 13485, silawula i-Quality Management System (QMS) yomkhiqizi wedivayisi yezokwelapha, siqinisekisa ukwakheka, ukuthuthukiswa, kanye nezinqubo zokukhiqiza ezihambisanayo. Ngakolunye uhlangothi, ukuvunyelwa kwe-FDA kanye nokumakwa kwe-CE kuyimvume yemakethe ethile yomkhiqizo.

Ukuhlukaniswa komkhiqizo kanye nezindlela zokuqinisekisa

Amadivayisi amazinyo ahlukaniswa ngengozi, okunquma indlela yokuqinisekisa. I-FDA ihlukanisa amadivayisi ngeSigaba I (ingozi ephansi, isib. amabhulashi amazinyo enziwe ngesandla), Isigaba II (ingozi ephakathi, isib. i-dental amalgam, izibani zokukhanyisa), kanye neSigaba III (ingozi ephezulu, isib. izinto zokufakelwa amathambo). Idivayisi ejwayelekile yeSigaba II idinga isaziso sangaphambi kwemakethe esingu-510(k), esibonisa ukulingana okukhulu nedivayisi ebikezelayo ethengiswa ngokusemthethweni futhi ngokuvamile ithatha izinsuku ezingu-90 kuya kwezingu-180 ukuze ikhishwe. Ngaphansi kwe-EU MDR, ukuhlukaniswa kuhlanganisa iSigaba I, IIa, IIb, kanye ne-III. Indlela yedivayisi yeSigaba IIa noma ephezulu idinga ukuhlolwa kokuhambisana yiNhlangano Eyaziswayo, inqubo enzima engathatha izinyanga ezingu-12 kuya kwezingu-24 futhi idinga ubufakazi obuningi bezokwelapha.

Umehluko wobubanzi kanye nombhalo

Umthwalo wemibhalo uyahluka kakhulu phakathi kwalezi zinhlaka. I-ISO 13485 idinga amabhukwana e-QMS aphelele, amarekhodi okuhlolwa kwangaphakathi, kanye nezinqubo zokubuyekezwa kokuphathwa. Ukuthunyelwa kwe-FDA kudinga iRekhodi Eyinhloko Yedivayisi (i-DMR) ehlelekile kanye neFayili Yomlando Wokuklama (i-DHF). Uphawu lwe-CE ngaphansi kwe-MDR luveza izidingo ezibanzi nakakhulu, kufaka phakathi i-proactive Post-Market Clinical Follow-up (i-PMCF) kanye ne-Periodic Safety Update Reports (i-PSUR). Abahlinzeki kumele babelane ngezinsizakusebenza ezinkulu zokugcina lawa mafayela obuchwepheshe; ukwehluleka ukuhlolwa noma ukuntuleka kombiko owodwa wokuhlolwa komtholampilo odingekayo kungabangela ukumiswa ngokushesha kwamalungelo okuhweba.

Indlela Izitifiketi Ezithinta Ngayo Ikhwalithi Yomhlinzeki

Ngale kokuthobela imithetho, ukuphishekela nokugcina lezi zitifiketi kuguqula ngokuyisisekelo ukwakheka kokusebenza komhlinzeki. Abahlinzeki bamazinyo abaqinisekisiwe babonisa isiyalo esithuthukisiwe sokukhiqiza, okuhunyushwa ngqo kumkhiqizo osezingeni eliphezulu.ikhwalithi nokuthembekakumsebenzisi wokugcina.

Ukulandelela kanye nokulawula ikhwalithi

Isisekelo se-ISO 13485 kanye ne-FDA 21 CFR Ingxenye 820 ukulandeleka kusukela ekuqaleni kuya ekugcineni. Abahlinzeki abaqinisekisiwe basebenzisa izinhlelo zokulandelela izindawo eziqinile kanye nezinqubo zokuhlonza idivayisi ezihlukile (UDI). Lokhu kuqinisekisa ukuthi yonke into yamazinyo noma izinto eziphilayo zingalandelelwa emuva kuqoqo layo lezinto zokusetshenziswa kanye noshintsho oluthile lokukhiqiza. Ngokwemibandela engokoqobo, uma kutholakala iqembu elingalungile lenhlanganisela yamazinyo, umhlinzeki oqinisekisiwe angenza ukukhushulwa okuqondiwe kungakapheli amahora angama-24 kuya kwangu-48, ehlukanisa indawo eqondile yamayunithi angu-500 kunokuba akhushulwe amashumi ezinkulungwane zamayunithi ngokungakhethi. Lokhu kunciphisa ukushaqeka kochungechunge lokuhlinzeka.

Isivinini, izindleko, kanye nokuhambisana nemithetho

Ukufinyelela leli zinga lokulawula ikhwalithi kuletha ukuhwebelana okudingekayo phakathi kwesivinini, izindleko, kanye nokuthobela imithetho. Ukusebenzisa i-QMS ehambisanayo nokuthola isitifiketi sokuqala se-ISO 13485 ngokuvamile kudinga ukutshalwa kwezimali okusukela ku-$20,000 kuya ku-$50,000. Lokhu akubandakanyi izimali zokuhlola zonyaka eziphindaphindayo noma izindleko ezithile zokubhaliswa komkhiqizo we-FDA kanye ne-CE, ezingadlula kalula u-$100,000 kumadivayisi ayinkimbinkimbi e-Class IIb noma III. Ngenxa yalokho, abahlinzeki abaqinisekisiwe bavame ukuba ne-Minimum Order Quantities (MOQs) noma amanani eyunithi aphezulu uma kuqhathaniswa nabancintisana abangaqinisekisiwe emakethe empunga. Kodwa-ke, abathengi banciphisa lawa maphrimiyamu angaphambili ngokugwema izindleko ezifihliwe zamanani aphezulu okukhubazeka, ukwenqatshwa kokuthunyelwa kwamasiko, kanye nezikweletu ezingaba khona zokungasebenzi kahle.

Izindlela ezibalulekile zokuhlola umthengi

Lapho kuhlolwa abahlinzeki bamazinyo abangaba khona, amaqembu okuthenga kumele abheke ngale kokuba khona nje kwesitifiketi. Izindlela ezibalulekile zokuhlola kufanele zifake ukuqina kohlelo lomhlinzeki lwe-Corrective and Preventive Action (CAPA), izikhathi zabo zokuphendula zomlando ekungahambelani nekhwalithi, kanye nokuvama kwabo kokuhlolwa kwangaphakathi. Umhlinzeki osebenzisa ngenkuthalo uhlelo lwakhe lwe-CAPA ukuze aqhube intuthuko eqhubekayo—okufakazelwa ukwehla okulinganiselwe kwezikhalazo zamakhasimende esikhathini esiyizinyanga ezingu-12—ubonisa isiko lekhwalithi elivuthiwe elidlula izidingo zomthetho eziyisisekelo.

Indlela Abathengi Okufanele Baqinisekise Ngayo Izimangalo Zesitifiketi

Ukusabalala kwezitifiketi zokukhwabanisa noma eziphelelwe yisikhathi emkhakheni wokukhiqiza womhlaba wonke kudinga ukucophelela okukhulu. Ochwepheshe bokuthenga abakwazi ukwamukela amadokhumenti ngokubheka ukuthi asebenza kanjani; ukuqinisekiswa okuqinile kubalulekile ukuze kuvikelwe ubuqotho bochungechunge lokuhlinzekwa kwamazinyo.

Amadokhumenti okufanele uwacele kubaphakeli

Ukungeniswa kokuqala komhlinzeki kumele kufake isicelo esisemthethweni semibhalo ethile yokulawula. Abathengi kufanele bafune isitifiketi samanje se-ISO 13485, i-EU Declaration of Conformity (DoC), i-FDA Establishment Registration, kanye nencwadi ethile yokuqinisekisa i-510(k) yamadivayisi aqondiwe. Ngaphezu kwalokho, ukucela umbiko ofingqiwe wakamuva kakhulu ovela ku-Notified Body audit noma ku-FDA Establishment Inspection Report (EIR) kunikeza ukuqonda okujulile ngesimo sokuthobela umthetho esiqhubekayo somhlinzeki kanye nanoma yikuphi ukungalandeli imithetho kwakamuva.

Indlela yokuqinisekisa ukubhaliswa kanye nezitifiketi

Ukuba nedokhumenti akwanele; ubuqiniso bayo kumele buqinisekiswe ngokuzimela ngemigudu esemthethweni.

Abathengi kumele babhekisele ngqo egameni lenkampani kanye nekheli lendawo yokukhiqiza esitifiketini kanye nesizindalwazi esisemthethweni. Ukungafani—njengesitifiketi esinikezwe inkampani engumzali kodwa hhayi inkampani ethile ekhiqiza izihlalo zamazinyo—kumele ifulege elibalulekile lokuthobela imithetho.

Inqubo yokuhlolisisa ngokufanele

Umsebenzi wokuhlola okusebenzayo kufanele ulandele indlela ehlelekile nenezigaba eziningi. Okokuqala, yenza ukuqinisekiswa kwedijithali kokuqala ngokumelene nezizindalwazi zomphakathi. Lokhu ngokuvamile kudinga amahora angaphansi kwama-48 kodwa kungahlunga ngokushesha abathengisi abakhohlisayo. Okwesibili, qinisekisa ububanzi; qinisekisa ukuthi isitifiketi se-ISO 13485 simboza ngokucacile "amathuluzi amazinyo"noma" izinto zokuhlobisa amazinyo" kunokuba kwenziwe insimbi ejwayelekile. Okokugcina, nikeza igunya lokuhlolwa kwendawo yomuntu wesithathu ngaphambi kokuphothula noma iyiphi inkontileka edlula umkhawulo wezezimali ochazwe kusengaphambili, njenge-$50,000 ekusetshenzisweni konyaka. Lokhu kuqinisekiswa okungokoqobo kuqinisekisa ukuthi i-QMS echazwe kumadokhumenti isetshenziswa ngenkuthalo phansi efektri.

Indlela Yokwenza Izinqumo Ezingcono Zokuqinisekisa Nokuthola Isitifiketi

Ukuthuthukisa uchungechunge lokuhlinzekwa kwamazinyo kudinga ukuhambisana kwamasu phakathi kwamaphrofayili engozi yomkhiqizo, izidingo zomthetho, kanye nezinhloso zokuthengwa. Abathengi kumele bathuthukise izinhlaka zokuthola ulwazi ezisebenzisa izitifiketi njengethuluzi lokudala inani kunokuzibheka njengezithiyo zokuphatha kuphela.

Ukubeka phambili ukutshalwa kwezimali kwesitifiketi

Izinhlangano kumele zibeke phambili izidingo zesitifiketi ngokusekelwe ekuhlukanisweni kwedivayisi kanye nokusetshenziswa okuhlosiwe kwezokwelapha. Kumadivayisi angewona ahlanzekile eSigaba I, njengezibuko zokuhlola eziyisisekelo, ukugcizelela isitifiketi se-CE MDR esiyinkimbinkimbi esivela ku-Notified Body ephezulu kungenza izindleko zikhuphuke ngokungadingekile. Ngakolunye uhlangothi, kumadivayisi afakelwa i-Class III, ukuyekethisa eziqinisekisweni ze-FDA noma ze-CE akunakuxoxiswana ngakho. Amaqembu okuthenga kufanele agunyaze i-ISO 13485 njengendinganiso eyisisekelo yabahlinzeki bawo ababalulekile abayi-100%, okuqinisekisa izinga eliyisisekeloukuphathwa kwekhwalithikulo lonke uhlelo lomthengisi ngaphambi kokuhlola ukugunyazwa komkhiqizo othize.

Ukulinganisela ukuthobela imithetho, izindleko, kanye nengozi yokuhlinzeka

Ukulinganisela ukuthobela imithetho, izindleko, kanye nengozi yokuhlinzeka kuhilela ukwamukela isu lephothifoliyo yomhlinzeki elisezingeni eliphezulu. Ukuthembela kumhlinzeki oyedwa, oqinisekisiwe kakhulu endaweni ephezulu kunciphisa ingozi yokuthobela imithetho kodwa kwandisa izindleko kanye nobuthakathaka bokuphazamiseka kwendawo. Ngakolunye uhlangothi, ukuthola kuphela ezindaweni ezingabizi kakhulu ngaphandle kokubhekwa kwesitifiketi okuqinile kumema ukwehluleka okukhulu kokulawula kanye nekhwalithi. Indlela elinganiselayo ingase inikeze u-70% kuya ku-80% wevolumu yezinto ezibalulekile zamazinyo kubahlinzeki abayinhloko abasunguliwe, abaqinisekisiwe ngokugcwele (FDA/CE/ISO), ngenkathi kuthuthukiswa abahlinzeki besibili abane-ISO 13485 futhi abatshala imali ngenkuthalo ezindleleni ze-FDA/CE. Leli su lihlinzeka ngesilinganiso sezindleko kanye nokwehliswa kwezindleko ngenkathi kugcinwa umkhawulo oqinile engcupheni yezokwelapha eyamukelekayo.

Izinto Ezibalulekile Okufanele Uzicabangele

• Iziphetho ezibaluleke kakhulu kanye nesizathu sabahlinzeki bamazinyo
• Imininingwane, ukuhambisana, kanye nokuhlolwa kwengozi okufanele kuqinisekiswe ngaphambi kokuthi uzibophezele
• Izinyathelo ezilandelayo ezisebenzayo kanye nezixwayiso abafundi abangazisebenzisa ngokushesha

imibuzo ejwayelekile ukubuzwa

Kungani kufanele ngikhethe umhlinzeki we-orthodontic oqinisekiswe yi-CE, FDA, kanye ne-ISO13485?

Lezi zitifiketi zibonisa ukuthi umhlinzeki uhlangabezana nezindinganiso zokuphepha, ikhwalithi, kanye nokuhambisana nemithetho eziqashelwayo, okunciphisa ubungozi bomkhiqizo futhi kusiza ukuqinisekisa ukuthengiswa okusemthethweni ezimakethe ezibalulekile njenge-EU kanye ne-US.

Ingabe iDenrotary inezitifiketi zokuhlinzekwa kwe-orthodontic emhlabeni jikelele?

Yebo. I-Denrotary ithi inezitifiketi ze-CE, FDA, kanye ne-ISO13485, isekela ukukhiqizwa okulawulwa yikhwalithi kanye nokubambisana kwamazwe ngamazwe okubushelelezi.

Yimiphi imikhiqizo yeDenrotary ezuza kakhulu ekukhiqizweni okuqinisekisiwe?

Izinto eziyinhloko ze-orthodontic ezifana nama-bracket azimele, amashubhu e-buccal, izintambo ze-arch, amaketanga kagesi, kanye ne-pliers ziyazuza ngokuhambisana okungcono, ukulandeleka, kanye nokusebenza okuphephile kwezokwelapha.

Izitifiketi zibasiza kanjani abathengi ukuthi bagweme izinkinga zochungechunge lokuhlinzeka ngempahla?

Abahlinzeki abaqinisekisiwe banamathuba amancane okubhekana nokuvinjelwa kwemithetho noma ukuhlolwa okuhlulekile. Lokho kusiza imitholampilo nabasabalalisi ukuthi balondoloze ukuthengwa okuzinzile futhi bagweme ukuphazamiseka kokuthunyelwa okungazelelwe noma ukufinyelela emakethe.

Yiziphi izimpawu zekhwalithi ezisebenzayo okufanele ngizihlole ngaphandle kwezitifiketi?

Cela ukulandelelwa kweqoqo, amarekhodi okuhlolwa komkhiqizo, imininingwane yezinto ezibonakalayo, kanye nekhono lemboni. Ku-Denrotary, izibonelo zifaka phakathi ama-workshop ebanga lezokwelapha, imishini yaseJalimane, kanye nemigqa yokukhiqiza ama-bracket ezenzakalelayo.