Impamvu impamyabushobozi za CE, FDA, na ISO ari ingenzi ku batanga serivisi z'amenyo

Intangiriro

Ku batanga serivisi z'amenyo, ikimenyetso cya CE, icyemezo cya FDA, n'icyemezo cya ISO ni ibimenyetso by'ingirakamaro bigaragaza niba ibicuruzwa bishobora kugurishwa, kwizerwa, no gukoreshwa mu buryo bwizewe mu buvuzi. Aya mahame agenga uburyo ibicuruzwa byinjira ku isoko mu Burayi, muri Leta Zunze Ubumwe za Amerika, no mu tundi turere dugenzurwa, mu gihe aha abaguzi ibimenyetso bisobanutse neza by'igenzura ry'inganda, imikorere y'ibicuruzwa, n'iyubahirizwa ry'amategeko. Gusobanukirwa icyo buri cyemezo gihagarariye bifasha abatanga serivisi kugabanya ibyago byemewe n'amategeko n'ubucuruzi, gushimangira icyizere cyo kugura, no guhangana neza n'inganda zibifitiye ubushobozi. Ibice biri hepfo bisobanura uburyo izi mpapuro zigira ingaruka ku cyizere cy'abaguzi, gukwirakwiza ibicuruzwa mu mahanga, no ku mutekano w'igihe kirekire w'ubucuruzi bw'ibicuruzwa by'amenyo.

Impamvu impamyabushobozi za CE, FDA, na ISO ari ingenzi ku batanga serivisi z'amenyo

Isoko ry’ibikoresho by’amenyo ku isi rikora hakurikijwe amategeko akomeye kuko ibi bicuruzwa bigira ingaruka zitaziguyeumutekano w'umurwayiKu batanga serivisi z'amenyo, kubona ikimenyetso cya CE, icyemezo cya FDA, n'ibyemezo bya ISO si urwego rw'ubuyobozi gusa, ahubwo ni ingenzi kugira ngo ubucuruzi bube bwiza. Izi mpapuro z'impamyabumenyi zikora nk'ibipimo ngenderwaho by'ubuziranenge, imikorere myiza, n'umutekano, bigena ubushobozi bw'umutanga serivisi zo gukwirakwiza ibikoresho by'ubuvuzi ku masoko y'ibanze ku isi.

Kugabanya ibyago no kwizera abaguzi

Abahanga mu by'amasoko n'abayobozi b'ubuvuzi bahura n'inshingano zikomeye iyo bashaka ibikoresho by'amenyo n'ibikoresho by'ingenzi. Gukoresha ibikoresho bidafite ishingiro byongera cyane ibyago byo guhura n'ingaruka mbi ku buvuzi, bishobora kwangiza ubukungu n'izina ry'umuntu. Mu gushishikariza abatanga serivisi bafite impamyabushobozi zemewe, abaguzi bagabanya izi ngaruka. Isesengura ry'imibare ry'igenzura nyuma y'isoko ryerekana ko ibigo byemewe na ISO 13485 bihora bifite inenge ziri munsi ya 0.5%, ugereranije n'ibigo bidafite impamyabushobozi aho itandukaniro rishobora kurenza 3% kugeza kuri 5%. Uku kwizerwa kw'abahanga byongera icyizere cy'abaguzi mu gihe kirekire kandi bigatuza imikorere y'uruhererekane rw'ibicuruzwa.

Ibisabwa ku isoko no kubahiriza amategeko

Impamyabushobozi zigena uburyo bwo kugera ku isoko ry’ahantu runaka. Leta Zunze Ubumwe za Amerika zisaba uburenganzira bwa FDA (ubusanzwe ni 510 (k) ku bikoresho byo mu cyiciro cya kabiri), mu gihe Umuryango w’Ubumwe bw’u Burayi utegeka ko habaho ikimenyetso cya CE hakurikijwe amabwiriza akomeye agenga ibikoresho by’ubuvuzi (MDR 2017/745). Hatabayeho izi mpushya, abacuruza amenyo babujijwe n’amategeko gucuruza ibicuruzwa byabo muri utu turere twunguka. Urugero, kutubahiriza MDR yo mu muryango w’ubumwe bw’ibihugu by’uburayi bishobora gutuma isoko ritajya ku isoko ako kanya mu bihugu 27 bigize umuryango, bigahagarika isoko rifite agaciro ka miliyari zisaga 15 z’amayero buri mwaka. Kubera iyo mpamvu, amatsinda ashinzwe gutanga amasoko yiteze ko abatanga ubuvuzi bazakomeza kubahiriza amategeko kugira ngo hirindwe ko imipaka itunguranye y’ibicuruzwa iterwa n’ishyirwa mu bikorwa ry’amategeko.

Icyo impamyabushobozi za CE, FDA, na ISO zisobanura

Gukoresha uburyo bwo kugenzura imiterere y’amenyo bisaba gusobanukirwa neza icyo buri cyemezo bivuze. Nubwo bikunze guhuzwa hamwe, ikimenyetso cya CE, icyemezo cya FDA, n’icyemezo cya ISO bikora imirimo itandukanye y’amategeko n’imikorere mu rwego rw’inganda zikora amenyo.

Kugaragaza CE ugereranije n'icyemezo cya FDA ugereranije n'icyemezo cya ISO

Icyemezo cya ISO, cyane cyane ISO 13485, kigenga Sisitemu yo Gucunga Ubuziranenge (QMS) y'uruganda rukora ibikoresho by'ubuvuzi, kigenzura imiterere, iterambere, n'imikorere ihoraho. Ku rundi ruhande, icyemezo cya FDA n'ikimenyetso cya CE ni uburenganzira bw'isoko ku bicuruzwa byihariye.

Uburyo bwo gushyira ibicuruzwa mu byiciro no kubiha icyemezo

Ibikoresho by'amenyo bishyirwa mu byiciro hakurikijwe ibyago, ari nabyo bigena inzira yo kwemeza. FDA ishyira ibikoresho mu byiciro bya I (ingaruka nke, urugero, uburoso bw'amenyo bukoreshwa n'intoki), Icyiciro cya II (ingaruka ziringaniye, urugero, amatabaza y'amenyo, amatara yo gukangura), na Icyiciro cya III (ingaruka nyinshi, urugero, ibikoresho byo gutera amagufwa). Igikoresho gisanzwe cyo mu cyiciro cya II gisaba kumenyeshwa mbere y'isoko rya 510 (k), bigaragaza ko bingana cyane n'igikoresho cyemewe n'amategeko kandi muri rusange bifata iminsi 90 kugeza 180 kugira ngo kibe cyarasuzumwe. Muri MDR ya EU, ibyiciro bigizwe n'Icyiciro cya I, IIa, IIb, na III. Inzira yo gukoresha igikoresho cyo mu cyiciro cya IIa cyangwa kiri hejuru isaba isuzuma ry'uko ibintu bihuye n'amategeko rikorwa n'Ikigo cyabimenyesheje, inzira ikomeye ishobora kumara amezi 12 kugeza kuri 24 kandi isaba ibimenyetso byinshi by'ubuvuzi.

Itandukaniro ry'ibipimo n'inyandiko

Umutwaro w'inyandiko uratandukanye cyane hagati y'izi nzego. ISO 13485 isaba ibitabo byuzuye bya QMS, inyandiko z'igenzura ry'imbere, n'amabwiriza yo gusuzuma imicungire. Ibisabwa na FDA bisaba inyandiko y'ikoranabuhanga (DMR) n'inyandiko y'amateka y'igishushanyo (DHF). Ikimenyetso cya CE muri MDR gitanga ibisabwa birambuye, harimo gukurikirana nyuma y'isoko (PMCF) na raporo z'ivugurura ry'umutekano (PSUR). Abatanga serivisi bagomba gutanga umutungo uhagije wo kubika izi dosiye za tekiniki; gutsindwa kw'igenzura cyangwa kutagira raporo imwe isabwa y'isuzuma ry'ubuvuzi bishobora gutuma uburenganzira bwo gucuruza buhagarikwa ako kanya.

Uburyo Impamyabumenyi zigira ingaruka ku bwiza bw'umutanga serivisi

Uretse kubahiriza amategeko, gukurikirana no kubungabunga izi mpamyabumenyi bihindura imiterere y'imikorere y'umutanga serivisi. Abatanga serivisi z'ubuvuzi bw'amenyo bemewe bagaragaza umuco wo gukora ibintu, ibyo bikaba bivamo umusaruro mwiza cyane.ireme n'ubwizerweku mukoresha wa nyuma.

Gukurikirana no kugenzura ubuziranenge

Ishingiro rya ISO 13485 na FDA 21 CFR Igice cya 820 ni uburyo bwo gukurikirana kuva ku ntangiriro kugeza ku iherezo. Abatanga serivisi zemewe bashyiraho uburyo buhamye bwo gukurikirana ahantu hatandukanye hamwe na gahunda zihariye zo kumenya ibikoresho (UDI). Ibi byemeza ko buri gikoresho cy'amenyo cyangwa biomaterial bishobora gukurikiranwa nyuma y'ubwoko bw'ibikoresho fatizo byacyo n'impinduka mu buryo bwihariye mu gukora. Mu buryo bufatika, iyo hagaragaye itsinda ry'ibinyabutabire by'amenyo ridafite inenge, umutanga serivisi wemewe ashobora gukora igikorwa cyo gusubiza mu buryo bugamije mu masaha 24 kugeza kuri 48, agatandukanya ahantu hafite ibice 500 aho gusubiza mu buryo butunguranye ibice ibihumbi mirongo. Ibi bigabanya impanuka y'uruhererekane rw'ibikoresho.

Ihindagurika ry'umuvuduko, ikiguzi, n'iyubahirizwa ry'amategeko

Kugera kuri uru rwego rw'igenzura ry'ubuziranenge bitanga impinduka zikenewe hagati y'umuvuduko, ikiguzi, n'iyubahirizwa ry'amategeko. Gushyira mu bikorwa QMS yujuje ibisabwa no kubona icyemezo cya mbere cya ISO 13485 bisaba ishoramari riri hagati ya $20.000 na $50.000. Ibi ntibikubiyemo amafaranga y'igenzura ahoraho buri mwaka cyangwa ikiguzi cyihariye cyo kwandikisha ibicuruzwa bya FDA na CE, bishobora kurenza $100.000 ku bikoresho bigoye byo mu cyiciro cya IIb cyangwa III. Kubera iyo mpamvu, abatanga ibikoresho bemewe akenshi baba bafite ibiciro biri hejuru bya Minimum Order Quantities (MOQs) cyangwa ibiciro bya buri kimwe ugereranije n'abanywanyi badafite impamyabushobozi ku isoko ryigenga. Ariko, abaguzi bagabanya ibi biciro by'ubwishyu mbere y'igihe birinda ibiciro byihishe by'ibiciro biri hejuru by'inenge, kwangwa kw'ibicuruzwa muri gasutamo, n'imyenda ishobora kuba mibi.

Ibipimo by'ingenzi mu isuzuma ry'umuguzi

Mu gusuzuma abashobora gutanga serivisi z'amenyo, amakipe ashinzwe gutanga amasoko agomba kureba kure y’aho hari icyemezo gusa. Ibipimo by'ingenzi by'isuzuma bigomba kuba birimo uburyo bwo gukosora no gukumira indwara (CAPA) bw'umutanga serivisi, igihe yafashe mu mateka ku bijyanye no kudakurikiza ireme ry'ubuvuzi, hamwe n'igihe cy'igenzura ry'imbere mu kigo. Umutanga serivisi akoresha neza uburyo bwe bwa CAPA kugira ngo akomeze kunoza imikorere—bigaragazwa no kugabanuka gushoboka kw'ibirego by'abakiriya mu gihe cy'amezi 12—agaragaza umuco wo gukura w'ubwiza urenze ibisabwa n'amategeko y'ibanze.

Uburyo abaguzi bagomba kwemeza ibirego by'impamyabushobozi

Kuba hari ibyemezo by’uburiganya cyangwa ibyarangiye mu nganda ku isi bisaba gukora ubushakashatsi bwimbitse. Abahanga mu by’amasoko ntibashobora kwemera inyandiko uko zisanzwe zitangwa; kugenzura neza ni ngombwa kugira ngo uruhererekane rw’ibicuruzwa by’amenyo rurindwe.

Inyandiko zo gusaba abatanga serivisi

Kwandika umutanga serivisi ku nshuro ya mbere bigomba kuba birimo ubusabe bwemewe bw’amategeko bwo gusaba inyandiko zihariye z’amategeko. Abaguzi bagomba gusaba icyemezo cya ISO 13485 kiriho ubu, Itangazo ry’Ubumwe bw’u Burayi ryo Gukurikiza Amategeko (DoC), Kwandika FDA, n’ibaruwa yihariye yo kwemerera ibikoresho by’ingenzi 510 (k). Byongeye kandi, gusaba raporo y’incamake iheruka gutangwa n’igenzura rya Notified Body cyangwa Raporo y’Ubugenzuzi bw’Ikigo cya FDA (EIR) bitanga ubumenyi bwimbitse ku bijyanye n’uko umutanga serivisi akomeje kubahiriza amategeko ndetse n’uko ibintu biherutse kutubahirizwa.

Uburyo bwo kwemeza kwiyandikisha n'ibyemezo

Kugira inyandiko ntibihagije; ukuri kwayo kugomba kwemezwa ku buryo bwigenga binyuze mu nzira zemewe.

Abaguzi bagomba kwandika izina nyaryo ry’ikigo n’aderesi y’inganda zikora ibicuruzwa ku cyemezo hamwe n’ububiko bw’amakuru bwemewe. Ibitandukanye—nk’icyemezo gihabwa ikigo cy’ababyeyi ariko atari ikigo cyihariye gikora intebe z’amenyo—bigaragaza ko amategeko yubahirizwa.

Uburyo bwo gukora igenzura rifatika

Uburyo bwo gukora igenzura rifatika bugomba gukurikiza uburyo bufite gahunda kandi bugizwe n'ibice byinshi. Ubwa mbere, gukora igenzura ry'ibanze rya elegitoroniki ukoresheje ububiko bwa interineti bwa leta. Ibi akenshi bifata amasaha ari munsi ya 48 ariko bishobora guhita bishungura abacuruzi b'abatekamutwe. Icya kabiri, kugenzura urwego; menya neza ko icyemezo cya ISO 13485 gikubiyemo "ibikoresho by'amenyo"cyangwa" ibikoresho byo gutunganya ibyuma bisanzwe. Hanyuma, tegeka ko habaho igenzura ry’umuntu wa gatatu mbere yo kurangiza amasezerano arenze urugero rw’imari rwagenwe, nka $50.000 mu mafaranga akoreshwa buri mwaka. Iri genzura rifatika ryemeza ko QMS ivugwa mu nyandiko ikorerwa mu ruganda.

Uburyo bwo gufata ibyemezo byiza byo kwemeza no gushakisha isoko

Kunoza uruhererekane rw'ibicuruzwa by'amenyo bisaba guhuza ingamba hagati y'imiterere y'ibyago by'ibicuruzwa, ibisabwa n'amategeko, n'intego z'amasoko. Abaguzi bagomba gushyiraho uburyo bwo gushakisha amasoko bukoresha ibyemezo nk'igikoresho cyo guhanga agaciro aho kubibona nk'imbogamizi z'ubuyobozi gusa.

Gushyira imbere ishoramari mu gutanga impamyabushobozi

Amashyirahamwe agomba gushyira imbere ibisabwa mu gutanga icyemezo hashingiwe ku byiciro by'ibikoresho n'ikoreshwa ryabyo mu buvuzi. Ku bikoresho byo mu cyiciro cya mbere bidasukuye, nk'indorerwamo z'ibanze zo gusuzuma, gushimangira icyemezo cy'ingenzi cya CE MDR gitangwa n'Ikigo cya Notified Body cyo mu rwego rwo hejuru bishobora kongera ikiguzi bitari ngombwa. Ku rundi ruhande, ku bikoresho bishobora gushyirwa mu cyiciro cya gatatu, kubangamira ibyangombwa bya FDA cyangwa CE ntibishobora kuganirwaho. Amatsinda ashinzwe gutanga amasoko agomba gutegeka ISO 13485 nk'amahame shingiro ku 100% by'abatanga ibikoresho by'ingenzi, bigatuma habaho urwego rw'ibanze rwaimicungire myizamu buryo bwose bw'ubucuruzi mbere yo gusuzuma uburenganzira bw'ibicuruzwa byihariye.

Kunoza uburyo bwo kubahiriza amategeko, ikiguzi, n'ingaruka zo gutanga ibicuruzwa

Kunganya ubwuzuzanye, ikiguzi, n'ingaruka zo gutanga ibicuruzwa bikubiyemo gushyiraho ingamba z'umutanga serivisi mu byiciro bitandukanye. Kwishingikiriza ku mutanga serivisi umwe wemewe cyane mu rwego rwo hejuru bigabanya ibyago byo kubahiriza amategeko ariko byongera ikiguzi n'ingaruka zo kwangirika kw'ibintu mu gace runaka. Ku rundi ruhande, gushaka ibikoresho mu turere duhendutse gusa tudakoresheje ibyemezo bikomeye biteza ibibazo bikomeye mu mategeko no mu bwiza. Uburyo buringaniye bushobora gutanga 70% kugeza kuri 80% by'ingano y'ibikoresho by'ingenzi by'amenyo ku batanga serivisi z'ibanze bemewe kandi bemewe (FDA / CE / ISO), mu gihe hatezwa imbere abatanga serivisi ba kabiri bafite ISO 13485 kandi bashora imari mu nzira za FDA / CE. Iyi ngamba itanga inyungu ku giciro no kugabanya umubare w'abatanga serivisi mu gihe hagumaho urwego ruhamye rw'ibyago byemewe mu buvuzi.

Ibintu by'ingenzi byakunzwe

• Imyanzuro y'ingenzi n'impamvu z'ingenzi ku batanga serivisi z'ubuvuzi bw'amenyo
• Ibisobanuro, kubahiriza amategeko, n'igenzura ry'ingaruka bikwiye kwemezwa mbere yo kwiyemeza
• Intambwe zikurikiraho zifatika n'ibyo abasomyi bashobora gushyira mu bikorwa ako kanya

Ibibazo Bikunze Kubazwa

Kuki nahitamo umucuruzi wemewe na CE, FDA, na ISO13485 wo kuvura indwara z'amenyo?

Izi mpamyabumenyi zigaragaza ko utanga ibicuruzwa yujuje ibisabwa mu mutekano, ubuziranenge, no kubahiriza amategeko, bigabanya ingaruka z’ibicuruzwa kandi bigafasha mu kwemeza ko ibicuruzwa byemerewe kugurishwa mu masoko akomeye nka EU na Amerika.

Ese Denrotary ifite icyemezo cy’uko ivuriro ry’amenyo ku isi ritanga imiti ku rwego rw’isi?

Yego. Denrotary ivuga ko ifite icyemezo cya CE, FDA, na ISO13485, gishyigikira inganda zigenzurwa n’ubuziranenge ndetse n’ubufatanye mpuzamahanga bunoze.

Ni ibihe bicuruzwa bya Denrotary bifitiye akamaro cyane mu nganda zemewe?

Ibintu by'ingenzi byo kuvura amenyo nk'udupfunyika twigenga, imiyoboro ya buccal, insinga za arch, iminyururu y'amashanyarazi, na pliers bigira akamaro mu kunoza imikorere, gukurikirana neza no gukora neza mu buvuzi.

Ni gute ibyemezo bifasha abaguzi kwirinda ibibazo by'uruhererekane rw'ibicuruzwa?

Abatanga ibicuruzwa bemewe ntibakunze guhura n’ibibazo by’amategeko cyangwa igenzura ryakozwe nabi. Ibyo bifasha amavuriro n’abacuruza ibicuruzwa kugumana uburyo buhamye bwo kubishakira ibicuruzwa no kwirinda ko ibicuruzwa bijyanwa mu mahanga cyangwa kohereza ibicuruzwa mu buryo butunguranye.

Ni ibihe bimenyetso by'ubuziranenge nkwiye kugenzura uretse impamyabumenyi?

Saba uburyo bwo gukurikirana ibintu mu buryo butandukanye, inyandiko z'ibizamini by'ibicuruzwa, ibisobanuro birambuye ku bikoresho, n'ubushobozi bw'uruganda. Kuri Denrotary, ingero zirimo amahugurwa yo mu rwego rw'ubuvuzi, ibikoresho by'Abadage, n'imirongo ikora ibyuma byikora.