Intsinzi ya Jortech Intsinzi: Icyemezo cya MDR & FDA kumurongo wuzuye wibicuruzwa

Hamwe no kwiyongera kwimibanire yibikoresho byubuvuzi byigihugu, amasosiyete yo mumahanga yinjiza amasoko yuburayi na Amerika agomba kuba afite ubushobozi bwo kugurishwa mbere yisoko (nta bugenzuzi bwo kugenzura) na Surveillance (PMS). Hariho itandukaniro rikomeye muburyo bwo kugenzura, kugenzura no guhana hagati ya Amerika na EU MDR / IVDR.

Niki FDA nubuyobozi bwibiyobyabwenge byo muri Amerika) ?
FDA igenga umutekano no gukora neza ibikoresho byubuvuzi muri Amerika. Kubikoresho byinshi, abakora bagomba gutanga 510 (k) kugirango bagaragaze ko ibicuruzwa byabo bifite umutekano, bifatika, kandi bihwanye cyane nibikoresho byemewe.

Niki MDR (amabwiriza yibikoresho byubuvuzi) ?
MDR ni amabwiriza yubumwe yuburayi kubikoresho byubuvuzi, asimbuza uwahoze ari mdd (amabwiriza yubuvuzi). Ifite ibisabwa mu gusuzuma kuvura amavuriro, kugenzura nyuma yisoko, na dosiye ya tekiniki kugirango umutekano wiremwe wiremwe wiremwe wiremwe wiremwe wiremwe.

Kuyobora FDA na MDR biragoye - ariko biranenga. Muri Joytech, twubatse sisitemu yo kubahiriza isi yose kugirango ifashe abafatanyabikorwa mu bucuruzi bujuje ibyo amahame asaba. Waba urimo wagutse muri Amerika cyangwa winjiye muri EU munsi ya MDR, ibicuruzwa byacu byemejwe, ibyangombwa bya tekiniki, hamwe nubuhanga bwo kugenzura biri hano kugushyigikira.

W ingofero w e h ave?

Muri Joytech, twashinze urufatiro rukomeye rwo guha imbaraga abafatanyabikorwa bacu ku isi. Joytech yubatse urwego rwuzuye kandi rwo kubahiriza imbere ruterana ibisabwa ku isi ku masoko makuru.

FDA 510 (K)

Joytech yamaze igihe kinini ashyiraho isoko rikomeye mu isoko rya Amerika, hamwe n'imirongo yacu y'ibicuruzwa bimaze guhanaga kandi bitangwa cyane ku bafatanyabikorwa ku isi. Inyubako kuri iri shingiro ryemejwe, dukomeza gushora imari mumico yimico nubugenzuzi kugirango duhuze ibikenewe byubuvuzi hamwe nabafatanyabikorwa.

Muri 2025, twagutse FDA Portfolio hamwe nimpamyabumenyi nshya:

• Umuyoboro wo hejuru wo hejuru wamaraso umuvuduko ukurikirana - Gutanga ibicuruzwa byayongereye hamwe nubunararibonye bwabakoresha.

• Ikinini-cya digitale BP Monitors (DBP-6186 / 6286B) - Yateguwe kungano zagutse (40-56 cm), hamwe namahitamo ya Bluetooth.

• Compressor Nebulizers (NB-1100 kuri NB-1103) - FDA-Yakuweho muri Kode y'ibicuruzwa Caf, ishyigikira kuvura ubuhumekero bwizewe murugo cyangwa mumavuriro.

EU MDR Icyemezo

Joytech ari mubakora abakora abashinwa kugirango bagere kubyemezo bya EU MDR munsi yamategeko mashya. Muri Mata 2022 , twakiriye icyemezo cyacu cya mbere cya Tüv Süd, gitwikiriye ibicuruzwa nka thermometero za MDR mu byiciro byinshi mu byiciro byinshi mu gishinwa mu byiciro byinshi birimo ibikoresho bya elegitoroniki na pompe.

Kuva icyo gihe, twakomeje kwagura ibyangombwa bya MDR byemewe buri mwaka. Kugeza 20 Ukwakira3 , abantu bose bashya b'amaraso akurikirana na TranRometers bahawe IC (MDR). Kuva 2025 , icyiciro cya kane cyibicuruzwa byemewe birimo:

• zose Nebulizers

• ECG Umuvuduko wamaraso ukurikirana

• Ibimenyetso by'ingenzi Abikurikirana

• Ibikoresho byose bya bluetooth-bifasha

• Pompe zose

Uku kwaguka guhoraho byerekana ubwitange bwimbitse bwo kubahiriza, guhanga udushya, no kugenzura neza. Ibicuruzwa byacu byuzuye ubuzima, kwipimisha, inganda, inyandiko, hamwe no kugenzura nyuma yamasoko, bituma abafatanyabikorwa bacu bakomeye, baha imbaraga ibisubizo byemewe, byiteguye-byiterambere muri EU.

Ibindi bipimo ngenderwaho

Inzira zacu zo gutunganya zemejwe munsi ya ISO 13485 na MDSAP , zisaba ibyifuzo ngenzugiri bya Amerika, Kanada, Ositaraliya, Ubuyapani, na Berezile.

Nanone, ibicuruzwa bya Joytech nabo bihuye na NMPA (Ubushinwa), Rohs, no kugera ku mabwiriza, ibipimo by'Ibidukikije, n'ibipimo ngenderwaho muri Aziya na EU.

Icyo bivuze kubafatanyabikorwa bacu？

Gukorana na Joytech ntibisobanura ibirenze gukuramo ibicuruzwa - bisobanura kubona umufasha ufatika wumva abantu benshi bubahiriza.

v Ingaruka zishinzwe kugenzura nibiciro - Impamyabumenyi yacu yiteguye-kugenda kandi uburambe bwisi yose igabanya umutwaro kubikorwa byo kwiyandikisha.

VUTI yihuta - hamwe nibikoresho byiyemeje, urashobora gutangiza mukarere kawe hamwe numuvuduko mwinshi no gutinda bike.

v Inkunga ya tekiniki ya tekiniki na kavukire - kuva inyandiko za tekiniki kumavukire, itsinda ryacu ryinzu ritanga inkunga ihujwe no guhura nibisabwa byigihugu.

v Kugaragaza ubwiza nubugenzuzi bwa sisitemu yacu ifite ubugenzuzi bwinshi bwabandi, kandi inyandiko zacu zihora zibikwa ubugenzuzi-ubugenzuzi, iremeza gukorera mu mucyo no gukora neza.

Guhuriza hamwe:
Nkamabwiriza arahinduka, natwe tuzabikora. Joytech yiyemeje gukomeza kwagura umurongo wacyo ku isi hose na FDA na MDR - bahura n'abafatanyabikorwa bacu bashishikajwe no kubona ibikoresho byemewe, bifite ireme mu masoko yemewe.

Tumaze gukora impamyabumenyi mu turere twinshi ku isi, harimo na Amerika y'Amajyaruguru, EU, Aziya, ndetse no hanze yarwo.

Urashaka kumenya niba twemejwe ku isoko ryawe?

Gushakisha Augelatory-Deem Deem / Igisubizo cya Odm?

Ihuze nitsinda ryacu uyumunsi kugirango dushakishe ibisobanuro byicyemezo amakuru, ibyangombwa bya tekiniki, hamwe nibisubizo bihujwe kumushinga wawe. Hamwe na Joytech, kubahiriza bihinduka inyungu zawe zo guhatana.