Ngā Kaiwhakarato Whītiki Whītiki 10 kua Tiwhiketetia e te CE i Ūropi (2025 Whakahōungia)

He mea nui te whiriwhiri i te kaiwhakarato taputapu tiaki niho tika mō ngā mahi tiaki niho i Ūropi. Mā te tiwhikete CE ka tutuki i ngā ture pakari a te EU, ka whakarite i te haumaru me te kounga o te hua.Ko ngā anga ture pēnei i te EU MDR e hiahia ana kia whakatikatikahia e ngā kaihanga ngā pūnaha whakahaere kounga.me te whakarei ake i ngā tukanga whakamātautau hua. Mā ēnei mahi ka tutuki i ngā kaiwhakarato tiaki niho o te EU ngā paerewa teitei, ka tiakina ngā hua o te tūroro. Mēnā kāore e tutuki ngā whakaritenga, ka tūpono te ngaronga pūtea me te kino o te ingoa pai, ā, he mea nui te piri ki ngā ture. E whakaatu ana tēnei whakahoutanga o te tau 2025 i ngā kaiwhakarato e tino pai ana ki te kounga, te auahatanga, me te makona o te kiritaki, e tuku ana i ngā otinga pono mō ngā tohunga tiaki niho.

Ngā Whakaaro Matua

• E whakaatu ana te tiwhikete CE e tutuki ana ngā ārai niho i ngā ture haumaru me te kounga o te EU.
• Mā te whiriwhiri i ngā kaiwhakarato he maha ā rātou hua ka āwhina i te whakatutuki i ngā matea rerekē o ngā tūroro.
• Ka whakatupu whakawhirinaki te kaiwhakarato i ngā arotake pai a te kaiwhakarato, ā, ka pā hoki ki ngā whiringa hoko.
• Mā te tautoko a ngā kaiwhakarato ka māmā ake te mahi, ka hanga hoki i te whakawhirinaki.
• Ngā hangarau hou, pērā i te tānga 3Dme te AI, ka pai ake ngā maimoatanga.
• Mā ngā arowhai auau me te ISO 13485:2016 ka kaha tonu ngā pūnaha kounga.
• Mā te tirotiro i te huarahi e whakahaerehia ai e ngā kaiwhakarato ngā raruraru ka whakarite kia pai te ratonga me ngā whakatikatika.
• Mā te mahi tahi me ngā kaiwhakarato pono ka hua ake te kounga pumau me te tiaki pai ake.

Ngā Paearu mō te Kōwhiri i ngā Kaiwhakarato Orthodontic Pai rawa atu o te EU

Tiwhikete CE me te Whakatutukitanga

He mea nui te tiwhikete CE hei whakarite i te haumaru me te kounga o ngā hua orthodontic i Ūropi. Me piri ngā kaiwhakarato ki ngā paerewa ture pakari, pērā i te EU Medical Device Regulation (EU MDR), e whakahau ana i ngā aromatawai haumanu, te whakahaere mōrearea, me te tirotiro i muri i te mākete.Ka whakapakari ake te ISO 13485:2016 i te tutuki i ngā whakaritengamā te whakatū i ngā pūnaha whakahaere kounga kua whakaritea mō ngā taputapu hauora.

Ngā hua tiaki niho, e whakarōpūtia ana hei taputapu hauora Akomanga IIa, me whai whakapuakitanga tutuki i raro i te mana o ngā whakaritenga e tautokona ana e ngā aromatawai mai i ngā rōpū whakamōhiotia. Ka whakatauritehia e tēnei tukanga te auahatanga me te haumaru o te tūroro.Ehara i te mea ko te tohu CE anake te whakamana i te piripono ki te haumaru o te EU, hauora, me ngā paerewa taiao engari ka whakarei ake hoki i te whakawhirinaki o ngā kaihoko. Ka whakaitihia ngā mōrearea nama mō ngā kaihanga, ka tiaki i a rātou mai i ngā kereme pea e pā ana ki te haumaru o ngā hua.

Kounga me te whānuitanga o ngā hua

He nui te pānga o te momo me te kounga o ngā hua e tukuna ana e ngā kaiwhakarato tiaki niho o te EU ki tā rātou whiringa. Ka whakatinanahia e ngā kaiwhakarato matua ngā tikanga whakamātautau pakari hei tautuhi wawe i ngā hapa, hei whakarite i te pono me te tiaki i ngā putanga o ngā tūroro.Te tutuki i ngā tiwhikete pēnei i te EU MDR me te ISO 13485:2016e whakarite ana kia tutuki ngā hua i ngā paerewa haumaru me te kounga o te ao.

Ka pupuri hoki ngā kaiwhakarato i ngā tuhinga taipitopito o ngā mehua whakahaere kounga, e whakaatu ana i tā rātou whakapau kaha ki te hiranga. Mā ngā arotake me ngā tirotiro auau ka whakamanahia anō tā rātou piri ki ngā paerewa teitei. Mā te whānuitanga o ngā hua, me te kounga pumau, ka taea e ngā tohunga whakatikatika niho te whakatutuki i ngā hiahia kanorau o ngā tūroro.

Rongonui me ngā Arotake a te Kaihoko

Ko te ingoa o te kaiwhakarato e whakaata ana i tōna pono me te kounga o te ratonga. Ko ngā arotake me ngā whakaaturanga kua manatokohia mai i ngā tohunga whakatikatika niho me ngā tūroro e whakarato ana i ngā māramatanga whai hua mō te mahi a te hua me te pai o te kiritaki. E whakaatu ana ngā tatauranga he nui ake te tūponotanga o te 72% o ngā kiritaki ki te hoko mai i ngā kamupene he pai ngā arotake, ko te 70% o ngā kiritaki pono e taunaki ana i ngā waitohu ki ētahi atu.

He mea nui te wheako o te kiritaki ki te hanga i te ingoa o te kaiwhakarato. Ko ngā kamupene e tere ana te whakatau i ngā amuamu ka pupuri i te 80% o ā rātou kiritaki, ā, ko te hunga e tuku ana i ngā wheako whaiaro ka kite i ngā reiti pono teitei ake. Ko ngā kaiwhakarato me te ratonga kiritaki pai me ngā rauemi whakangungu he maha ngā wā ka eke ki ngā Kaute Whakatairanga Kupenga (NPS) teitei ake, e tohu ana i te kaha ake o te tautoko kiritaki.

Auahatanga me te Hangarau

Kua hurihia e te auahatanga hangarau te umanga tiaki niho, ā, kua taea e ngā kaiwhakarato te tuku otinga matatau hei whakarei ake i te tiaki tūroro me te whakahaere i ngā mahi. Kei te whakamahi ngā kaiwhakarato tiaki niho matua o te EU i ngā hangarau matatau hei whakapai ake i te whai huatanga o te hua, te whakaritenga, me te tika.

• Kua puta te hangarau tā 3D hei huringa nui i roto i te mahi orthodontics. Mā tēnei ka taea te tere ake te hanga i ngā whakarārangi me ngā whāriki mārama, me te tuku i ngā whakaritenga kua whakarei ake kia rite ki ngā hiahia takitahi o te tūroro. Ehara i te mea ka whakapai ake tēnei auaha i te whakamarie o te tūroro engari ka whakaiti hoki i te wā maimoatanga.
• Kei te hurihia e ngā pūnaha tātaritanga me te whakamahere maimoatanga e te AI te huarahi e whakatata atu ai ngā tākuta niho ki te tiaki tūroro. Ka tātarihia e ēnei pūnaha ngā raraunga hei waihanga i ngā mahere maimoatanga tika, kia pai ake ai ngā putanga me te whakaiti i ngā hapa.
• Kei te whakarei ake ngā taputapu matawai matihiko me ngā taputapu niho atamai i te wheako o te tūroro. Ka whakapai ake ēnei taputapu i te tika o te whakaurunga, ā, ka whakaiti i te hiahia mō ngā whakatikatika ā-ringa, ka pai ake te mahi a ngā tikanga, ā, ka iti ake te whakaekenga.

I roto i tētahi tuhinga o Pēpuere 2024, e whakamārama ana i te mahi a te AI ki te whakapai ake i te whakamahere maimoatanga, ā, i roto i tētahi pūrongo o Hānuere 2024, e whakamārama ana i te whai huatanga o te tānga 3D i roto i te hanga whakarārangi niho mārama. E whakaatu ana ēnei whanaketanga i te hiranga o te auahatanga ki te pupuri i ngā paerewa teitei i roto i te umanga orthodontic.

Tautoko Kaihoko me te Ratonga Whai Muri i te Hoko

Ko te tautoko kiritaki tino pai me te ratonga muri-hoko he mea nui e wehewehe ana i ngā kaiwhakarato tiaki niho matua o te EU. Ko ngā kamupene e whakatairanga ana i te pai o te kiritaki ka hanga hononga roa, ka poipoi hoki i te whakawhirinaki i waenga i ā rātou kiritaki. Mā ngā pūnaha tautoko whai hua ka taea e ngā tohunga tiaki niho te whakawhirinaki ki ā rātou kaiwhakarato mō te āwhina, te whakangungu, me te whakatau take.

Ka whakamanahia e ngā inenga mahi matua te whai huatanga o ngā ratonga tautoko kiritaki:

Ko ngā kaiwhakarato me ngā kaute CSAT me NPS teitei e whakaatu ana i tā rātou whakapau kaha ki ngā mahi e aro ana ki te kiritaki. Mā te ratonga whai muri i te hoko, pērā i te whakatau tere i ngā take me ngā rauemi whakangungu e wātea ana, ka taea e ngā tākuta niho te arotahi ki te whakarato tiaki kounga ki ā rātou tūroro. Mā te haumi ki ngā pūnaha tautoko pakari, ka whakapakarihia e ngā kaiwhakarato tō rātou ingoa rongonui me te whakatipu i te pono i roto i te hapori niho.

Ngā Kaiwhakarato Whītiki Whītiki 10 kua Tiwhiketetia e te CE i Ūropi

Kaiwhakarato 1: Hangarau Whakahāngai

Tirohanga Whānui o te Kamupene

Ko Align Technology, he kaiārahi o te ao i roto i te mahi whakatikatika niho, he tohunga ki ngā otinga auaha mō ngā tohunga niho. I whakatūria i te tau 1997, kei Tempe, Arizona te tari matua o te kamupene, ā, he kaha tōna aroaro ki Ūropi. E mōhiotia whānuitia ana a Align Technology mō tana pūnaha Invisalign, kua huri i te maimoatanga whakatikatika niho puta noa i te ao. Kei te whakahaerehia te kamupene i roto i te neke atu i te 100 whenua, e tuku ana i ngā hua hou e whakatairanga ana i te whakamarie me te whai hua o ngā tūroro.

Ngā Hua me ngā Āhuatanga Matua

Ko te hua matua a Align Technology, arā, ko Invisalign, he whakarārangi niho mārama kua hangaia mō te whakatikatika niho huna, whai hua hoki. Ka whakamahia e ēnei whakarārangi niho ngā rauemi SmartTrack, kia pai ai te noho me te whakamarie. Kei te kamupene hoki te matawai ā-waha iTero, e whakarei ake ana i te tika o te maimoatanga mā roto i ngā tānga matihiko tika. Ka hono pai ngā hua a Align Technology ki ngā taputapu whakamahere maimoatanga e whakamahia ana e te AI, kia taea ai e ngā tākuta niho te whakarato i te tiaki whaiaro.

Ngā Tiwhikete me ngā Whakatutukitanga

E piri ana a Align Technology ki ngā paerewa ture tino pakari, tae atu ki te tiwhikete CE me te tutuki i ngā whakaritenga ISO 13485:2016. Mā ēnei tiwhikete ka whakamanahia te haumaru me te kounga o āna hua, ka tutuki hoki i ngā whakaritenga o te EU Medical Device Regulation (EU MDR). Ka whakahaerehia e te kamupene he whakamātautau tino pakari, ā, ka pupuri i ngā tuhinga taipitopito hei whakarite kia tutuki i ngā paerewa o te ao.

Ngā Tohu Hokonga Ahurei

E tū pakari ana a Align Technology mō tōna whakapau kaha ki te auahatanga me ngā otinga e aro ana ki te tūroro. He huarahi kē atu e kore e kitea i roto i tana pūnaha Invisalign, he mea e kukume ana i ngā tūroro e rapu ana i ngā kōwhiringa ataahua. Mā te whakaurunga o te hangarau matawai AI me te mamati ka whakarei ake i te tika o te maimoatanga, ka whakaiti i te wā tūru mō ngā tākuta niho. Mā te whānuitanga o te ao me te whatunga tautoko pakari a Align Technology ka whakaū ake i tōna tūranga hei hoa pono mō ngā tohunga niho.

Kaiwhakarato 2: Ormco

Tirohanga Whānui o te Kamupene

Ko Ormco, he paionia i roto i te mahi whakatikatika niho, kua neke atu i te 60 tau e mahi ana ki ngā tohunga niho. Kei Orange, California te tari matua o te kamupene, ā, kei te ao katoa ia e mahi ana, tae atu ki tētahi aroaro nui ki Ūropi. Ko te arotahi a Ormco ki te whakawhanake i ngā hua auaha e whakangāwari ana i ngā tikanga whakatikatika niho me te whakapai ake i ngā putanga o ngā tūroro.

Ngā Hua me ngā Āhuatanga Matua

Kei roto i te kohinga hua a Ormco te Damon System, he pūnaha whāriki here-whaiaro e whakaiti ana i te waku me te whakarei ake i te whakamarie o te tūroro. Kei te tuku hoki te kamupene i te Insignia, he otinga orthodontic mamati ritenga e whakakotahi ana i te whakaahua 3D me te whakatakotoranga whāriki tika. Kua hangaia ngā hua a Ormco hei whakahaere i ngā reremahi me te whakaputa hua e taea te matapae.

Ngā Tiwhikete me ngā Whakatutukitanga

E tutuki ana a Ormco i ngā whakaritenga tiwhikete CE me ngā paerewa ISO 13485:2016, e whakarite ana i te haumaru me te pono o āna hua. E whai ana te kamupene i ngā tikanga whakahaere kounga pakari, ā, e whakahaere ana i ngā arotake auau hei pupuri i te tutuki i ngā ture MDR a te EU.

Ngā Tohu Hokonga Ahurei

Ka hurihia e te Pūnaha Damon a Ormco te maimoatanga niho mā te whakakore i te hiahia mō ngā here rapa, te whakaiti i te wā maimoatanga me te kore whakamarie. Ka tukuna e te pūnaha Insignia he huarahi kua whakaritea katoatia, ka taea ai e ngā tākuta niho te whakatutuki i ngā hua tika e tika ana mō ia tūroro. Nā te whakapau kaha o Ormco ki te auahatanga me te tautoko kiritaki, he mea pai tēnei i waenga i ngā kaiwhakarato niho o te EU.

Kaiwhakarato 3: 3M

Tirohanga Whānui o te Kamupene

He kamupene ao whānui a 3M, ā, kua roa nei ia e mōhiotia ana mō tōna hiranga i roto i ngā momo ahumahi, tae atu ki te tiaki niho. Kei St. Paul, Minnesota tōna tari matua, ā, e mahi ana a 3M ki ngā kiritaki puta noa i te ao me te arotahi nui ki te rangahau me te whanaketanga. He whānuitanga o ngā hua e tukuna ana e te wehenga tiaki niho a te kamupene kua hangaia hei whakarei ake i te whai huatanga o te maimoatanga me te makona o te tūroro.

Ngā Hua me ngā Āhuatanga Matua

Ka whakakotahi ngā Brackets Ceramic Clarity Advanced a 3M i te ataahua me te pakari, ka whakarato i tētahi kōwhiringa huna mō ngā tūroro. Kei te tuku hoki te kamupene i ngā Brackets Self-Ligating Unitek Gemini SL, e whakaiti ana i te waku me te whakapai ake i te whai huatanga o te maimoatanga. Hei tāpiri, ka whakangawari te Pūnaha Piripiri Kore-Uira APC a 3M i te herenga o ngā bracket, ka penapena i te wā mō ngā tākuta niho.

Ngā Tiwhikete me ngā Whakatutukitanga

E tutuki ana ngā hua whakatikatika niho a 3M i ngā paerewa tiwhikete CE, ā, e tutuki ana hoki i ngā whakaritenga ISO 13485:2016. He maha ngā whakamātautau me ngā tukanga whakapūmau kounga e whakahaerehia ana e te kamupene hei whakarite kia rite ana hua ki ngā ture MDR a te EU.

Ngā Tohu Hokonga Ahurei

He tino pai te mahi a 3M ki te whakakotahi i te auahatanga me te mahi whaihua. Ka tukuna e āna Clarity Advanced Ceramic Brackets he ranunga o te ataahua me te mahi, e kukume ana i ngā tūroro e rapu ana i ngā whiringa maimoatanga huna. Ka whakarei ake te Pūnaha Piripiri Kore-Uira APC i te pai o te rere o ngā mahi, ka taea ai e ngā tākuta niho te aro ki te tiaki tūroro. Ko te whakapau kaha a 3M ki te kounga me te auahatanga ka whakaū i tōna tūranga hei kaiārahi i roto i te umanga niho.

Kaiwhakarato 4: American Orthodontics

Tirohanga Whānui o te Kamupene

I whakatūria a American Orthodontics i te tau 1968, ko tētahi o ngā kaihanga niho motuhake nui rawa atu o te ao. Kei Sheboygan, Wisconsin te tari matua o te kamupene, ā, kei te ao whānui, tae atu ki tētahi tūranga pakari i Ūropi. Ko tana arotahi ko te whakarato i ngā hua niho kounga teitei e tutuki ai ngā hiahia o ngā tohunga niho me ngā tūroro.

Ngā Hua me ngā Āhuatanga Matua

He whānuitanga o ngā hua a American Orthodontics, tae atu ki ngā whāriki, ngā waea, me ngā taura whakapūmau. He mea rongonui ngā Empower® Brackets, he hoahoa here-ā-unoa e whakaiti ana i te waku me te whakarei ake i te whakamarie o te tūroro. Kei te whakarato hoki te kamupene i ngā Radiance Plus® Ceramic Brackets, e mōhiotia ana mō tōna ataahua me te pakari. Hei tāpiri, mā ōna NiTi Archwires ka whakarite kia rite tonu te kaha o te whakamahi, ka whakapai ake i te whai huatanga o te maimoatanga.

Ngā Tiwhikete me ngā Whakatutukitanga

E piri ana te kamupene ki ngā paerewa ture tino pakari, tae atu ki te tiwhikete CE me te tutuki i ngā whakaritenga ISO 13485:2016. Mā ēnei tiwhikete ka whakaūtia e tutuki ana i āna hua ngā whakaritenga haumaru me te kounga kua whakatakotoria e te EU Medical Device Regulation (EU MDR). Ka whakahaerehia e American Orthodontics ngā arotakenga auau me ngā whakamātautau pakari hei pupuri i ēnei paerewa teitei.

Ngā Tohu Hokonga Ahurei

E tū pakari ana a American Orthodontics mō tōna whakapau kaha ki te auahatanga me te makona o ngā kiritaki. Mā ōna Empower® Brackets ka māmā ake te tukanga whakatikatika niho, ka whakaitihia te wā tūru mō ngā kaimahi. Ka tukuna e ngā Radiance Plus® Ceramic Brackets he kōwhiringa huna mō ngā tūroro e rapu ana i ngā otinga ataahua. Nā te whakapau kaha o te kamupene ki te kounga me te whānuitanga o ngā hua ka waiho hei hoa pono mō ngā tohunga whakatikatika niho puta noa i te ao.

Kaiwhakarato 5: Denrotary Medical

Tirohanga Whānui o te Kamupene

I whakatūria a Denrotary Medical i te tau 2012, ā, he kaiwhakarato matua ia mō ngā hua tiaki niho. Kei Ningbo, Zhejiang, Haina tōna turanga, ā, kua rongonui te kamupene mō te kounga me te pono. Ka mahi tahi me ngā umanga o te ao, tae atu ki ērā i Ūropi, ki te whakarato i ngā otinga auaha mō te tiaki niho.

Ngā Hua me ngā Āhuatanga Matua

He tohunga a Denrotary Medical ki ngā whāriki tiaki niho, ngā waea, me ngā taputapu. Ka hangaia e āna raina whakaputa matatau tae atu ki te 10,000 whāriki ia wiki, kia mau tonu ai te tuku. Ka whakamahia e te kamupene ngā taputapu hou o Tiamana hei whakaputa hua kounga teitei. Kua hangaia āna whāriki kia tika, kia roa hoki te mau, kia tutuki ai ngā hiahia kanorau o ngā mahi tiaki niho.

Ngā Tiwhikete me ngā Whakatutukitanga

E tutuki ana a Denrotary Medical i ngā paerewa tiwhikete CE me te ISO 13485:2016. E piri ana tana awheawhe hou me tana raina whakaputa ki ngā ture hauora, kia mau ai te haumaru me te pono o ngā hua. E kitea ana te whakapau kaha o te kamupene ki te kounga i roto i ana tikanga whakamātautau pakari me te piri ki ngā paerewa o te ao.

Ngā Tohu Hokonga Ahurei

He tino pai te mahi a Denrotary Medical ki te whakakotahi i ngā hangarau matatau me te whakaputanga whai hua. Mā ōna pūkenga whakaputa hua teitei ka taea te tuku i ngā hua i te wā tika. Mā te arotahi a te kamupene ki te kounga me te auahatanga ka waiho hei whiringa pono mā ngā kaiwhakarato orthodontic o te EU. Mā tōna whakapau kaha ki te makona o ngā kiritaki ka kaha ake tōna tūranga i te mākete.

Kaiwhakarato 6: DENTAURUM GmbH & Co.KG

Tirohanga Whānui o te Kamupene

I whakatūria a DENTAURUM GmbH & Co.KG i te tau 1886, he kamupene Tiamana, he roa nei tōna hītori hiranga i roto i te mahi whakatikatika niho. Kei Ispringen, Tiamana tōna tari matua, ā, ko tētahi o ngā kamupene niho whānau tawhito rawa atu o te ao. E mōhiotia ana te kamupene mō āna hua kounga teitei me te whakapau kaha ki te auahatanga.

Ngā Hua me ngā Āhuatanga Matua

He whānuitanga o ngā hua whakatikatika niho a DENTAURUM, tae atu ki ngā whīra, ngā waea, me ngā mea pupuri. E tino whakanuia ana āna Discovery® Smart Brackets mō tōna tika me te ngāwari o te whakamahi. E whakarato ana hoki te kamupene i ngā waea titanium, e tuku ana i te ngāwari me te kaha pai. Hei tāpiri, mā tana pūnaha Retention Plus® ka angitu te maimoatanga mō te wā roa.

Ngā Tiwhikete me ngā Whakatutukitanga

E tutuki ana a DENTAURUM i ngā whakaritenga CE me ngā paerewa ISO 13485:2016. E tutuki ana i āna hua ngā whakaritenga pakari o te EU MDR, e whakarite ana i te haumaru me te pono. Kei roto i te pūnaha whakahaere kounga a te kamupene ngā arotake auau me ngā whakamātautau tino pai hei pupuri i te tutuki i ngā whakaritenga.

Ngā Tohu Hokonga Ahurei

Nā te roanga o te mōhiotanga o DENTAURUM me tana whakapau kaha ki te kounga, ka motuhake ai ia. Mā āna Discovery® Smart Brackets ka māmā ake ngā tikanga whakatikatika niho, ka pai ake te whai huatanga mō ngā kaimahi. Nā te arotahi a te kamupene ki te auahatanga me tana whānuitanga o ngā hua ka waiho hei whiringa pai i waenga i ngā kaiwhakarato whakatikatika niho o te EU. Nā tana whakapau kaha ki te pumau me ngā mahi matatika ka whakanui ake i tōna ingoa rongonui.

Kaiwhakarato 7: EKSEN

Tirohanga Whānui o te Kamupene

Ko EKSEN, he ingoa rongonui i roto i te umanga whakatikatika niho, kei Turkey te mahi, ā, e mahi ana ki ngā kiritaki puta noa i Ūropi. Kua hangaia e te kamupene he ingoa rongonui mō te tuku hua whakatikatika niho kounga teitei e tutuki ana i ngā paerewa o te ao. Me te arotahi ki te auahatanga me te tika, kua noho a EKSEN hei hoa pono mō ngā tohunga niho e rapu ana i ngā otinga pono.

Ngā Hua me ngā Āhuatanga Matua

He whānuitanga o ngā hua whakatikatika niho a EKSEN, tae atu ki ngā whāriki, ngā waea, me ngā taputapu. Ko āna whāriki here-ake kua hangaia hei whakaiti i te waku, hei whakarei ake i te whakamarie o te tūroro me te whai huatanga o te maimoatanga. Ka whakaratohia hoki e te kamupene ngā whāriki uku e whakakotahi ana i te pakari me te ataahua. Hei tāpiri, ka whakarite ngā waea āwhata a EKSEN i te kaha pumau, e whai wāhi ana ki ngā putanga maimoatanga whai hua.

Ngā Tiwhikete me ngā Whakatutukitanga

E piri ana a EKSEN ki ngā whakaritenga tiwhikete CE, me te whakarite kia tutuki i ana hua ngā paerewa haumaru me te kounga pakari o te Kotahitanga o Ūropi. E piri ana hoki te kamupene ki te ISO 13485:2016, e whakaatu ana i tana whakapau kaha ki te pupuri i tētahi pūnaha whakahaere kounga pakari. Mā ngā arotakenga auau me ngā whakamātautau pakari ka whakamanahia te pono o ana hua.

Ngā Tohu Hokonga Ahurei

E tū pakari ana a EKSEN mō tōna whakapau kaha ki te auahatanga me te makona o ngā kiritaki. Mā ōna whāriki here-ake ka māmā ake ngā mahi whakatikatika niho, ka whakaiti i te wā tūru mō ngā kaimahi. He kōwhiringa huna ngā whāriki uku mō ngā tūroro, ā, he mea rongonui rātou. Nā te arotahi a EKSEN ki te kounga me te tika, kua whiwhi ia i te ingoa kaha i waenga i ngā kaiwhakarato whakatikatika niho o te EU.

Kaiwhakarato 8: Dentsply Sirona Inc.

Tirohanga Whānui o te Kamupene

Ko Dentsply Sirona Inc., kei Charlotte, North Carolina te tari matua, he kaiārahi o te ao i roto i te hangarau me ngā otinga niho. Nā te mea he nui te aroaro o te kamupene ki Ūropi, kei mua tonu ia i te auahatanga i roto i te umanga whakatikatika niho. Nā te whakapau kaha o Dentsply Sirona ki te whakatairanga i te tiaki niho kua waiho hei ingoa pono i waenga i ngā tohunga o te ao.

Ngā Hua me ngā Āhuatanga Matua

He whānuitanga o ngā hua whakatikatika niho a Dentsply Sirona, tae atu ki ngā whāriki, ngā whakahāngai niho, me ngā otinga matihiko. Kua hangaia āna Whakahāngai Niho SureSmile® mō te tika me te whakamarie, mā te whakamahi i te hangarau whakaahua 3D matatau. Kei te whakarato hoki te kamupene i ngā Whāriki In-Ovation®, he hoahoa here-ā-unoa hei whakapai ake i te whai huatanga. Hei tāpiri, ka whakangawari ake ngā otinga reremahi matihiko a Dentsply Sirona i te whakamahere maimoatanga me te whakarei ake i te tika.

Ngā Tiwhikete me ngā Whakatutukitanga

E tutuki ana a Dentsply Sirona i ngā paerewa tiwhikete CE me te ISO 13485:2016, kia tutuki ai i āna hua ngā whakaritenga haumaru me te kounga teitei rawa atu. He nui ngā whakamātautau a te kamupene, ā, e pupuri ana i ngā tuhinga taipitopito kia rite ki ngā aratohu a te EU Medical Device Regulation (EU MDR).

Ngā Tohu Hokonga Ahurei

He tino pai a Dentsply Sirona ki te whakauru i te hangarau ki te tiaki niho. Ka tukuna e āna SureSmile® Aligners he huarahi maimoatanga kua whakaritea, hei whakarei ake i te pai o te manawanui. Ka whakangawarihia e ngā In-Ovation® Brackets ngā tikanga, ka whakaiti i te wā maimoatanga mō ngā kaimahi. Ko te arotahi a Dentsply Sirona ki te auahatanga me tana whatunga tautoko pakari e pai ai te whiriwhiri mā ngā tohunga niho.

Kaiwhakarato 9: Envista Holdings Corporation

Tirohanga Whānui o te Kamupene

Kei Brea, California te kamupene Envista Holdings Corporation, ā, he kaiwhakarato matua ia mō ngā hua me ngā otinga niho. Kei te ao whānui te kamupene, ā, he kaha tōna aroaro ki Ūropi. Kei roto i te putea a Envista ētahi o ngā waitohu rongonui o te umanga orthodontic, e whakaata ana i tana whakapau kaha ki te kounga me te auahatanga.

Ngā Hua me ngā Āhuatanga Matua

He whānuitanga o ngā hua whakatikatika niho a Envista mā roto i āna waitohu, pērā i a Ormco me Nobel Biocare. Ko te Damon™ System, he pūnaha whitiki here-whaiaro, tētahi o āna hua matua, e mōhiotia ana mō te whakaiti i te waku me te whakarei ake i te whakamarie o te tūroro. Ka whakaratohia hoki e Envista ngā otinga matihiko pērā i a Spark™ Aligners, e whakamahi ana i ngā hangarau matatau mō te whakamahere maimoatanga tika.

Ngā Tiwhikete me ngā Whakatutukitanga

E piri ana a Envista ki te tiwhikete CE me ngā paerewa ISO 13485:2016, me te whakarite kia tutuki i ana hua ngā whakaritenga haumaru me te kounga pakari o te mākete Pākehā. E whakatinana ana te kamupene i ngā tikanga whakahaere kounga tino pakari, ā, e whakahaere ana i ngā arotake auau hei pupuri i te tutuki i ngā ture MDR a te EU.

Ngā Tohu Hokonga Ahurei

Ko te kaha o Envista kei roto i tana kohinga hua kanorau me tana whakapau kaha ki te auahatanga. Ka hurihia e te Pūnaha Damon™ te maimoatanga orthodontic mā te whakapai ake i te whai huatanga me te whakamarie o te tūroro. Ka tukuna e Spark™ Aligners he otinga hangarau teitei mō te whakaora aligner mārama, e kukume ana i ngā tūroro e rapu ana i ngā kōwhiringa huna. Ko te whakapau kaha o Envista ki te kounga me tōna whānuitanga puta noa i te ao e waiho ana hei ingoa pono i waenga i ngā kaiwhakarato orthodontic EU.

Kaiwhakarato 10: 3B Orthodontics

Tirohanga Whānui o te Kamupene

Ko 3B Orthodontics, he ingoa pono i roto i te umanga whakatikatika niho, kua whakatūria hei kaiwhakarato pono o ngā whariki niho kounga teitei. Kei te United States te tari matua o te kamupene, ā, kua whakawhānui ake i tana whānuitanga ki te mahi ki ngā tohunga whakatikatika niho puta noa i Ūropi. Me te arotahi ki te tika me te auahatanga, kua hangaia e 3B Orthodontics he ingoa rongonui mō te tuku hua e tutuki ai ngā hiahia o ngā mahi whakatikatika niho hou. E whakanui ana te kamupene i te pai o te kiritaki, ā, e whai ana ki te whakarato i ngā otinga e whakarei ake ana i te tiaki tūroro.

Ngā Hua me ngā Āhuatanga Matua

He whānuitanga o ngā hua tiaki niho a 3B Orthodontics kua hangaia hei whakapai ake i ngā putanga maimoatanga. Kei roto i tana kohinga hua:

• Ngā Ārai WhakarewaE mōhiotia ana mō te pakari me te tika, ka whakarite ēnei whāriki i te tika o te whakarārangi niho.
• Ngā Ārai UkuHe kōwhiringa huna ēnei whāriki mō ngā tūroro e rapu ana i ngā otinga ataahua.
• Ngā Ārai Here-ā-WhaiaroHe mea hanga ēnei whāriki hei whakaiti i te waku, hei whakarei ake i te whakamarie o te tūroro, hei whakahaere hoki i te maimoatanga.
• Ngā Waea me ngā Taputapu Whakatikatika NihoKa tāpirihia ēnei hua ki ngā whāriki, kia rite ai te kaha o te kaha me te whai hua o te maimoatanga.

Ka whakauruhia hoki e te kamupene ngā tikanga hanga matatau hei hanga i ngā whāriki he maeneene ngā taha, hei whakaiti i te riri o ngā tūroro. Ka tutuki i āna hua te whānuitanga o ngā hiahia orthodontic, ā, he mea whiriwhiri maha mō ngā tohunga niho.

Ngā Tiwhikete me ngā Whakatutukitanga

E piri ana a 3B Orthodontics ki ngā paerewa ture tino pakari hei whakarite i te haumaru me te kounga o āna hua. Kei te pupuri te kamupeneTiwhikete CE, e whakaū ana i te tutuki i ngā whakaritenga haumaru me te hauora o te Kotahitanga o Ūropi. E tutuki ana hoki i ngā paerewa oISO 13485:2016, e arotahi ana ki ngā pūnaha whakahaere kounga mō ngā taputapu hauora. Mā ngā arotakenga auau me ngā whakamātautau pakari ka whakamanahia te pono o āna hua. Mā te pupuri i ēnei tiwhikete, ka whakaatu a 3B Orthodontics i tana whakapau kaha ki te tuku hua e tutuki ana i ngā paerewa o te ao.

TuhipokaMā te tiwhikete CE ka whakarite kia haumaru, kia whai hua, kia tika hoki ngā hua a 3B Orthodontics mō te whakamahi i ngā mākete o Ūropi.

Ngā Tohu Hokonga Ahurei

He mea motuhake a 3B Orthodontics mō tōna whakapau kaha ki te auahatanga me te kounga. Mā ōna whāriki here-ake ka māmā ake ngā mahi whakatikatika niho, ka whakaiti i te wā tūru mō ngā kaimahi. He otinga ataahua ngā whāriki uku, e kukume ana i ngā tūroro e pai ake ana ki ngā whiringa maimoatanga huna. Mā te arotahi a te kamupene ki te hanga tika ka puta he hua ōrite i roto i āna hua. Hei tāpiri, he tino pai te tautoko kiritaki a 3B Orthodontics, e āwhina ana i ngā tākuta whakatikatika niho ki te whakatau i ngā wero me te arotau i te tiaki tūroro.

Mā te whakakotahi i ngā hangarau matatau me te huarahi e aro ana ki te kiritaki, kua whiwhi a 3B Orthodontics i tōna tūranga hei kaiwhakarato pono i roto i te umanga whakatikatika niho. Nā tōna whakapau kaha ki te kounga me te auahatanga, he hoa nui ia mō ngā tohunga whakatikatika niho i Ūropi.

Me pēhea te whiriwhiri i ngā kaiwhakarato orthodontic tika mō ō hiahia i te EU

Te Aromatawai i ō Whakaritenga

Ko te mārama ki ngā hiahia motuhake o tētahi mahi whakatikatika niho te taahiraa tuatahi ki te whiriwhiri i te kaiwhakarato tika. Me arotake e ngā mahi ngā inenga matua kia tino rite ai te kaiwhakarato ki ā rātou whāinga whakahaere.He mea nui te wā tukui roto i te pupuri i tētahi mekameka tuku pumau me te karo i ngā whakararuraru. Me aroturuki hoki ngā mahi i te whai huatanga o te maimoatanga mā te whakatairite i ngā roanga maimoatanga kua whakatauhia ki ngā putanga tuturu. Mā tēnei ka āwhina ki te tautuhi mēnā kei te whai wāhi ngā hua a te kaiwhakarato ki te whakahaere i ngā rerenga mahi.

Mā te aroturuki i te haerenga mai o ngā tūroro me ngā hiahia whakatika ka nui ake ngā māramatanga. Ko te nui o te kore e tae mai, ko ngā whakatikatika auau rānei, tera pea he tohu i ngā raruraru ki te pono o te hua, ki te pai rānei o te manawanui. Mā te tātari i ēnei āhuatanga, ka taea e ngā mahi te whakatau mēnā e tutuki ana ngā tuku a te kaiwhakarato i ā rātou paerewa.

ēneika whakaratohia e ngā tohu he anga whānuihei aromatawai i te pai o te kaiwhakarato, me te whakarite kia whai whakaaro ngā tohunga whakatikatika niho ki ngā whakataunga.

Te Whakataurite i ngā Tuku Hua

He mea nui te whakataurite hōhonu i ngā āhuatanga o ngā hua me ngā au o ngā utu ina aromatawaihia ngā kaiwhakarato. Me tātari e ngā mahi ngā rautaki utu a ngā kaiwhakataetae kia kitea ai ngā āputa me ngā whai wāhitanga. Hei tauira,Mā te mārama ki te ngāwari o te utu ka āwhina i te whakataute pānga o ngā panonitanga utu ki te tono. Mā tēnei māramatanga ka taea e ngā mahi te whiriwhiri i ngā kaiwhakarato e tuku ana i ngā utu whakataetae me te kore e whakararu i te kounga.

He maha ngā wā ka nui ake te ngāwari o ngā kaiwhakarato me ngā momo hua kanorau. Me arotahi ngā mahi ki ngā kāwai raraunga motuhake, pērā i ngā ia o te whakahekenga utu, ngā tuku whakakotahi rānei, kia nui ake ai te uara. Mā te whakamahi i ngā taputapu utu atamai ka taea te whakapai ake i te whakatau kaupapa mā te whakarato i ngā māramatanga mahi.

Hei tāpiritanga, he mea nui te aromatawai i te kounga o ngā rauemi e whakamahia ana i roto i ngā hua. Ka whai wāhi ngā whīra me ngā waea kounga teitei ki ngā putanga maimoatanga pai ake me te makona o te tūroro. Me whakatairanga ngā mahi i ngā kaiwhakarato e tuku tonu ana i ngā hua pono me te roa.Te tautuhi i ngā āputa i roto i ngā rautaki utu a ngā kaiwhakataetaeka taea hoki te āwhina i ngā mahi ki te arotau i ā rātou ake tauira utu, me te whakarei ake i tō rātou tūranga mākete.

Te Aromatawai i te Tautoko Kaihoko

He mea nui te tautoko kiritaki i roto i te whiriwhiri kaiwhakarato. Me aromatawai e ngā mahi te tere me te whai hua o te whakautu a ngā kaiwhakarato ki ngā patai, ki te whakatau rānei i ngā take.Ngā inenga pēnei i te wā urupare me te maha o ngā tautohewhakarato i ngā tohu ine mō te kounga o ngā ratonga.

Ko ngā kaiwhakarato he tere te aro atu me te iti o ngā reiti tautohe e whakaatu ana i te whakapau kaha ki te makona o ngā kaihoko. Me whai whakaaro hoki ngā mahi ki te wātea o ngā rauemi whakangungu me te tautoko i muri i te hoko. Mā ēnei ratonga ka taea e ngā tākuta niho te aro atu ki ngā wero, ka whakarei ake i te whai huatanga o te mahi whānui.

Mā te hononga roa ki ngā kaiwhakarato pono ka whakatairanga i te whakawhirinakime te māramatanga. Ko ngā kaiwhakarato e tutuki tonu ana i ngā wā mutunga me te tuku hua kounga ka whakapakari i ēnei whanaungatanga, ka hanga he turanga mō te tipu tonu. Mā te whakatairanga i te tautoko kiritaki, ka taea e ngā mahi te hanga mahi tahi kaha hei painga mō ngā taha e rua.

Te Whakaaro ki ngā Hononga Mō te Wā Roa

He painga nui te whakatū hononga roa ki ngā kaiwhakarato ratonga niho. Ehara i te mea ko ngā taunekeneke tauwhitinga anake ēnei hononga, engari ko te whakatipu i te whakawhirinaki, te pono, me te tipu tahi. Ko ngā tākuta niho e whakatairanga ana i ngā mahi tahi roa ka kite i ngā mahi maeneene ake, ā, ka pai ake ngā putanga o ngā tūroro.

Ngā Painga o ngā Hononga Wā Roa

1. Kounga Hua Pūmau

   Mā ngā kaiwhakarato pono ka whakarite kia rite te kounga puta noa i ā rātou hua. Ka taea e ngā tākuta niho whakahāngai te whakawhirinaki ka tutuki ngā paerewa teitei i ngā whāriki, ngā waea, me ētahi atu rauemi, ka whakaiti i te tūponotanga o ngā raruraru maimoatanga. Ka whakarei ake hoki te rite tonu i te makona o te tūroro, nā te mea ka pai ake ngā hua o ngā hua kounga teitei.

2. Te mekameka tuku kua whakangawaritia

   Mā ngā hononga roa ka māmā ake te whakahaere mekameka tuku. Ka mārama ngā kaiwhakarato kua roa nei e whai hononga ana ki ngā hiahia motuhake o ā rātou kiritaki. Mā tēnei mōhiotanga ka taea e rātou te matapae i ngā ota, te whakaiti i ngā whakaroa, me te pupuri i te rere pumau o ngā rauemi nui.

3. Te Whai Hua o te Utu

   He maha ngā kaiwhakarato e tuku ana i ngā hekenga utu, i ngā kaupapa pono rānei ki ngā kiritaki roa. Mā ēnei painga ka whakaitihia ngā utu katoa, ka taea ai e ngā mahi te tohatoha rauemi me te whai hua ake. Mā ngā whakaaetanga hoko nui, ngā whakaritenga motuhake rānei ka nui ake te penapena utu.

4. Te Uru ki te Auahatanga

   He maha ngā kaiwhakarato pono e whakarato ana i te urunga wawe ki ngā hangarau me ngā hua hou. Ka taea e ngā tākuta niho whakahāngai te noho ki mua i ngā au o te ahumahi mā te whakamahi i ngā otinga auaha. Mā tēnei urunga ka noho whakataetae tonu ngā mahi, ā, ka tukuna hoki te tiaki matatau ki ā rātou tūroro.

Ngā Take Matua mō te Hanga Hononga Kaha

Ngā Tohutohu mō te Kōwhiri i te Hoa Tika

TohutohuArotakehia te hītori mahi a te kaiwhakarato i mua i te whakaae ki tētahi hononga roa. Rapua ngā arotake pai, ngā whakaaturanga, me ngā rangahau take e whakaatu ana i tō rātou pono me te ratonga kiritaki.

Me arotake anō hoki e ngā tākuta niho ā-whatu te kaha o te kaiwhakarato ki te whakanui ake i ngā mahi. Ko ngā mahi e tipu haere ana me whai hoa mahi ka taea te whakatutuki i ngā tono e piki haere ana me te kore e whakararu i te kounga. Hei tāpiri, ko ngā kaiwhakarato e tuku ana i ngā rauemi whakangungu me te tautoko hangarau ka tāpiri uara ki te mahi tahi.

Ka whai hua ngā taha e rua i ngā mahi tahi mō te wā roa. Ka whiwhi ngā kaiwhakarato i ngā kiritaki pono, ko ngā tākuta niho ia ka whiwhi i te ratonga pumau me te urunga atu ki ngā hua auaha. Mā te whakatairanga i te whakawhirinaki me ngā whāinga tahi, ka taea e ngā mahi niho te hanga hononga hei akiaki i te angitu mō ngā tau e haere ake nei.

Ko ngā kaiwhakarato whīra niho tekau kua whakamanahia e te CE i Ūropi he tino pai ki te kounga, ki te auahatanga, me te makona o te kiritaki. Ko ngā kamupene pēnei i a Align Technology me Ormco te kaiārahi me ngā otinga matatau, ko Denrotary Medical me DENTAURUM GmbH te hunga e whakaatu ana i ngā pūkenga hanga tino pai. Ko ia kaiwhakarato e whakatairanga ana i te tutuki i ngā paerewa tiwhikete CE me te ISO 13485:2016, kia mau ai te haumaru me te pono.

TohutohuArotakehia ngā hiahia o tō mahi, te whānuitanga o ngā hua, me te tautoko a ngā kaiwhakarato i mua i te whakatau. Mā ngā hononga roa me ngā kaiwhakarato pono ka taea te whakarei ake i te whai huatanga me te tiaki tūroro.

He mea nui tonu te tiwhikete CE hei pupuri i ngā paerewa teitei mō te mahi niho, hei tiaki i ngā tohunga ngaio me ngā tūroro.

Ngā Pātai Auau

He aha te tiwhikete CE, ā, he aha i hiranga ai mō ngā hua tiaki niho?

Mā te tiwhikete CE ka tutuki i tētahi hua ngā paerewa haumaru, hauora, me te taiao o te Kotahitanga o Ūropi. Mō ngā hua whakatikatika niho, ka oatihia te tutuki i ngā ture tino pakari, ka whakarite i te haumaru o te tūroro me te pono o te hua.

Me pēhea e taea ai e ngā tākuta niho te whakamana mēnā kua whai tiwhikete CE tētahi kaiwhakarato?

Ka taea e ngā tākuta niho whakahāwea te tirotiro i ngā tuhinga mana a te kaiwhakarato, i te tapanga hua rānei, mō te tohu CE. Hei tāpiri, ka taea e rātou te tono tiwhikete hanganga ture, te manatoko rānei i te rēhitatanga o te kaiwhakarato ki ngā whakahaere ture o te EU.

He aha ngā painga o te whiriwhiri i ngā whīra niho kua whakamanahia e te CE?

Mā ngā whīra niho kua whakamanahia e te CE ka whakarite kia kounga teitei ngā rauemi, kia haumaru, kia tutuki hoki ngā paerewa o te EU. Ka whakaitihia e rātou ngā mōrearea e pā ana ki ngā hapa o te hua, ā, ka whakarei ake i te whakawhirinaki o ngā tūroro ki ngā maimoatanga orthodontic.

He aha te hononga o te ISO 13485:2016 ki ngā kaiwhakarato ratonga niho?

Mā te ISO 13485:2016 ka whakatūria ngā paerewa whakahaere kounga mō ngā taputapu hauora. Ko ngā kaiwhakarato tiaki niho e piri ana ki tēnei paerewa e whakaatu ana i tā rātou whakapau kaha ki te whakaputa hua haumaru, pono, me te kounga teitei.

He aha te tūranga o te auahatanga i roto i te whakawhanaketanga o ngā hua orthodontic?

Mā te auahatanga ka ahu whakamua ngā mahi tiaki niho, pērā i te tānga 3D me te whakamahere maimoatanga e whakamahia ana e te AI. Ka whakapai ake ēnei hangarau i te tika o te hua, ka whakaiti i ngā wā maimoatanga, ā, ka whakarei ake i te whakamarie o te tūroro.

Me pēhea e taea ai e ngā tākuta niho te aromatawai i te ingoa pai o tētahi kaiwhakarato?

Ka taea e ngā tākuta niho whakahāwea te arotake i ngā whakaaturanga a ngā kiritaki, ngā whakatauranga, me ngā rangahau take. Mā ngā arotake kua manatokohia mai i ētahi atu tohunga ka kitea te pono o te kaiwhakarato, te kounga o te hua, me te ratonga kiritaki.

He aha te hiranga o te tautoko muri-hoko mō ngā kaiwhakarato ratonga niho?

Mā te tautoko i muri i te hoko ka āwhinahia ngā tākuta niho ki ngā take hua, te whakangungu, me te tiaki. Mā te tautoko pono ka whakatipu i te whakawhirinaki, ā, ka āwhina i te whakahaere pai o ngā mahi niho.

He aha ngā āhuatanga me whai whakaaro ngā tākuta niho ina whiriwhiri ana i tētahi kaiwhakarato?

Me arotake e ngā tākuta niho whakahāwea te kounga o te hua, ngā tiwhikete, te tautoko kiritaki, me te auahatanga. Mā te mahi tahi roa me ngā kaiwhakarato pono ka whakarite kia rite tonu te ratonga me te urunga atu ki ngā otinga matatau.

TohutohuMe whakarite i ngā kaiwhakarato kua whakamātauhia te tutuki i ngā whakaritenga me te makona o ngā kaihoko.