10 Fa'ata'ita'iga Fa'atau OEM Sili mo Falema'i (2026)

Falema'i ma IDN o lo'o su'esu'eina laina tuto'atasi po'o laina fa'ailoga papa'e e mana'omia se tusi ta'alo e mafai ona e ave i totonu o se potu su'etusi. O lenei ta'iala o lo'o fa'avasegaina tulaga pito i luga ole fa'atau oloa OEM mo le 2026 i la'asaga e mafai ona su'eina e feso'ota'i ile fa'aogaina o le FDA QMSR, EU MDR 2017/745, ma fa'amoemoega RoW filifilia.

O le ae mauaina se faiga fa'ailoga manino, fa'afanua tulaga, lisi siaki fa'amaonia, ma se fa'ata'ita'iga i autafa e mafai ona e kopiina i lau RFP. Le sini: fai fa'ato'a vave, puipui fa'ai'uga ile iloiloga a le QA/RA, ma 'alo'ese mai fa'ate'ia i lalo.

CTA vaivai: Mana'omia se pepa sauni-e-fa'aoga? Kopi le laulau fa'atusatusa o lo'o i lalo i lau pepa fa'asalalau, ona fa'aopoopo lea o le fua fa'atatau mai le vaega Methodology e fa'avasega ai tagata fa'atau.

Metotia: fa'afefea na matou togiina le au fa'atau

Sa matou fuaina fua e fitu e atagia ai le lamatiaga ma le taua mo faiga falemaʻi. Fa'aoga nei mea mamafa e fausia ai se sikoa mo lau lisi pu'upu'u.

• Fa'atonuga fa'atulafonoina ma sauni su'etusi - 22%

• Su'esu'e ma lelei matua — 16%

• Le loloto o le gaosiga ma le faʻalauteleina - 18%

• Fa'atuatuaina ma le saoasaoa (taimi ta'imua/MOQs/inventory) — 18%

• Fa'ainisinia galulue fa'atasi ma fa'apitoa - 10%

• Aofa'iga o tau ma aiaiga fa'apisinisi - 10%

• Fa'amaoniga & fa'amaoniga a tagata fa'atau - 6%

Fa'asologa o togi (ta'iala vave): 0–2 (le lava), 3–4 (fa'aalia), 5–6 (tutusa i le laina faavae), 7–8 (malosi), 9–10 (faataitaiga). Fuafua fa'ata'ita'iga ta'itasi, ona fa'atatau lea o le aofa'i o le mamafa mo le fa'atusatusaga i tagata fa'atau.

Mo fa'amatalaga loloto i agava'a ma ta'iala tau su'esu'ega, va'ai le falegaosimea gafatia ma meafaigaluega ma faleteuoloa & logistics faiga itulau.

Tulaga fa'atonutonu (US/EU/RoW) i se tepa

• Iunaite Setete (FDA QMSR): Ua mae'a le fa'aogaina e le FDA ma le ISO 13485:2016, fa'atasi ai ma le fa'amalosia e amata ia Fepuari 2, 2026. Fa'atali asiasiga ma fa'amaumauga e atagia ai fa'amatalaga QMSR ma fa'amoemoega fa'atatau i tulaga lamatia. Va'ai le vaaiga lautele a le FDA ile Quality Management System Regulation FAQs.

• Iuni a Europa (MDR 2017/745): O lo'o fa'amoemoeina e Fa'alapotopotoga Fa'asilasilaga le pulea malosi i luga o fa'atau oloa ma tagata fa'akonekarate gaosiga, e masani ona aofia ai le ISO 13485/MDSAP fa'amaonia, suiga-fa'asilasilaga, ma aia tatau. BSI aoteleina fa'amoemoega fa'amaumauga i totonu MDR fa'ata'ita'iga sili ona lelei.

Ia fa'atutusa au maliliega, faila, ma fa'amaoniga i nei fa'amoemoega e fa'aitiitia ai le tuai o tusipasi ma su'esu'ega.

Le 10 fa'ata'ita'iga fa'atau OEM (fa'atasi ai ma laasaga fa'amaonia)

1) ISO 13485 lautele, su'etusi tala'aga, ma QMSR alignment (faitotoa faavae)

O le a le mea: Fa'amaoniga e ogatasi le faiga lelei a le fa'atau oloa ile ISO 13485 ma fa'afanua ile QMSR a le FDA ile aso fa'atulafonoina ole 2026.

Le mafua'aga e taua ai mo falema'i/IDN: O le fa'amalieina o le QMS e fa'aitiitia ai le fa'aalia o fa'atonuga mo polokalame fa'ailoga tumaoti ma fa'aitiitia ai le avega su'etusi i lau feso'otaiga.

Auala e fa'amaonia ai: Talosagaina le tusipasi ISO 13485 (tuuina atu, numera, lautele, fa'amaonia), fa'amaumauga lata mai a le NB/MDSAP su'etusi, fua fa'atatau o le CAPA, ma se fa'afanua fa'amaufa'ailoga talatuu QS (DMR/DHF/DHR) i faila e fa'atatau i le QMSR.

Fu'a mūmū: Vaiti tusi fa'ailoga (fa'ata'ita'iga, tufa na'o), tusi pasi ua le maua, leai se fa'amaoniga o su'etusi lata mai, po'o le va'aia o le su'esu'eina o le CAPA.

Tulaga fa'afanua (US/EU/RoW): FDA QMSR (fa'aoga i le ISO 13485); EU MDR fa'atau oloa fa'amoemoega fa'atonutonu.

Fa'ata'ita'iga RFP/RFQ fesili: ' Tuuina atu lau ISO 13485 tusipasi ma le lautele e aofia ai mamanu/gaina o mea fa'apipi'i/meafaigāluega ma aotelega o su'ega mulimuli e lua ma le tulaga CAPA.'

Fa'amaoniga feso'ota'iga i talosaga: Tusi Faamaonia PDF; toe fa'asalaina lipoti su'etusi.

Fa'asinoga fa'aletulafono: FDA's QMSR va'aiga lautele ma fa'asologa o taimi.

2) MDR 2017/745 pulega fa'atau oloa ma fa'amoemoega a le Vaega Fa'asilasilaina (Polokalame a EU)

O le a le mea: Mana'oga va'ava'ai mo so'o-konekarate taua/tagata gaosi konekarate ina ia 'aua ne'i tuai lau auala CE.

Le mafua'aga e taua ai mo falema'i/IDN: Le pulea lelei o fa'atau oloa ose fa'aletonu masani a le NB e mafai ona taofia ai le fa'alauiloaina o igoa tumaoti.

Auala e fa'amaonia ai: O konekarate e fa'atagaina su'etusi e le'i fa'ailoaina ma fa'amatala fa'asilasilaga suiga; fa'atau oloa taua e umia ISO 13485/MDSAP; fa'amaumauga fa'atekinisi o lo'o fa'aalia ai asiasiga o lo'o o'o mai/fa'agasolo/fa'ai'uga ma va'aiga.

Fu'a mumu: Leai ni aia tatau su'etusi; pulea suiga le manino; fa'atau oloa e aunoa ma se fa'amaonia aloaia.

Fa'afanua tulaga (US/EU/RoW): EU MDR 2017/745 Annex IX/XI taiala e ala i pepa NB; ISO 13485.

Fa'ata'ita'i fesili RFP/RFQ: 'Lisi au fa'atau oloa fa'atauva'a fa'atasi ma tusipasi o iai nei ma fa'amaonia aiā tatau mo su'etusi/suia-fa'asilasilaga.'

Fa'amaoniga feso'ota'iga i talosaga: Lisi fa'atau oloa ma tusi pasi; Feso'ota'iga NB ile pulega fa'atau.

Fa'amatalaga: BSI's MDR fa'amaumauga fa'ata'ita'iga sili.

3) Le loloto o le su'esu'eina (meafaitino → fa'auma uma), sauni UDI, ma le fa'amaoni o le DHR

O le a le mea: Su'esu'eina fa'auma-i-u'u e lagolagoina e DHR malolosi ma fa'aigoaina UDI fa'ailoga ma tu'uina atu fa'amaumauga.

Aisea e taua ai mo falemaʻi / IDNs: E sili atu le suʻesuʻeina faʻavaveina suʻesuʻega, lagolagoina le toe faʻamanatuina o le sauni, ma tuʻufaʻatasia ma faiga faʻamaumauga a le falemaʻi.

Auala e fa'amaonia ai: Toe iloilo fa'ata'ita'iga DMR/DHF/DHR; fa'amaonia le su'esu'eina o meafaitino ile vevela/loti; faʻamaonia igoa UDI, faʻailoga saʻo vaega (pe a manaʻomia), ma faʻamaumauga faʻamaumauga (GUDID/Eudamed).

Fu'a mumu: vaelua DHR; o lo'o misi fa'amaumauga talia/fa'ailoga; fa'amatalaga UDI le fetaui; vaivai le pulea o igoa.

Tulaga fa'afanua (US/EU/RoW): FDA UDI ma GUDID; EU UDI/Eudamed; QMSR/ISO 13485 pulega faila.

Fa'ata'ita'i fesili RFP/RFQ: 'Ia saunia se DHR fa'asa'o e fa'aalia ai le fa'ailoga UDI, fa'amaumauga o le taliaina, ma COC meafaitino o lo'o nonoa i le fanua.'

So'oga fa'amaoniga i talosaga: fa'ata'ita'iga DHR; UDI screenshots (GUDID/Eudamed fa'amaumauga).

Fa'ata'ita'iga fa'amatalaga: Ose gaosimea pei O lo'o fa'amamafaina e le XC Medico le su'esu'eina o vaega fa'atasi ma le fa'ailoga leisa UDI; pe a su'esu'eina so'o se sapalai, fesili e va'ai pe fa'apefea ona fa'ailogaina fa'afanua i lotoa DHR ma fa'amaumauga fa'amaumauga.

Fa'asinoga fa'aletulafono: Fa'amatalaga fa'atonu a le FDA ma le EU UDI taiala (MDCG).

4) Faʻagasologa faʻamaonia le matua (IQ / OQ / PQ), SPC, ma le puleaina o suiga

O le a le mea: Fa'amaonia, mata'ituina faiga gaosiga (IQ/OQ/PQ) fa'atasi ai ma fa'atonuga fa'afuainumera ma pulea fa'ainisinia fa'ainisinia.

Aisea e taua ai mo falemaʻi / IDNs: Faʻaititia le latent quality escapes i implants ma lagolagoina le toe faʻaleleia faifaipea e aunoa ma se mea e ofo ai.

Auala e fa'amaonia ai: Talosagaina le fa'amaoniaina o le fuafuaga sili; IQ/OQ/PQ afifi mo faiga taua (fa'ata'ita'iga, fa'amaufa'ailoga pa puipui, ufiufi); fa'amautinoaga polokalame mo le gaosiga/QMS meafaigaluega; suiga-pulea ogalaau ma fa'amaoniga/fa'amaonia ma ala fa'ailoa.

Fu'a mumu: 'Su'ega-na'o' fa'alagolago pe a le mafai ona fa'amaonia fa'aleagaina/atoa; leai se fa'amautinoaga polokalame; ogalaau suiga faasolosolo.

Fa'asologa o fa'afanua (US/EU/RoW): Fa'ata'ita'iga fa'amaonia faiga a le FDA i lalo ole QMSR; ISO 13485 7.5; fa'amautinoaga polokalame fa'atatau i tulaga lamatia.

Fa'ata'ita'i fesili RFP/RFQ: 'Fa'asoa se vaega o le IQ/OQ/PQ sui mo se faiga fa'apitoa ma lau su'ega ECN ma le ta'amilosaga masani.'

Fa'amaoniga feso'ota'iga i talosaga: Toe fa'amaonia afifi; ECN fua fa'atatau.

Fa'asinomaga: FDA's sterilization and validation overview.

5) Le loloto o le gaosiga ma le gafatia e mafai ona fuaina (5-axis CNC, fa'auma, potu mama, fa'ata'ita'iga fa'amama)

O le a le mea: Le lautele ma le pulea o masini i totonu o le fale, faʻamaeʻaina, faʻaogaina o potu mama, ma le auala e faʻamaʻi ai (i totonu o le fale vs konekarate).

Le mafua'aga e taua ai mo falema'i/IDNs: O le loloto o le gafatia ile fale e fa'aitiitia ai le tu'uina atu, fa'amautu lelei, ma fa'apu'upu'u taimi ta'i mo OR-critical lines.

Auala e fa'amaonia ai: Ta'amilosaga fa'apitoa po'o le vitiō; lisi o meafaigaluega ma fa'apalepale; potu mama vasega; la'asaga i totonu ma fafo; sifi lona lua/si'i sauni; fa'ata'ita'iga fa'ama'i ma tiute fa'amaonia.

Fu'a mumu: La'asaga papa'u i totonu o le fale ma fa'alavelave lavelave; leai se fuafuaga si'itia; le manino o tiute fa'ama'i.

Tulaga fa'afanua (US/EU/RoW): ISO 13485; tulaga fa'amama fa'atatau (fa'ata'ita'iga, ISO 11135/11137/17665 e ala ile fa'ailoaina ole FDA).

Fa'ata'ita'i fesili RFP/RFQ: 'Tuu mai lau lisi o mea faigaluega (fa'atasi ai ma fa'amatalaga 5-axis), fa'amatalaga o potu mama, ma po'o fea faiga e fa'amaonia i luga o le 'upega tafa'ilagi vs outsourced.'

Fa'amaoniga feso'ota'iga i talosaga: Lisi masini; tusi faamaonia potu mama; fa'amatu'u fa'amaonia otootoga.

Fa'ata'ita'iga fa'ata'ita'iga: XC Medico fa'aalia le loloto i luga o le titanium, 316L, ma le foma'i-grade PEEK fa'atasi ai ma le fa'atonutonu lelei o masini ma su'esu'ega; toe iloilo mea a le fale gaosi oloa ta'amilosaga po'o se lisi o meafaigaluega e fa'amaonia ai le faigata fa'apena.

Soft CTA: E te manaʻo e faʻatusatusa vave gafatia? Fa'apipi'i au kamupani e tolu pito i luga i le laulau o lo'o i lalo ma fa'aopoopo le mamafa mai le vaega Methodology e va'ai ai po'o ai e ta'ita'ia.

6) Meafaitino ma faiga fa'apitoa (Ti‑6Al‑4V, 316L, PEEK; fa'apipi'i; togafitiga i luga ole laiga)

O le a le mea: Faʻamaonia le pulea o mea masani faʻasolosolo ma faʻamaonia faiga faʻapitoa i lalo ole biocompatibility ma faʻamaʻi faʻamaʻi.

Aisea e taua ai mo falemaʻi / IDNs: Faʻapipiʻi mea / faʻagasologa e afaina saʻo ai le saogalemu, faʻatinoga, ma le tau o le olaga.

Auala e fa'amaonia ai: Fa'asologa o meafaitino (COCs), fa'amaoniaga fa'apitoa, fa'amaoniga o le biocompatibility ISO 10993 mo masini fa'atusa, ma le fetaui ma faiga fa'amama filifilia.

Fu'a mumu: filifili COC vague; leai ni fa'amaumauga fa'amaonia mo fa'alavalava; le manino le mafuaaga ole biocompatibility.

Fa'afanua tulaga (US/EU/RoW): ISO 10993 aiga; ISO 19227 (mama o mea faʻapipiʻi faʻapipiʻi); tulaga fa'ama'i fa'ama'i ile faiga.

Fa'ata'ita'i fesili RFP/RFQ: 'Fa'asoa se seti COC fa'ata'ita'i ma se fa'amaumauga fa'amaonia mo so'o se fa'alavalava/togafitiga i luga ole laiga o lo'o fa'aaogaina i au fa'ato'aga.'

Fa'amaoniga feso'ota'iga i talosaga: Material COCs; fa'ailoga fa'amaonia fa'alavalava.

Faitau fa'amatalaga i mea e fa'aaogaina mo ipu: fa'amatalaga gaosiga o ipu titanium.

7) Fa'atuatuaina & saoasaoa (taimi ta'ita'i, MOQs, fuafuaga fa'amautu, OTIF)

O le a le mea: Fa'ato'a fa'atumu e lagolagoina e le manino taimi ta'ita'i, fetu'utu'una'i MOQs, ma i-taimi, atoatoa (OTIF) fa'atonuga tu'uina atu.

Aisea e taua ai mo falema'i/IDNs: Stable PO'O le fa'atulagaina e fa'alagolago i fa'amaumauga fa'alagolago; fa'atuatuaina fa'aitiitia le fa'avaveina o tau ma fa'aleaogaina.

Fa'afefea ona fa'amaonia: Talosaga mo taimi fa'asalalau fa'asoa/fa'aleaganu'u ta'ita'i, fa'asologa o le OTIF fa'asolopito, faiga fa'aputuga (saogalemu, uta), ma pa'aga fa'atau/fa'atau.

Fu'a mumu: Leai se fa'amatalaga OTIF po'o lipoti; 'fa'alagolago' tali i MOQ; taimi ta'ita'i e fealua'i lautele e aunoa ma se su'esu'ega a'a.

Fa'afanua Fa'atonu (US/EU/RoW): E le fa'avae fa'ata'atia, ae o KPI ma SOP fa'ata'ita'iga sili e fa'avaeina le fa'atuatuaina.

Fa'ata'ita'iga RFP/RFQ fesili: 'Tu'u atu le 12 masina mulimuli o le OTIF i le masina ma au ta'ita'i masani e fa'atatau i aiga oloa (stock vs custom).'

Fa'amaoniga feso'ota'iga i talosaga: OTIF dashboard; laulau-taimi; faiga fa'ameamea.

Alamanuia fa'ailoga fa'asinomaga i fa'auigaina ole OTIF: Fa'amatala a McKinsey ile OTIF.

8) Fa'ainisinia galulue fa'atasi (DFM/DFX, fa'ata'ita'iga saosaoa, ECN tali atu, fa'amaumau fa'amaumauga)

O le a le mea: Le mafai e le tagata fa'atau oloa e faipaaga i le mamanu-mo-gaosi, liliu vave fa'ata'ita'iga, ma fa'atautaia le fa'atonuina o pepa/suiga.

Aisea e taua ai mo falemaʻi / IDNs: O le galulue faʻatasi lelei e faʻaitiitia ai le tau o le olaga ma puipuia le faʻagesegese i taimi o iloiloga faʻatonutonu.

Auala e fa'amaonia ai: DFM/DFX deliverables; CAD/CAM filifili meafaigaluega; fa'ata'ita'iga/ECN liliu SLA; gagana/taimi-sone fa'asoa; faiga fa'atonutonu pepa.

Fu'a mūmū: Ta'amilosaga fa'ata'ita'iga umi, fesuisuia'i; fa'atagaga o suiga fa'apitoa; fa'atapula'a fa'ainisinia bandwidth.

Tulaga fa'afanua (US/EU/RoW): QMSR/ISO 13485 fa'asologa o fa'asologa ma fa'atonuga o pepa.

Fa'ata'ita'i fesili RFP/RFQ: 'Fa'asoa taimi masani mo ata ma fa'ata'ita'iga ma se fa'asologa o le ta'amilosaga ECN mo le tausaga ua tuana'i.'

Fa'amaoniga feso'ota'iga i talosaga: Fa'asologa fa'ata'ita'iga lata mai; ECN fa'amaumauga o tala.

9) Maufetuuna'i filifili filifili ma fuafuaga fa'aauau-puna lona lua

O le a le mea: Fa'atonuina le fa'atonuina o tulaga lamatia e fa'aitiitia ai fa'alavelave e ala i le lua-sourcing, fa'asoa saogalemu, ma fuafuaga si'itia.

Aisea e taua ai mo falemaʻi / IDNs: Faʻaauau e taofia faiga faʻaleaogaina ma puipuia tupe maua.

Fa'afefea ona fa'amaonia: Fa'asoa tulaga lamatia; faatulagaga lona lua; fa'aauauina pisinisi/fa'ata'ita'iga mo le toe fa'aleleia o fa'alavelave; filifiliga o uta ma faiga fa'avae.

Fu'a mumu: Fa'alagolago i nofoaga e tasi e aunoa ma se fa'alavelave; konekarate le malamalama; leai se su'ega DR.

Tulaga fa'afanua (US/EU/RoW): Fa'atauga fa'atatau ile tulaga lamatia ile QMSR/ISO 13485 fa'atasi ai ma ta'iala ISO 14971.

Fa'ata'ita'i fesili RFP/RFQ: ' Tu'u lau tusi resitala tulaga lamatia ma fa'amaumau fuafuaga fa'aauau mo aiga fa'ato'a pito i luga.'

Fa'amaoniga feso'ota'iga i talosaga: Fa'amatalaga resitara tulaga lamatia; Lipoti su'ega DR.

10) Aofa'i tau, tu'utu'uga fa'apisinisi, IP/mea faigaluega umia, ma SLA 'au'aunaga

O le a le mea: Le manino o faʻataʻitaʻiga tau, tuʻutuʻuga totogi, IP / mea faigaluega umia, ma tulaga o auaunaga e pulea le mafutaga.

Aisea e taua ai mo falemaʻi/IDNs: Faʻamatalaga manino e faʻaitiitia ai le tau atoa o le umiaina ma puipuia feeseeseaiga.

Auala e fa'amaonia ai: Pepa fa'aupuga fa'atasi ai ma le vaeluaga; tuutuuga totogi; fa'amaonia/fa'afo'i; manino le umiaina o meafaigaluega ma faila mamanu; fa'alilolilo/IP fuaiupu e fa'atatau ile igoa fa'alilolilo.

Fu'a mumu: Fuaiupu IP le mautonu; suia le umiaina o meafaigaluega; totogi o suiga fa'asalaga.

Fa'afanua Tulaga Fa'ata'atia (US/EU/RoW): E eseese tulafono o konekarate; ogatasi ma faiga faavae faaletulafono ma GPO.

Fa'ata'ita'iga RFP/RFQ fesili: 'Fa'apipi'i se ata MSA/solitulafono lelei e fa'aalia ai le umiaina o meafaigaluega, fa'aogaina o faila faila, ma suiga-fa'aaliga taimi.'

Fa'amaoniga feso'ota'iga i talosaga: Draft MSA; maliega lelei; faiga fa'amaonia.

Fa'ata'ita'iga laulau fa'atusatusa a le tagata fa'atau (kopi-sauni)

Kopi le laulau lenei i lau ripoti ma fa'aopoopo koluma fa'ailoga e fa'atatau i le mamafa o le Methodology.

Fa'atau	Tusipasi & lautele	Faiga fa'amaonia (IQ/OQ/PQ)	Taimi ta'ita'i (fa'asoa/fa'aleaganu'u)	MOQs	Su'esu'ega lautele	Meafaitino (Ti‑6Al‑4V/316L/PEEK)	Tiotio tiute	Fa'amatalaga

Lisi siaki fa'amaoniga (fa'apipi'i i lau RFP)

• Tulaga lelei & faʻatonutonu: ISO 13485 tusi pasi (faʻasalalau / numera / lautele / aoga); otootoga su'etusi mulimuli a le NB/MDSAP ma le tulaga CAPA; Fa'amaumauga o fa'afanua QMSR; UDI fa'ailoga ma fa'amatalaga fa'amaumauga (US GUDID/EU Eudamed).

• Fa'atinoga & fa'amaonia: DMR/DHF/DHR fa'ata'ita'iga; fa'amaonia fuafuaga sili; sui IQ/OQ/PQ afifi; fa'amatalaga fa'amautinoaga polokalame; fa'amaonia le fa'ama'iina (EO/radiation/steam) ma le fa'amaoniaina o afifi.

• Tilivaina ma fefa'ataua'iga: 12-masina fa'asologa o le OTIF; taimi masani e ta'ita'i ai aiga (stock vs custom); MOQs ma faiga fa'amaumauga; fa'ata'ita'iga MSA/maliega lelei, mea faigaluega/IP, ma fa'amaonia/fa'afo'i.

Mo talaaga faʻamaonia: FDA's sterilization hub (modalities and SAL) and BSI's MDR fa'amaumauga lautele.

FAQ: fa'atauga fesili e sili ona matou fa'alogo iai

Q: O a faʻamaumauga e tatau ona matou talosagaina mo le ISO 13485 ma le lautele? A: Talosaga mo le tusi faamaonia PDF faʻatasi ma le tuʻuina atu, numera, lautele (faʻataʻitaʻiga manino / gaosiga o mea faʻapipiʻi / meafaigaluega), ma aso faʻamaonia, faʻatasi ai ma faʻamatalaga lata mai a le NB / MDSAP suʻega ma le CAPA tapunia tulaga. Nonoa le pepa o lo'o seti i fa'amoemoega a le FDA QMSR e fa'amautinoa ai le saunia o le 2026; va'ai le FDA's QMSR FAQs.

Q: E fa'afefea ona tatou fa'aleleia mana'oga a le FDA QMSR ma EU MDR? A: Fai le ISO 13485/QMSR e fai ma fa'avae autu QMS, ona fa'apipi'i lea o fa'atonuga fa'apitoa a MDR-fa'atau oloa (va'aiga fa'atau oloa, su'etusi/suia aia tatau, fa'amaumauga fa'apitoa) pe a mana'omia e lau NB. O loʻo faʻamatalaina e le BSI faʻamoemoega i totonu lana MDR fa'ata'ita'iga sili ona lelei ta'iala.

Q: O le a le taimi talafeagai e ta'ita'ia ai mea fa'amanu'a/ivi? A: E eseese i le aiga ma le fa'afanua; tele polokalame o lo'o fa'amoemoe e lafo i totonu o aso i le 2 vaiaso mo SKU o lo'o i totonu ma le 4-12+ vaiaso mo ta'aloga masani, ae fa'amaonia i taimi uma laulau-vaega ma fa'amaumauga o uta. Fa'afetaui ma ou mana'oga fa'atulagaina po'o ma mata'itu fa'atinoga o le OTIF i masina ta'itasi e sa'o ai kosi.

Q: O ai e ana meafaigaluega ma faila faila i polokalame OEM? A: E leai se masani masani. Fa'amanino ile MSA/lelei maliega o lo'o umia meafaigaluega ma faila CAD, fa'afefea ona fa'amaonia suiga, ma mea e tupu ile fa'amutaina. Fa'atasi ma faiga fa'avae IP i totonu ma aiaiga GPO; talosaga vave se ata tusi lanu mumu e aloese ai mai mea e ofo ai.

Q: O afea e tatau ai ona tatou vaʻai i faʻamaoniga faʻagasologa e pei ole IQ/OQ/PQ? A: Mo soʻo se faʻagasologa faʻapitoa e le mafai ai e le asiasiga mulimuli ona faʻamaonia atoatoa le lelei. Talosaga mo se sui IQ/OQ/PQ afifi ma le fa'amaoniaina o fuafuaga sili; fusia i fa'ama'i fa'ama'i/fa'amauina fa'amaonia pe'ā fa'atatau i ai tagi fa'ama'i.

Laasaga e soso'o ai (fa'atasi ma se CTA vaivai e tasi)

• Kopi le laulau fa'atusatusa i lau ripoti ma fa'aopoopo le mamafa o sikoa mai le vaega Metotia.

• Fa'apipi'i le lisi siaki Fa'amaonia i lau RFP ma fa'atulaga se asiasiga i luga ole laiga po'o su'etusi fa'ata'ita'i e taula'i ile fa'amaoniaga, su'esu'eina, ma fa'amaoniga fa'amaoni.

• Lisi fa'ato'a fa'atau oloa e ausia tulaga pito i luga ole fa'atau oloa OEM, ona fa'atautaia lea o le PO pailate e fa'amaonia le OTIF ma le tafega o fa'amaumauga.

Soft CTA: Mana'o i se ulu e amata? Fa'aoga le laulau o lo'o i luga ma le RFP e fa'aoso i fa'ata'ita'iga ta'itasi e fau ai se lisi fa'asa'o i aso nei.

Fa'asinomaga (filifilia, pule)

• FDA Quality Management System Regulation FAQs - fa'asologa o taimi ma fa'ata'otoga va'aiga. https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions

• BSI MDR fa'amaumauga fa'ata'ita'iga sili ona lelei - fa'atonu fa'atonu tulaga. https://www.bsigroup.com/siteassets/pdf/en/insights-and-media/insights/brochures/bsi-md-mdr-best-practice-documentation-submissions-en-gb.pdf

• FDA UDI system overview ma GUDID. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system

• EU UDI taiala (MDCG). https://health.ec.europa.eu/system/files/2021-07/md_2021-19_en_0.pdf

• FDA sterilization hub - auala, SAL, tulaga aloaia. https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices

• McKinsey fa'amatala i le fa'amalamalamaina o le OTIF - metric clarity. https://www.mckinsey.com/capabilities/operations/our-insights/defining-on-time-in-full-in-the-consumer-sector

Fa'aaliga: O lenei ta'iala e fa'aaogaina gagana fa'atauva'a, fa'amaonia fa'amaonia. O tau e eseese i le lautele ma e masani ona sii mai; afai e aliali mai laina i au RFQ, tu'u atu e pei o le 'mai' aofa'i ma fa'amauina e mafai ona suia pe a mae'a iloiloga fa'apitoa.