.ISO 13485hkamja lam hte seng ai jak ni hpe galaw ai ni a matu masat masa galaw ai lam hpe lawu na madang ni kaw nna chye na la mai ai:
1. Core Essence: Dai gaw hpa rai kun?
Langai, ISO 13485 gaw product standard n re ai sha, a .Kaja ai ladatSystem (QMS) madang. Shi a title gaw " .Tsi mawan ni{0}} Quality hpe hkang zing ai ladat ni - Tara masa ni a matu ra kadawn ai lam ni" ngu ai lachyum gaw, dai gaw .gara hku galaw shapraw ai ni gaw system langai hpe gawgap nna gram lajang aihkrang shapraw ai, rawt jat galu kaba wa ai, galaw shapraw ai, jung da ai, hte daw jau ai lam ni a lahkam shagu hpe hkang zing ai, kam mai ai, tara ni hpe hkan sa ai lam ni hpe galaw na matu.
2. Manu dan ai ni a matu ahkyak ai lam
1. Mungkan ting na gat lawk ni hpe "Passport" langai mi
Ndai gaw hkrak dik htum ai hte tatut galaw mai ai hpaga lam a lachyum rai nga ai. Mungkan ting na tara upadi hpung law law (EU a MDR/IVDR, US FDA, Miwa a NMPA, Japan a PMDA, ngu ai hpe masat da ai (sh) hkap la ai zawn re ai tara ni hpe hkan sa na matu npawt nhpang hku nna ISO 13485 hpe hkap la ma ai.
Uropa: ISO 13485 hpe hkan sa ai gaw MDR/IVDR tara ni a QMS ra kadawn ai lam ni hpe hkan sa na matu madung ladat rai nga ai.
Amerikan: FDA a QSR (21 CFR Daw 820) gaw ISO 13485 hte grai htuk manu ai.
Kaga gat lawk ni: Canada, Australia, Sinpraw Dingda Asia mungdan ni lawm ai mungdan law law gaw, galaw shapraw ai ni hta ISO 13485 masat masa galaw na matu hkrak (sh) grai tsun shadut ra ai.
Ndai masat masa n nga yang, galaw shapraw ai ni gaw, shanhte a arai ni hpe mungkan ting na gat lawk kaba ni hta dut shabra lu na n re.
2. Product Hkamja lam hte akyu rawng ai lam hpe jat ya ai, Risk hpe shayawm ya ai
ISO 13485 system a madung yaw shada lam gaw tsi mawan ni a shimlum lam hte bungli galaw ai lam hpe hkam la lu na matu re. Ndai madang hpe hkan sa ai hku nna, galaw shapraw ai ni gaw:
N-gun ja ai hkrang shapraw ai lam hpe hkang zing ai lam ni hpe gawgap na: User ni kaw nna hpang nna, jep joi ai lam hte hkam la ai lam hku nna, product design hpe hkrak hkra galaw na.
Hkum tsup ai hkrit tsang hpa hpe hparan ai lam hpe galaw sa wa na: Hkrit tsang hpa ni hpe tau hkrau hte hkang lu na matu, arung arai prat masa (design, galaw shapraw ai, galaw ai hpang, hpang) a daw shagu hta, hkrit tsang hpa hpe hparan ai lam hpe n-gun jaw na.
Ladat hpe hkang lu na matu sadi ra ai: Batch shagu a hkam kaja lam hpe n-gun jaw lu na matu, mari ai, galaw shapraw ai, jep joi ai, shinggyin tawn ai, htawt sit ai zawn re ai ladat yawng hpe tsap nna hkang lu na.
Tradeability system hpe gawgap na: N-gun n rawng ai arung arai langai kaw nna jahtum-user du hkra na arai langai a labau yawng hpe sawk sagawn lu ai, manghkang ni byin wa yang lawan ai hte hkrak ai hku bai myit dum lu na matu ahkang jaw ai.
Ndai lam gaw machyi masha ni hpe hkra machyi shangun ai lam, tsi tsi ai lam ni, tara shawk shawn ai lam ni hpe hkrak sha shayawm ya ai.
3. Operational awng dang lam hpe grau kaja hkra galaw ai, manu jahpu hpe shayawm ya ai
Ndai masa hpe gawgap na matu gaw, shawng nnan hta gumhpraw bang ra ai raitim, aten galu hta, manu jahpu hpe grai shayawm ya lu ai:
N kaja ai lam ni hpe shayawm nna bai galaw ai lam: Makawp maga ai lam hpe myit maju jung ai hku nna, lam ni hpe hkrak galaw ai gaw, n-gun n rawng ai, bai bungli galaw ai, hpang- ni hpe gram lajang ai hpang na manu hpe shayawm ya ai.
Ladat madang masat ai lam: Magam bungli ni hpe asan sha galaw nna lit ni hpe garan ginhka ai gaw, kata lam hte myit n hkrum ai lam hpe shayawm ya nna, bungli galaw ai lam hpe grau kaja hkra galaw ya ai.
Data{0}}driven dawdan ai lam: Ndai masa gaw, jahpan ni hpe madung tawn nna, sawk sagawn nna gram lajang ra ai, hparan hpareng ni hpe npawt nhpang lam ni hpe chye na lu hkra karum ya nna, hpaji rawng ai dawdan lam ni hpe galaw na matu karum ya ai.
4. Customers ni, bungli manang ni, hte gumhpraw bang ai ni a lapran kam hpa myit hpe jat ya ai
Customers ni (Htunghking ni, Tsi sarawun ni, machyi masha ni): ISO 13485 masat masa hpe mu ai gaw, company a arung arai ni hpe grau kam hpa mai ai hte shim lum ai ngu hkam la na matu woi awn nga ai, brand kam hpa ai lam hpe gawgap ya ai.
Hpaga galaw ai ni hte garan gachyan ai ni: Shanhte gaw, ISO 13485 masat masa hpe, garan jaw ai atsam a matu ra kadawn ai lam langai hku nna, law law lang ra ai.
gumhpraw bang ai lam: Certification gaw company gaw well- hpe kaja wa hparan ai, hkrit tsang hpa hpe hkang lu ai, n-gun ja ai n-gun atsam nga ai, n-gun n-gun n-gun n-gun n-gun n-gun n-gun n-gun n-gun n-gun n-gun n-nga ai hpe madun dan ai.
5. Regulatory yu reng ai lam hte rau hparan na matu Solid Foundation
Tsi mawan hpaga lam hpe grai hkang zing da ai. Nsen langai mi nga ai, masat da ai QMS ngu ai lachyum gaw, tara upadi ni hpe ahkang aya lu ai ni (FDA zawn, NMPA) n tsun shaga ai (sh) ayan jep joi ai lam ni hpe galaw ai shaloi, company gaw simsa ai hku bai htang lu ai, jep joi ai lam hpe hkap la na ahkaw ahkang hpe grai jat ya lu ai hte, n hkan sa ai majaw, galaw shapraw ai lam hpe pat kau ai, hka wa ai, shing nrai, gat lawk hpe pat hkum ai zawn re ai grai sawng ai akyu ni hpe koi lu ai.
6. Matut manoi rawt jat galu kaba wa ai htunghking hpe mawdaw gau ai
ISO 13485 hta company ni hpe hpaw ra ai.Teng man ai hte makawp maga ai lam (CAPA)galaw sa wa ai lam ni hte hparan hpareng ai lam hpe bai maram yu ai ladat ni. Ndai lam gaw company hpe shi a laurels ni hta n hkring n sa ai sha, manghkang ni hpe actively tam na matu, npawt nhpang lam ni hpe sawk sagawn na matu, bai byin wa na hpe pat shingdang na matu ladat ni hpe hkan sa na matu shadut ya ai, dai hku nna self{1}}amprovement a kaja ai shingra tara hpe shabyin ya nna, matut manoi rawt jat galu kaba wa ai.
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Madung lam langai gaw laksan ahkyak shatai ra ai:"Hkamja lam hte seng ai jak ni" yawng gaw "tsi mawan ni" n re.
Tsi Sara Kaba: Ana zinli hpe asan sha tsi lajang na matu, ana hpe jep chyoi na, makawp maga na, yu reng na, tsi lajang ai, shing nrai, shayawm kau na matu yaw shada ai. Shanhte a tara masa gaw grai ngang kang ai, shanhte gaw .law malawngISO 13485 hte seng ai tara ni hpe hkan sa ai.
Hkamja lam/ kaja ai arung arai ni: Hkamja lam hpe hkangzing ai lam, hkam kaja lam, sak hkrung lam hpe gram lajang ai lam ni a matu madung jai lang ai, hkam kaja ai masha jahpan ni a matu (ga shadawn, shinggyim masha ni a hpaji rawng ai band ni, hkum hkrang n-gun shadawn ai lam ni, massagers) ni a matu jai lang ai. Shanhte a tara gaw loi mi sha n-gun n rawng ai.
Raitim, dai masa gaw galai shai wa nga ai:
Boundary ni hpe Boundary: Hkamja lam hte seng nna, tsi hpaji lam hte grau ni htep wa ai magam bungli ni (ga shadawn, ECG, sai n-gun ni hpe yu reng ai), dai gaw tsi mawan ni hku nna bai garan ginhka ai lam de du wa chye ai ngu tsun ma ai.
Proactive hku nna hkap la ai lam: Ya aten hta tsi mawan hku n masat da ai rai yang pyi, hkamja lam hte seng ai jak galaw ai ni law law gaw ISO 13485 madang hpe atsawm sha hkap la ma ai, hpa majaw
Htawm hpang a matu hkyen lajang ai lam: Product hpe gram lajang ai (sh) feature jat wa ai kaw na pru wa ai byin mai ai tara masa ni hpe hkyen lajang ai.
Quality Galaw ai lam hpe madun dan ai: Gasat gala ai gat lawk hta, madang tsaw dik ai hpe jai lang nna, shanhte a hkam kaja lam hte shim lum lam hpe sakse madun na matu, laklai ai akyu hpe shabyin ya ai.
High High-End Customers ni a matu hkan sa ai lam ni: Tsi rung nkau mi (sh) hpaji jawng nkau mi gaw shanhte a manang ni hpe kaja ai hparan hpareng ai ladat hpe ra sharawng na re.
Gadun dawk
Hkamja lam hte seng ai jak ni hpe galaw ai ni a matu,ISO 13485 masat masa a lachyum hpe ndai hku shingdaw mai ai:
Sut masa lam, dai gaw .ja a sumrimungkan gat lawk ni de.
Hpaga lam a ningmu hku yu yang, dai gaw .gawpshim lum lam hte akyu rawng ai lam hpe hkam la lu na.
Management a ningmu hku yu yang, dai gaw .optimizern-gun grau ja wa na matu hte manu jahpu hpe shayawm na matu.
Ladat masa hku nna, dai gaw .jut lung sengkam hpa myit hpe gawgap na matu hte ngang grin ai rawt jat galu kaba lam hpe lu la na matu.
Dai majaw, tara shang masat da ai tsi mawan ni hpe galaw shapraw ai ni a matu (sh) hkamja lam hte seng ai hpaji masa hpe sung sung sawk sagawn na matu dawdan da ai company ni a matu rai tim, ISO 13485 masat masa hta gumhpraw bang nna lu la na matu, grai manu dan ai masing masa langai rai nga ai.
Na a hpaga lam a matu anhte a Ultrasonic san seng ai ni hpe hpa majaw lata la na kun?
·OEM/ODM Ready:Logo printing, nsam hpe gram lajang ai lam, packaging design ni hpe madi shadaw ai lam.
· Kabu gara ai manu:ultrasonic hpe jasan jaseng ai hte UV ana zinli hpe n-gun n rawng hkra galaw ai jak langai hta hpawng de ai.
·Stable Quality hpe hkang ai:Unit shagu hta ultrasonic frequency, UV n-gun, ngang grin ai lam ni hpe chyam yu ai.
· N-gun ja ai wa ra sharawng ai lam:Tinang hkum hpe san seng ai lam hte shim lum ai lam hpe myit maju jung ai lam law wa ai gaw, bai dut shabra ai lam hpe shabyin ya ai.
· Lawu kaw nna yu reng ai lam:Long-laga galaw ai arung arai ni hte hkam sha lu ai bungli ni gaw, warranty hpe shayawm kau ya ai.
Madung akyu ni
1. Dual jasan jaseng ai hpaji hpe grau kaja hkra galaw na matu
US100 Ultrasonic Cleaners nihpawng chyawm aiultrasonic vibration (>42,000Hz)dai hteUV{0}}C nhtoi hpe n-gun jaw ai, hkum tsup ai 2{{3}in{5}}1 hpe jaw ya ai. Dai ultrasonic wave ni gaw, n-gun ja ai n-gun ni hpe daw kau nna, yeng seng kau ya ai microbubbles ni hpe shapraw ya ai, UV-C nhtoi gaw, 99.99% bacteria hte virus ni hpe yeng seng kau ya lu ai, dai gaw, n-gun n rawng ai sha, grau sung ai, grau shim lum ai san seng ai lam hpe shabyin ya lu ai.
2. UV-
Dai hte hpring tsup aiUV{0}}C nhtoi htoi ai n-gang mali, ndai jak gaw san seng ai nta kata hta yawng shinggrup lu ai. Omnidirectional sterilization design gaw, n-gup n-gu (sh) mawn sumli ai arai ni a ntsa na lam shagu hpe maren mara n-gun n rawng hkra galaw ya ai, san seng ai lam hte jai lang ai ni a kam hpa myit hpe jat ya ai.
{0}}kH Madang- N-gun n-gun n-gun n-gun n-gun
Operating galaw ai42000H, US100 gaw, n-gun ja ai n-gun n rawng ai shara ni kaw na pyi, microscopic debris ni hpe shapraw kau lu ai, hkrak tup ai, tsaw ai{1}}energy wave ni hpe jaw ya ai. Ndai lam gaw, mawn sumli ai arai ni a n-gun ja ai lam ni, dental aligners ni a lapran na shara ni zawn re ai san seng ai lam ni a matu grai kaja ai.
4. Automatic 5-Minut jasan jaseng ai lam
DaiUV{0}}C function gaw minit 5 na ai hpang shi hkum shi hpaw mat ai, grai law hkra n-gun n-gun hte n-gun n-gun hpe pat shingdang ai. Ndai hpaji rawng ai aten masat masa gaw, n galai shai ai mahtai ni hpe lu la shangun ai, bungli galaw ai lam hpe shim lum hkra galaw ya lu ai, lang ai ni hte arai ni hpe jasan jaseng nga ai.
5. Multi- Yaw shada lam san seng ai atsam
Ndai unit gaw jai lang ai lam amyu myu a matu htuk manu ai majaw, gara product line hta raitim manu dan ai jat bang ai lam langai mi rai nga ai:
N-gup san seng ai lam:Dentures, n-gup n-gu, n-gup n-gu baw ni, n-gup n-gu ni hpe n-gup n-gu n-gun n-nga ai.
Ja lung seng rai:Rings, n-gup magap, shingkyit, na n-gup, hte lung seng ni.
Shani shagu na arung arai ni:Hka n shang ai aten ladaw ni, aten ladaw ni, gumhpraw dum ni, magri jak ni, arung arai kaji ni.
6. Lurable hte User-Matsaw ai hku hkrang shapraw ai lam
Hpre ai{0}} manu dan ai arung arai ni hte n-gun ja ai, n-gun rawng ai hkum hkrang hte gawgap da ai ndai jak gaw tsawm htap ai hte tatut galaw mai ai lam lahkawng yan rai nga ai. Shi a asan sha re ai langai mi-bubutton bungli hte automatic cycle gaw nta kaw, ha tsi rung ni hta, shing nrai, hkrun lam hkawm ai aten hta shani shagu lang na matu grai kaja ai.
Productions grau law hkra
HuizhouJa gumhprawHpaji masa Co,. Ltd hpe 2017 ning hta hpaw hpang wa ai rai nna, R&D, galaw shapraw ai hte dut shabra ai arung arai ni hpe na lu ai arung arai ni, CPAP hpe jasan jaseng ai hte kaga ni hpe hpaw hpang wa ai. Anhte gaw mahkrum madup nga ai hte myit rawt ai engineering hpung hpe electronic hte hkamja lam hte seng ai magam bungli ni hta shaning shi ning jan hpaji chye ai hpe gumrawng nga ga ai. Founders ni gaw TCL hte Alibaba zawn re ai mungkan sawk sagawn ai company ni kaw na pru wa ai ni rai ma ai. Shanhte gaw SONY, Harman, Philips, LG hte kaga company ni hta magam gun lai wa sai. Anhte a R&D hpung hta ID designer ni, software engineer ni, electronic engineer ni, jak hpaji ninghkring ni, quality engineer ni, mold engineer ni hte kaga ni lawm ai. Anhte a mahkrum madup nga ai ni gaw, nang ra sharawng ai lam ni hpe bawngban na matu hte, customer ni a myit dik lam hpe hpring tsup hkra galaw na matu, n-gun ja ai quality control hte myit sawn sumru ai customer service ni hpe galaw na matu ap nawng da ai. Dai hta n-ga, anhte gaw FDA, CE, FCC, RoHS, SGS hte PSE{9}} hpe hpaji ningnan ni hpe hpan shalat ai patent ni a matu copyright hte hpaji masa ni hpe lu la sai. Bai nna, Miwa, USA, Europe hte Japan mungdan ni hta hpaga masat kumla ni, brand hte patent ni hpe mung madu da ai. OEM hte ODM order ni hpe mung hkap tau la ga ai. Anhte gaw client yawng hpe awng dang lam hpe teng sha hpan shalat nna garan gachyan na ga ai. Nang hte rau bungli galaw na matu myit mada let, anhte hpe matut mahkai na matu hkap tau la ga ai.
Dai arung arai hpe lu la u
Hpang jahtum na arung arai manu ni hpe lu la na matu san sagawn ai lam hpe sa dat u.
1. Sample hpe sa ya ai aten: Sample ni hpe 1-3 ya laman hta sa ya na re.
2. Product hpe sa ya ai aten: Product ni hpe nhtoi 15-35 ya laman hta shagun na re. Shipping galaw ai shani hpe customization a yak hkak ai lam hte n-gun hpe madung tawn nna dawdan na re.
【Low MOQ n law ai. Mix color ni hpe hkap la ai. Amazon FBA labeling hte shawng nnan na sanghpaw li hpe daw jau ai.Support galaw ai ni hte lapran tsang kaji kaba ni hpe n-gun jaw ai, manu jahpu jaw ra ai, manu jahpu jaw ra ai, OEM, LOGO, packaging, stick bar code, box mark, pre{3}} garan ai lam yawng hpe gram lajang mai ai.
Anhte gaw, EXW,FOB,CIF,DDU(Casi n lawm ai sha chyinghka chyinghka chyinghka chyinghka kaw chyinghka chyinghka chyinghka chyinghka chyinghka kaw chyinghka chyinghka chyinghka chyinghka kaw chyinghka hpaw ai lam) hte DDP(custom clearance chyinghka chyinghka magam bungli) ni lawm ai hpaga lam hte seng ai ga si amyu myu hpe jaw mai ai.
OEM/ODM
OEM/ODM hpe gram lajang ai lam hta mungkan ting na customers ni a madung ra sharawng ai lam ni hpe anhte atsawm sha chye na ga ai. Shaning law law na hta-elpth supply chain hpaji hte digital bungli galaw ai mahkrum madup ni hpe jai lang nna, anhte a laksan laksan laksan galaw ai magam bungli ni gaw, ahkyak ai lam manga hta n bung ai akyu ni hpe gawgap ya ai, n bung ai shadawn shadang hte ra kadawn ai lam ni nga ai customers ni a matu galai shai mai ai hte hkrak ai hparan ladat ni hpe jaw ya ai:
LOGO- Htunghking hku nna galaw mai ai laksan brand LOGO.
PACKAGING{0}}Rgma ra ai design hparan ladat ni hpe jaw na.
EXTERIOR{0}} Htunghking nsam ni hte style .
Bungli galaw masha yawng a arung arai hte wenyi kabu gara lam hpe hkan shachyut ai shaloi, anhte gaw loi ai{0}}lang hta na loi ai{1}}lang hte nta kata na hkamja lam hte seng ai arung arai ni hpe jaw ya ai, dinghku shagu gaw tinang a hkamja lam hpe loi loi hte makawp maga ya lu nna, shinggyim hkamja lam hte kabu gara lam hpe madi shadaw ya lu ai.
1.20'YYEARS A supplier mahkrum madup
2.Lani mi{1}} n-gun jaw ai magam bungli
3.100% jep joi ai lam n galaw shi yang
4.Dust- lawt lu ai Purifcaton Pant
anhte a jakrung
Dai jakrungMiwa mung, Huizhou mare hta nga ai rai nna, square meter 10,000 jan nga ai shara hpe shinggrup da ai. Dai gaw R&D hpung kaba langai hpe ID designer ni, software engineer ni, electronic engineer ni, jak hpaji ninghkring ni, jak hpaji ninghkring ni, kaja ai engineer ni, mold engineer ni, etc. ni lawm ai ngu gumrawng nga ai.
Anhte a manang
100+ brand kam hpa mai ai lata la ai lam
Anhte a masat masa ni
SGS.
FC
CHYE CHY NA
FDA
RoHS
client ni hpe jep joi ai lam
