O oloa fa'atuatuaina ma mautu o le ola lea o se kamupani.Talu mai lona fa'avaeina toeitiiti atoa le 5 tausaga talu ai, e fa'amuamua lava e le Epiprobe le tulaga lelei, e tu'uina atu ai i tagata fa'aoga ni oloa e su'esu'e vave ai le kanesa maualuga ma fa'atuatuaina.I le aso 9 o Me, 2022, i le maeʻa ai o se iloiloga malosi a tagata atamamai mai le BSI British Standards Institution Certification (Beijing) Co., Ltd., na faʻamanuiaina e Epiprobe le faʻamaonia o le "ISO 13485:2016" faʻataʻitaʻiga o masini faʻafomaʻi.O le lautele o le faʻaoga o loʻo aʻafia ai o le mamanu, atinaʻe, gaosiga, ma le tufatufa atu o pusa suʻesuʻega o suʻega methylation (PCR-fluorescence method).
Le taua o le faʻatinoina o le ISO 13485 certification
O se faʻamaoniga atoatoa lea o le faagasologa atoa o suʻesuʻega ma atinaʻe oloa, gaosiga, ma faʻatau atu i totonu o le kamupani, e faʻaalia ai o le faiga o pulega lelei a le kamupani o loʻo tausisia tulaga faʻavaomalo o ISO 13485: 2016 mo masini faʻafomaʻi faiga faʻaleleia lelei.E mafai e le kamupani ona faʻaauau pea ona gaosia ma tuʻuina atu oloa maualuga e fetaui ma manaʻoga o tagata faʻatau masini faʻafomaʻi, ma ua ausia tulaga faʻavaomalo i le mamanu o oloa, atinaʻe, gaosiga, ma faʻatau.O lo'o fa'ailogaina ai le fa'aleleia atili o le tulaga lelei o le pulega a le Epiprobe e aofia ai le fa'asologa atoa o le ola o oloa ma le aga'i atu i tulaga fa'ata'atia, fa'avasegaina, ma fa'ava-o-malo o lana pulega lelei.
E uiga ile ISO 13485 Certification System
ISO 13485: 2016 o se faʻataʻitaʻiga pulega lelei na atiaʻe e le International Organization for Standardization (ISO) faʻapitoa mo le falemaʻi masini masini (e aofia ai in vitro diagnostic reagents), e aofia ai faiga e pei o le mamanu ma le atinaʻeina, gaosiga, ma le tufatufaina o masini faʻafomaʻi.O lenei faʻataʻitaʻiga o le faʻaoga masani faʻavaomalo tulaga faʻapitoa i totonu ole falemaʻi masini faʻafomaʻi ma faʻatusalia faiga sili ona lelei ile pulega lelei mo le faʻalapotopotoga faʻavaomalo faʻafomaʻi.
Le Fa'asologa o Fa'ailoga o le Epiprobe's ISO 13485 Certification
I le masina o Aukuso 2021, na talia aloaia ai e le ofisa fa'amaonia le talosaga a le Epiprobe mo le fa'amaoniaina o faiga tau pulega lelei.Mai le aso 1 o Mati i le aso 3, 2022, na faia ai e le au suʻetusi suʻega suʻesuʻega ma suʻesuʻega o tagata faigaluega, fale ma meafaigaluega, ma faʻamaumauga ma faʻamaumauga o le gaosiga a le kamupani, tulaga lelei, suʻesuʻega ma atinaʻe, pulega o pisinisi, ma matagaluega tau maketi.I le maeʻa ai o se suʻega faʻaeteete ma le faʻaeteete, na talitonu le au suʻesuʻe suʻesuʻe ua maeʻa le faʻatulagaina o le pulega lelei o le Shanghai Epiprobe Biology Co., Ltd. (Xuhui) ma le Shanghai Epiprobe Jinding Biology Co., Ltd. (Jinshan), o pepa talafeagai sa maeʻa. lava, ma le faʻatinoina o le tusi lesona lelei, faʻamaumauga o taualumaga, suʻesuʻega i totonu, iloiloga o pulega, ma isi faiga sa lelei ma atoatoa le tausisia o manaʻoga o le ISO 13485 standard.
O le pulega lelei atoatoa e fesoasoani ia Epiprobe e ausia ai taunuuga lelei
Talu mai lona faʻavaeina, Epiprobe ua tausisia le taua o le "tu i luga o oloa" ma faʻatuina se au suʻesuʻe suʻesuʻe i totonu e faʻatino le sauniuniga o pepa faʻatonuga lelei, suʻega i totonu ma isi galuega faʻatino e faʻamautinoa ai o oloa e matua tausisia tulaga faʻatonutonu ma pepa fa'alotoifale i le faagasologa atoa o le pulega o le olaga atoa, faasolosolo malie ona iloa lelei pulega lelei atoatoa.Ua maua e le kamupani le 4 Vasega I faʻamaumauga o masini faʻafomaʻi (Tala Lelei! Epiprobe Biology Obtains Two Class I Medical Device Filings for Nucleic Acid Extraction Reagents!) ma 3 European CE certifications for cancer gene methylation detection kits (Epiprobe's Three Cancer Gene Methylation Detection Kits Obtain European CE Certification), ma ua taulamua i le ulufale atu i le maketi o le kanesa gene methylation diagnostic.
I le lumanaʻi, Epiprobe o le a matua mulimulitaʻia manaʻoga o le ISO 13485: 2016 faiga faʻaleleia lelei, faʻapipiʻi i le faiga faʻavae lelei o le "Product-oriented, Technology-centered, and Service-oriented".O le au pulega lelei o le a faʻaauau pea ona faʻaleleia le lelei o sini faʻataʻitaʻiga, pulea lelei soʻotaga uma mai le atinaʻeina o le reagent i le gaosiga o gaioiga, ma faʻatinoina i taimi uma le faʻatonutonuina o le faʻagasologa ma tulaga lamatia manaʻomia o loʻo faʻamaonia i totonu o le tulaga lelei o pepa e faʻamautinoa ai le saogalemu ma le saʻo o oloa.O le a faʻaauau pea ona faʻaleleia e le kamupani lona tulaga lelei pulega, faʻamautinoa le lelei o oloa ma auaunaga, faʻaleleia le gafatia e faʻaauau pea ona faʻafetaui manaʻoga ma faʻamoemoega o tagata faʻatau, ma tuʻuina atu i tagata faʻatau oloa e suʻesuʻe vave oloa ma auaunaga.
Taimi meli: Apr-28-2023