Nekuwedzera kwekusimbisa kwepasi rose rekurapa mutemo, makambani ekumusoro anopinda muEuropean nemakero ekutenderera nguva dzekutungamira, asi kuongorora kwekuongorora) uye post-musika wekuongorora (PMS). Kune mutsauko wakakosha mukudzokorora zvine musoro, nzira dzekuongorora uye zvirango pakati pedu FDA uye EU MDR / IVDR.
Chii chinonzi FDA (US Chikafu uye Dhivha mishonga ?
yekutonga Zvemidziyo yakawanda, vagadziri vanofanirwa kuendesa 510 (k) kuratidza kuti chigadzirwa chavo chakachengeteka, chinoshanda, uye chakanyanya kuenzana nemudziyo wakatenderwa.
Chii chinonzi mdr (chekurapa mudziyo ?
wekurapa Izvo zvine zvinodiwa zvekuremerwa kwekiriniki, post-musika kuongororwa, uye zvinyorwa zvehunyanzvi kuti uve nechokwadi chekuchengetedza moyo murefu uye nekujeka.
Kufamba-famba zvese fda uye mdr kwakaoma kunzwisisa-asi kutsoropodza. PaJoytech, takavaka yakasimba yekuteerera system yekuteedzera kuti ibatsire vatariri vedu vebhizinesi kuzadzisa izvi zvinodiwa nechivimbo. Kunyangwe iwe uri kuwedzera kuUS kana kupinda iyo EU pasi peMDR, zvigadzirwa zvedu zvakasimbiswa, zvinyorwa zvehunyanzvi, uye hunyanzvi hwekudzora vari pano kuti vakutsigire.
W hat w e h ave?
PaJoytech, isu takatumira hwaro hwekumanikidza hwakasimba hwekupa simba revarooreso. Joytech akavaka yakazara yakazara uye inotaridzika-inotaridzika comliancer comporia inosangana nezvinodiwa neGlobal Reglatory zvinodiwa mumisika mikuru yezvekurapa.
FDA 510 (K) clearance
Joytech akasara akavapo kuvapo kwakasimba mumusika weUS, neyese yemitsetse yedu yemukati yatove fda yakajekeswa uye nekushingairwa kunopihwa vafambi vepasirese. Kuvaka pane ino Yakatenderwa Nheyo, isu tinoramba tichiisa mari muChigadzirwa ruzivo uye rekuzvidzora rekuvandudza kuti vasangane nekiriniki zvinodiwa uye zvakananga-zvakananga.
Muna 2025, takawedzera yedu FDA portfolio neye akati wandei zvitupa zvitsva:
Tubless kumusoro kumusoro ruoko rweropa presterns monitors - kupa yakawedzerwa portability uye mushandisi ruzivo.
Hombe-ruoko digital bp monitors (dbp-6186 / 6286b) - Yakagadzirirwa yakawedzerwa ruoko saizi (40-56 cm), ine bluetooth sarudzo.
Compressor Nebulizer (NB-1100 kusvika NB-1103) - FDA-yakajekeswa pasi peChigadzirwa Code Caf, inotsigira yakavimbika yekufema yekurapa kumba kana mumakirini.
EU MDR Certification
Joytech iri pakati pevekutanga veChinese Vagadziri kuti vazadzise EU MDR chitupa pasi pehunyanzvi hutsva. MunaApril 2022 , takagamuchira chitupa yedu yekutanga yeTüv Süd
Kubva ipapo, takaramba tichiwedzera yedu MDR-Certified portfolio gore pagore. Pakazosvika Gumiguru 2023 , zvese zvitsva-chizvarwa cheRourn linder monitors uye thermometers yakanga yagamuchira CE (MDR) kubvumidzwa. Kubva munaFebruary 2025 , yedu yechina batch yezvigadzirwa zvakasimbiswa zvinosanganisira:
Uku kuwedzera kuri kuramba kuchiratidza kuzvipira kwakadzama kwaBabytech kutevedzera, chigadzirwa chinogadzirwa, uye kutonga kwakanaka. Yedu yakazara Chigadzirwa Lifecle-Dhizaini, Kuedza, Kunogadzira, Kuongorora-Speed Kuongororwa kweEurope zvakanyanya, kupa simba
Zvimwe zviyero zvekudzora
Maitiro edu ekugadzira akanyorwa pasi ISO 13485 naMadsap , vanosangana nezvinodiwa zveUS, Canada, Australia, Japan, neBrazil.
Zvakare, zvigadzirwa zvechibayiro zvakare zvinoenderana neNMPA (China), Rohs, uye kusvika mirayiridzo, kusangana nezvokuchengeteka, uye zvinyorwa zvemamiriro ekunze muAsia neEU.
Izvo zvazvinoreva kune vedu varo？
Kushanda nemufaro zvinoreva zvinopfuura kungoisa chigadzirwa - zvinoreva kuwana mukana wekutora munhu anonzwisisa kuoma kwekutevedzera kwenyika dzese.
V Lower yekudzora njodzi uye mutengo - yedu yakagadzirira-kuenda-kuenda-kune-t-to-terms nePround Audits inoderedza mutoro pane yako yekunyoresa.
V kupinda inokurumidza
V Yakasarudzika Technical Notsigiro - Kubva Kune Technical zvinyorwa kune Clinical data, timu yedu yeimba yekutonga inopa rutsigiro rwakatemerwa kuti usangane neyako nzira.
V Reven In Mhando uye Kuongorora Kwemhando yepamusoro - Yedu Yemhando system yadarika yechitatu-yechitatu-yechiongorora, uye zvinyorwa zvedu zvinogara zvichichengetwa zvakagadzirirwa, kufungidzira pachena uye kushanda.
Mhedziso:
Semirayiro inochinja, ndizvo zvatichaita. nekuwedzera kuperekedzwa mberi anozvipira kuenderera kweropaJoytech
Isu tatobata zvitumbi nenzvimbo huru dzepasi rose, kusanganisira North America, EU, Asia, uye kupfuura.
Unoda kuziva kana isu takasimbiswa mumusika wako?
Kutsvaga yekudzora-gadzirira OEM / ODM Solution?
Batanidza nechikwata chedu nhasi kuti uongorore zvigadzirwa zvechitunyorwa, zvinyorwa zvehunyanzvi, uye mhinduro dzakagadziriswa dzeprojekiti yako. NaJoytech, kutevedzera kunova yako mukana wekukwikwidza.
