With the increasing tightening of global medical device regulation, overseas companies entering the European and American markets need to meet not only the complex pre-market approval requirements, but also deal with stringent Flying Inspection (No Notice Inspection) and Post-Market Surveillance (PMS). Sunt significant differentias in regulatory logica, inspectionem modos et poenas inter US FDA et EU MDR / IVDR.
Quid FDA (US cibo et medicamentis Administration) ? FDA moderatur in salutem et efficaciam medicinae cogitationes in Civitatibus Foederatis Americae. Nam maxime fabrica, manufacturers submittere debet DX (k) ad probare quod eorum productum est tutum, effective et substantialiter equivalent ad existentium probatus fabrica.
Quid est MDR (Medical fabrica ordinacione) ? Mdr est Europaeae Unionis scriptor ordinacione ad medicinae cogitationes, repositoque pristini MDD (Medical Directive). Hoc est strictter iudicium ad orci iudicium, post-foro custodialave, et technica documenta ut altius patientes estote salutem et diaphanum.
Navigating et FDA et mdr est universa, sed discrimine. In iktech, weve 'aedificavi robust global obsequio ratio ad auxilium nostrum negotium socii occursum his postulans signa cum fiducia. Utrum tu expanding ad US et intrantes EU in Mdr, nostri Certified Products, Technical Documentation, et Regulatory peritia sunt hic sustinere.
W hat W E Ave?
In iktech, nos statutum est fortis regulatory fundamenta ad nostram sociis globally. Ijtech has built comprehensive et deinceps-vultus obsequio compage quod occurrat global regulatory requisita per major medicinae fora.
FDA DX (K) Clearance
Iiique longa statutum est fortis praesentia in US foro, cum omnibus nostris core uber lineas iam FDA purgata et active supplevit global sociis. Building in hoc certified fundamentum, ut continuously investimus in productum innovation et regulatory renovatio ad occursum evolving orci necessitates et particeps-specifica project postulat.
In MMXXV, nos expanded nostri FDA Portfolio cum pluribus novis certificaciones:
Tubeless superius brachium sanguinem pressura monitors - offering enhanced portability et user experientia.
Magna-brachium Digital BP Monitors (Dbp-(VI) CLXXXVI / 6286b) - disposito extenso brachium magnitudinum (40-56 cm), cum Bluetooth options.
Compressor nebulizers (NB-MC ad NB-MCIII) - FDA-purgatus sub productum codice CAF, supporting certa respiratorie Lorem domi vel in clinics.
EU MDR Certification
JOKTECH est inter primos Seres manufacturers ad consequi EU MDR Certification sub Nova ordinacione. In April MMXXII , accepimus nostrum initial Mdr libellum ab TÜV Süd, operimentum products ut Digital Thermometers, infrared Thermometers, et non-Digital Sina in Sina Pumps Primo MDR Prima Sinis et pectore Pumps inter se.
Cum igitur nos continued expand nostri MDR-Certified Portfolio annuatim. Per Octobris MMXXIII , omnes generatio sanguinem pressura monitors et thermometris quod accepit ce (MDR) probat. Sicut Februarii MMXXV , nostri quarta batch de certified products includit:
Hoc permanentis expansion reflects iktech scriptor altum commitment ad obsequio, uber innovation, et regulatory excellentiam. Nostra plena uber lifecycle-consilio, testis, vestibulum, documenta, et post-foro custodialalce-occurrat Europe scriptor maxime rigorous signa, ferre nostris sociis per certified, ad-forum solutions per EU.
Alia regulatory signa
Nostrum vestibulum processus sunt certified sub ISO (XIII) CDLXXXV et mdsap , occurrens regulatory necessitatibus US, Canada, Australia, Japan et Brazil.
Item, iktech products etiam conformis ad NMPA (Sinis), Rohs et pervenire directamenta, testimonii salutem, environmental, et documenta signa per Asia et EU.
Quid est enim nostra sociis？
Working cum iktech modo plus quam sicut fontem productum-id est consortio consortem, qui intelligit complexities international obsequium.
V inferiore regulatory metus et costs - noster parati-ut-ire certificaciones et experientia cum global audits reducere onus in vestri locus adnotatione processus.
V citius Market obvius - cum pre-certified cogitationes, vos can launch in target regionum cum maior celeritas et paucioribus mora.
V customized technica et orci firmamentum - ex technica documenta ad orci notitia, nostra in-Domus regulatory quadrigis praebet tailored ad occursum tuum patria, specifica requisitis.
V Proben Quality et audit promptu - nostra qualis ratio transierunt plures tertius-pars audits et nostris documenta semper tenentur audit-paratus, cursus diaphis et efficientiam.
Conclusio, sicut ordinationes evolve, sic erit nobis. Ijtech committitur continuously expanding eius global obsequio Roadmap cum certificaciones ut FDA et MDR -ensuring nostri Partners sunt continua aditus ad certified, summus qualitas medicinae cogitationes in regulatur fora.
Nos iam tenere certificaciones per major global regiones, quos possidet America Septentrionalis, in EU, Asia et supra.
Vis scire, si nos certified in foro?
Vultus pro regulatory-promptus / ODM solutio?
Coniungere cum nostris quadrigis hodie explorarent Product Certification Details, Technical Documentation, et Tailored solutiones pro project. Cum iktech, obsequio fit competitive commodum.
