Ritamedtech (Zhongshan) Limited
Ritamedtech (Zhongshan) Limited (inozivikanwa seRitamedtech) yakatangwa muna 2023. Ikambani iri pasi peHongrita Group inonyanya kushandira indasitiri yezvekurapa, ichipa mhinduro dzakakwana dzekugadzira mapurasitiki emhando yekutanga kusvika yechitatu ekushandisa pakurapa uye zvikamu zvemhando yepamusoro zvesilicone rabha (LSR) nemamodule kune vatengi vane mukurumbira pasi rose.
Ritamedtech inoshandisa Class 100,000 (ISO 8) GMP Cleanroom ine chitupa uye Class 10,000 (ISO 7) GMP Laboratory, ine HEPA-filtered clean air-conditioning system, system yekuchenesa mvura, Environmental Monitoring System, uye sterilization facilities munzvimbo dzekugadzira. Kambani iyi inochengetedza kugona kwayo kwekuongorora kusabereka, kuongorora bioburden, uye kuongorora tunhu, zvichitsigirwa neISO13485 Quality Management System ine chitupa. Iyi framework yakabatana inoita kuti pave nekutevedzera zvizere mitemo yeChina's Medical Device Good Manufacturing Practice (MDGMP 2014), Management Requirement for Aseptic Medical Device Manufacturing (YY 0033-2000), Code for Design of Cleanrooms (GB 50073-2013), Code for Construction and Acceptance of Cleanrooms (GB 50591-2010) uye US FDA 21 CFR Part 820—Quality System Regulation.
Ritamedtech yagara ichitevedzera chiono chekambani chekuti "Kugadzira Kukosha Kuri Nani Pamwe Chete", ichivimba nemapurasitiki aHongrita akanyatsogadzirwa uye rabha resilicone (LSR) Multi-Component uye maitiro akasiyana ekuumba, pamwe nemamold ane cavity yakakura nedzimwe tekinoroji huru. Pamwe chete neISO27001 Information Security Management System yepasi rose, ISO45001 Occupational Health and Safety Management System, ISO14001 Environmental Management System, uye hurongwa hweESG hwekambani, pasi pehutungamiriri hwechikwata cheinjiniya, tekinoroji uye manejimendi chine simba uye chakadzidziswa nehunyanzvi, inoshandisa zvizere kugona kweHongrita kwedhijitari uye kwakangwara kugadzira nekukurumidza kupindura zvinodiwa nevatengi uye kupa sevhisi yakazara, yakajeka, yakachengeteka uye yakavimbika inofukidza R&D yepfungwa yechigadzirwa, manejimendi yeNPI inoenderana nezvinodiwa, kugadzirwa kwemhando yepamusoro uye kutumira panguva chaiyo.