Nkhani yabwino!Pa Okutobala 16, 2020, Shenzhen Pentasmart Technology CO,.Ltd idapambana chiphaso cha ISO13485 Medical Device Management System.

Dzina lonse la ISO13485: Muyezo wa 2016 ndi Medical device-Quality management system-requirements for regulatory, yomwe inapangidwa ndi SCA / TC221 Technical Committee yokhudzana ndi kayendetsedwe kabwino ndi zofunikira zonse zoyendetsera zipangizo zamankhwala, zomwe zimagwiritsidwa ntchito kwambiri padziko lonse lapansi.ISO 9001, EN 46001 kapena ISO 13485 nthawi zambiri amagwiritsidwa ntchito ngati zofunikira pamakina otsimikizira ku United States, Canada ndi Europe.Kukhazikitsidwa kwa njira yotsimikizira mtundu wa zida zachipatala kumatengera izi.Ngati zida zamankhwala zikufuna kulowa m'misika yamayiko osiyanasiyana ku North America, Europe kapena Asia, ziyenera kutsatira malamulo ofananirako.

Panthawiyi, Pentasmart idalandira satifiketiyo, yomwe idathandizira kwambiri kasamalidwe ka bizinesiyo ndikuwonetsetsa kuti zinthuzo zili bwino, motero zimachulukitsa kutchuka kwa bizinesiyo, kupititsa patsogolo kupikisana kwazinthu, kuthetsa zopinga zamalonda ndikupeza chiphaso cholowera. msika wapadziko lonse lapansi.