FCEe motlotlo ho fuoa lengolo la ISO13485, e leng tekanyetso e tsebahalang lefatšeng ka bophara bakeng sa litsamaiso tsa tsamaiso ea boleng bo entsoeng ka lisebelisoa tsa bongaka. Setifikeiti sena se bonts'a boitlamo ba rona ba ho fihlela litlhokahalo tse thata bakeng sa lihlahisoa tsa bongaka, ho netefatsa ts'epo, ts'ebetso ea morao-rao, le bokhabane ts'ebetsong e 'ngoe le e 'ngoe. Mmoho le phaposi ya rona e hlwekileng ya maemo a hodimo ya Sehlopha sa 100,000, re na le meralo ya motheo le boitsebelo ba ho hlahisa dihlahiswa tse fihlelang maemo a phahameng ka ho fetisisa a polokeho le tshebetso, ho kenyeletswa ho tsamaelana le ditlhoko tsa FDA.
Ho sebelisana le Like Bio: Aesthetic Device Innovation
Joalo ka Bio, k'hamphani e sebetsanang le lisebelisoa tsa bongaka tse ts'oaroang ka letsoho, e batlile mofani oa thepa ea nang le bokhoni bo matla ba boenjiniere le nts'etsopele hammoho le meaho ea bohloeki e netefalitsoeng ke ISO13485. Qalong ea lipatlisiso tsa bona, ba ile ba supa FCE e le molekane ea loketseng. Joalo ka Bio qalong e fane ka mohlala oa 3D oa sesebelisoa sa bona, se neng se hloka ntlafatso ea ts'ebetso le bokhabane.
FCE e entse tlhahlobo e felletseng ea moralo le ho sisinya lintlafatso tse ngata ho ipapisitse le boiphihlelo ba rona bo boholo ba tlhahiso. Ho leka-lekanya ts'ebetso ea tekheniki le litlhoko tsa botle, re ile ra sebelisana haufi-ufi le moreki ka makhetlo a 'maloa, qetellong ra phethela tharollo e fetang tebello ea bona.
Mathata a ho Kopanya Mebala e Tloaelehileng bakeng saLikopo tsa Bongaka
Ka lebaka la botle ba sehlahisoa, Joalo ka Bio o kopile botala e le 'mala oa mantlha. Ho finyella sena ho ne ho hloka ho hlōla mathata a bohlokoa, ho kopanyelletsa le ho khetha thepa e loketseng, ho etsa bonnete ba ho kopanya mebala e nepahetseng, le ho boloka chai e ngata ea tlhahiso.
FCE e khothalelitse li-resin tsa polasetiki tsa boemo ba bongaka tse kopantsoeng le li-additives tse sireletsehileng tsa lijo ho fihlela sephetho se lakatsehang. Ka mor'a ho hlahisa lisampole tsa pele, 'mala o ile oa hlophisoa hantle ka ho bapisa lintho tseo moreki a li ratang le li-swatches tsa mebala tse tloaelehileng. Mokhoa ona o thata o ile oa fella ka hore ho be le mebala e tloaelehileng e khotsofatsang litebello tsa moreki.
Ho sebelisa DHR bakeng sa Traceability le Tiisetso ea Boleng
Ho latela ISO 13485 ho hloka litokomane tse hlokolosi le ho lateloa ha ts'ebetso eohle ea tlhahiso. Ho FCE, re khomarela tsamaiso e matla ea Histori ea Sesebediswa (DHR), e ngolang karolo e 'ngoe le e 'ngoe ea tlhahiso, ho kenyeletsoa linomoro tsa batch, li-parameter le lirekoto tsa taolo ea boleng. Sena se re nolofalletsa ho sala morao lirekoto tsa tlhahiso ho fihlela lilemo tse hlano, ho netefatsa boikarabello bo ke keng ba lekanngoa le tšehetso ea morao-rao ea tlhahiso.
Katleho ea Nako e Telele ka Tšebelisano
Boinehelo ba FCE ho boleng, ho latela melao-motheo ea ISO13485 ka tieo, le bokhoni ba ho rarolla liphephetso tse rarahaneng tsa tlhahiso li re tliselitse botumo bo botle. Tšebelisano ea rona le Like Bio e fetohile tšebelisano-'moho ea nako e telele, 'me lik'hamphani ka bobeli li rua molemo kholong e arolelanoang le mekhoa e mecha.
Ka ho kopanya theknoloji e tsoetseng pele, litsamaiso tse thata tsa boleng, le litharollo tse lokiselitsoeng, FCE e ntse e tsoela pele ho beha palo ea ho nepahala le ho ts'epahala indastering ea tlhahiso ea lisebelisoa tsa bongaka.
Nako ea poso: Nov-28-2024