Dhawaan, Haiyan Kangyuan MedicalQalabka Co., Ltd. ayaa si guul leh u gudbiyay ISO13485: 2016 shahaadada nidaamka maaraynta tayada qalabka caafimaadka.Dib u eegista oo dhan waxay qaadataa saddex maalmood,rku faraxsan nidaamka maaraynta tayada, aqoonsiga habraaca iyo falanqaynta, mas'uuliyadaha maaraynta, dib u eegista maamulka, ujeedooyinka tayada, falanqaynta xogta, khayraadka aadanaha, kaabayaasha, hababka la xiriira macaamiisha, design iyo horumarinta, soo iibsiga, wax soo saarka iyo adeegga bixinta iyo bakhaar, maamulka khatarta, habka xaqiijinta, xaqiijinta jeermiska, baafinta, heerka aqoonsiga, ilaalinta alaabta, la socodka iyo cabbiraadda qalabka xakamaynta, qanacsanaanta macaamilka Jawaab-celinta (oo ay ku jirto maaraynta cabashooyinka), nidaamka digniinta, hanti-dhawrka gudaha, xakamaynta badeecada oo aan waafaqsanayn, tillaabooyinka hagaajinta iyo ka hortagga, dib u eegista dukumentiga farsamada, iwm.

This hanti-dhawrka, oo ay xaqiijiyeen kooxda hanti-dhawrka goobta, ayaa xaqiijiyay in dhammaan hababka cilmi-baarista caafimaadka ee Kangyuan iyo horumarinta, wax-soo-saarka iyo iibinta lagu fuliyaa si waafaqsan qodobbada dukumentiyada nidaamka maaraynta tayada, waxaana lagu talinayaa in la bixiyo shahaadada.

Sida heerka nidaamka maaraynta tayada tayada caalamiga ah ee loo aqoonsan yahay warshadaha qalabka caafimaadka, halbeegga cusub ee ISO13485:2016 (nidaamka maaraynta tayada qalabka caafimaadka ee shuruudaha sharciyaynta) ayaa si rasmi ah loo sii daayay Maarso 1, 2016.Nooca 2016 ee heerka cusub ee ISO13485 wuxuu ku darayaa tiro badan oo ah hababka ugu wanaagsan ee warshadaha aaladaha caafimaadka, oo la jaan qaadaya shuruudaha qaar ka mid ah xeerarka aaladaha caafimaadka qaranka, waa nidaamka maaraynta tayada iyo diiwaangelinta sharciyeynta iyo kormeerida heerar aad isugu dhow.

Kangyuan Medical maray shahaado markii saddexaad, taas oo aan ka tarjumaysa aqoonsiga dhamaystiran ee alaabta Kangyuan by hay'adaha heerarka caalamiga ah, laakiin sidoo kale calaamadee jaangooyo dheeraad ah, halbeegyada iyo caalamiga ah ee nidaamka maamulka tayada caafimaadka Kangyuan.

Waqtigan xaadirka ah, Kangyuan Medical waxay sidoo kale fulinaysaa US FDA, codsiga shahaadada MDR EU iyo shaqo kale.Waxaan rajeyneynaa in iyadoo la kaashanayo "pass" caalami ah oo badan, Kangyuan waxay dabooli doontaa dhammaan noocyada kala duwan ee kateetarka silikoonka, tuubooyinka heerkulka, tuubbada marin-haweedka laryngeal, dhamaadkatuubada hawo mareenka, nuugistakateetarka, tuubada caloosha, waji-xidho kala duwan iyo alaabada kale ee la isticmaalo ee caafimaadka ee aduunka, u adeega bukaanno badan oo adduunka ah, iyo caawinta alaabta caafimaadka in si dhamaystiran loo cusboonaysiiyo!