On 28 th . Kubvumbi 2022, Joytech yakawana kuburitswa kwekutanga kweEU mdr kune yedu isiri-Invasive yeropa monitors, iwe unogona kuwana iyo nhoroondo Pano.
Muna 2023, Joytech Bata thermometers, vasiri vanoonana thermometers uye monitorts matsva emadivi ese mdr ese eu mdr akatenderwa.
Chii chinonzi CE (MDR)?
Kana zvasvika kuna CE zvitupa, munhu wese anoziva nayo. Inenge indasitiri imwe neimwe ine inoenderana ce certification. MDR ndeyekupfupika kweEuropean Medical Medication mutemo, inova yekuvandudza kwaCe (MDD) uye inoisa zvakakwirira zvinodiwa pakuchengetedza uye kuita kwekushandisa kwekurapa. Isu tinodaidzawo icho CE (MDR).
Ndeapi misiyano pakati CE (MDD) uye CE (MDR)?
MDR ndeyeMutemo uye MDD iri rairo. Nekuti icho chinosimudzira, kubva kune zvakarairwa nemirairo, EU nhengo yeEU ichaverengera kudzora pamusoro pechirongwa uye mhinduro.
Inonyanya kuratidzwa mune zvinotevera zvinhu:
1) akasimbisa mabasa emugadziri.
a) Mugadziri anofanira kuve neanenge mumwechete wekutevedzera Officer ane hunyanzvi mumunda wezvemidziyo yekurapa (hapana chinodiwa chakajeka muMDD Directive);
b) Mugadziri anozogadzika uye achienderera mberi nekuvandudza zvinyorwa zvehunyanzvi uye ona kuti inowanikwa kana yakumbirwa nechiremera chenyika.
c) Vagadziri vanofanirwa kupindura kusaverengerwa kusarudzika nemitumbi inoziviswa chero nguva yekuvimbisa zvinyorwa zvehunyanzvi uye kuchengetedza hurongwa; (Kirasi II Zvigadzirwa)
d) yezvibodzwa zvine njodzi zvakanyanya zvekutengesa makambani, zvichave zvakaoma kunyorera CE.
2) kuwedzera kuwedzeredza gadziriro uye kuongorora kwakasimba kweCertification Ongororo.
a) Kuwedzera Classificification Mitemo: Kubva 18 muMDD kusvika 22 muMDR;
b) Zvinokosha zvinodiwa zvekutarisa zvinhu zvinowedzerwa: kubva gumi nematatu muMDD kune 23 zvinhu muMDR;
c) Iyo chimiro cheCE technical zvinyorwa zvachinja uye yakakamurwa mu: Zvigadzirwa zvinyorwa zvinyorwa uye post-kushambadzira zvinyorwa (mdn chete inoda zvinyorwa zvehunyanzvi);
d) Clinical ongorora mushumo. MDR inoda makambani kuti ape iyo yechina vhezheni yekiriniki edzidziso dzemishumo, iyo inonyanya kuomarara kupfuura yechitatu vhezheni;
3) Yakawedzerwa chiyero chekushandisa
a) MDD inongotarisana nezvigadzirwa zvine chekuita nekurapa
b) MuMDD, Reusable zvishandiso zvinogadziriswa sekirasi yemidziyo yekurapa uye haadi kupindira kwemuviri unoziviswa, nepo MDR ichida muviri unozivisa kuti uongorore midziyo yekuvhiya yekushandisa.
4) MDR inoda kuwedzera pachena uye kutengeserana
a) yakaunza iyo yakasarudzika mudziyo identifier udi kuti uwedzere chigadzirwa chekutengeswa;
b) Yakakodzera ruzivo rwekambani ichaunganidzwa muEuropean Medical mudziyo Database (Yakatongwa);
c) Gadzira iyo post-musika yekuongorora (PMS) system;
d) muviri unozivikanwa uchaita kuongororwa zvisina kujairika.
Chii chinonzi Clinical kuongororwa MDR CE?
Maitiro ekiriniki atiri kutaura anoda kugoverwa mumhando mbiri:
A) Miedzo yekiriniki inoshandiswa pane vanhu kuti vawane data kuratidza kuchengetedzwa kwechigadzirwa.
b) Misangano yekiriniki inonyanya kuratidza kuchengetedzwa nekubudirira kwechigadzirwa kuburikidza nekuenzanisa kwechigadzirwa (kubva pazvinhu zvitatu: kiriniki data, uye kuongorora kwezvinhu), kuongorora kwedata), kuongorora data.
c) Chirevo cheClinical ongorora chikamu che ce technical gwaro uye zvakare chikamu chakakosha
D) Parizvino, iyo yechina vhezheni yekiriniki yechiitiko ichiitwa, iyo iri mushumo wekuongorora kwekiriniki zvakaunganidzwa zvinoenderana nekiriniki yekuongorora meddeline meddev 2.7.1.
Passing MDR Certification zvinoreva kuti Joytech Ropa Purse Stritor uye Dhijitari thermometer yakasvika mumamiriro ezvinhu akasimba mukugadzirwa, kugadzirwa uye kukanganisa kwemhando, uye kunogona kupa zvakachengeteka uye zvakazara zvekurapa zvekurapa kune vashandisi pasi rese.
Joytech Ropa Purtst Monitor uye dijitital thermometer yakakunda rumbidzo yekupa kubva kune vashandisi kuyerwa kwavo kwakaringana, mushandisi-ane hushamwari dhizaini uye kuita kwakanaka. Zvino, ivo vakapfuura iyo MDR chitupa, iyo pasina mubvunzo kuenderera mberi nekuvandudza kwevashandisi 'kuvimba nekugutsikana mune zvatinogadzirwa.
Joytech Healthcare icharamba ichipiwa kupa Yakakwira-mhando zvekushandisa zvekurapa uye kupa hutano hwevashandisi pasi rese. Isu tinotenda kuti kuburikidza nekuedza kwedu, zvigadzirwa zvedu zvemhando zvinobatsira kune hupenyu hwako hune hutano mumusika wepasi rose.
Kana iwe uine chero mibvunzo kana zvaunoda nezve neropa redu rekumanikidza kutarisa uye thermometer zvigadzirwa, ndapota inzwa wakasununguka kutibata nesu.
