Pa 28 th . Epulo 2022, Joytech adapereka chiphunzitso choyambirira cha EU MDR pa oyang'anira magazi athu osagwira, mutha kudziwa tsatanetsatane Pano.
Mu 2023, Joytech amalumikizana ndi ma thermometers, osalumikizana ndi ma thermometers ndi oyang'anira magazi atsopano onse ndi EU Mdr avomerezedwa.
Kodi CE (MDR) ndi chiyani?
Ponena za CETTETITETICUTITER, aliyense amadziwa. Pafupifupi malonda aliwonse ali ndi chiphaso chofanana ndi CE. MDR ndiye chidule cha ulamuliro wa chipangizo cha ku Europe, chomwe ndikusintha kwa CE (MDD) ndikuyika zofunika kwambiri pa chitetezo ndi magwiridwe antchito azachipatala. Timachitchanso CE (MDR).
Kodi pali kusiyana kotani pakati pa CE (MDD) ndi CE (MDR)?
MDR ndi malamulo ndipo Mdd ndi malangizo. Chifukwa ndi kukweza, kuchokera ku malangizo okhala m'malamulo, ma membala a EU adzawongolera chitsimikizo pa chitsimikizo ndi zotsatira zake.
Makamaka zimawonekera m'zinthu zotsatirazi:
1) Analimbitsa maudindo a wopanga.
a) Wopanga ayenera kukhala ndi mkulu wina wotsamira ndi ukadaulo mu gawo la zida zamankhwala (palibe chotsimikizika chomveka mu udani);
b) wopanga adzakhazikitsa ndikusintha mosalekeza zolembedwa ndikuwonetsetsa kuti ikupezeka pofunsidwa ndi dziko la National woyenera.
c) Opanga ayenera kuyankha pakuwunikira kosakanikirana ndi matebulo nthawi ina iliyonse kuti awonetsetse zolembedwa ndi kukonza dongosolo; (Zogulitsa za II)
d) Zochita zoopsa za makampani ogulitsa, zimakhala zovuta kuzilemba CE.
2) Kuchulukitsa kowonjezereka ndi kuwunika kwa Certifice.
a) Malamulo ophunzirira gulu: kuyambira 18 ku Mdidi 22 mu MDR;
b) Zinthu zoyambira zofuna za Seclist zimachuluka: kuchokera ku zinthu 13 mu mdd mpaka 23 zinthu mu MDR;
c) Kapangidwe ka CE Expecment yasintha ndikugawidwa: Zolemba zamaluso ndi zikalata zotsatsa (Mdd zimangofuna zolembedwa zamaluso);
d) lipoti lounikira. MDR imafuna makampani kuti mupereke mtundu wachinayi wa masikono achipatala, omwe ndi okhwimitsa zinthu zambiri kuposa mtundu wachitatu;
3) Kukula kwa ntchito
a) Mdd amangofuna zinthu zachipatala, pomwe MDR imaphatikizapo zida zina zosakhala zamankhwala
b) M'dd, zida zovomerezeka zimasungidwa ngati gulu la zida zachipatala ndipo musafune kulowererapo kwa thupi lodziwika bwino, pomwe MDR imafunikira thupi lodziwika kuti lipange mapangidwe opangira opaleshoni;
4) MDR imafuna kuwonekera kwambiri komanso kulakwika
a) adayambitsa chizindikiritso cha chipangizo cha Udi kuti muwonjezere cholakwika cha prophuka;
b) chidziwitso choyenera cha kampaniyo chidzasonkhanitsidwa ku Database ya Chipatala ku Europe (Edamed);
c) Khazikitsani polemba ma prs (ma PMS);
d) Thupi lodziwika lidzachititsa kuyesedwa kosakanikirana.
Kodi mayeso a MDR CE ndi chiyani?
Zochita zomwe tikulankhula zimagawika pafupifupi mitundu iwiri:
a) Mayesero azachipatala amagwiritsidwa ntchito pa anthu kuti apeze deta kuti atsimikizire chitetezo cha malonda.
b) Malipoti azachipatala amatsimikizira chitetezo komanso kugwirira ntchito kwa malonda kudzera pakuyerekeza kwa malonda (kuchokera pazinthu zitatu: Zochita zamankhwala, magawo aluso), kusanthula kwa deta, kuwunika kwa deta.
c) Ripoti lowunikira matendawa ndi gawo la Ce Usictict ndipo ilinso gawo lofunikira (lipoti la matenda ndi lipoti losafunikira ndi lipoti la CE Certification mukamagwiritsa ntchito chiphaso).
d) Pakadali pano, mtundu wachinayi wa Revication Reviction Actional adakwaniritsidwa, yomwe ndi lipoti lowunikira kwambiri lomwe limapangidwa molingana ndi vuto la matenda a Meddev 2.7.1.
Kudutsa Mdr Certification kumatanthauza kuti Joytech magazi Kupanikizika kwa magazi ndipo Thermomenti ya digito yafika pamapangidwe opanga mapangidwe, kupanga ndi kuwongolera kwapadera, ndipo imatha kupereka zida zotetezeka komanso zodalirika za ogwiritsa ntchito padziko lonse lapansi.
Nthawi yovuta kuthamanga kwa magazi ndi digito imapambana pomatamandana molakwika kuchokera kwa ogwiritsa ntchito pazotsatira zawo zolondola, kapangidwe kake ka ogwiritsa ntchito komanso luso labwino kwambiri. Tsopano adutsa chitsimikizo cha MDR, chomwe chingawonjezerenanso kukhulupirika kwa ogwiritsa ntchito ndi kukhutitsidwa ndi zinthu zathu.
Joytech Healthcare apitilizabe kudzipereka popereka Zida zapamwamba kwambiri komanso zimathandizira thanzi la ogwiritsa ntchito padziko lonse lapansi. Tikhulupirira kuti kudzera mu zoyesayesa zathu, zinthu zathu zabwino zimathandiza kuti mukhale ndi moyo wathanzi pamsika wapadziko lonse lapansi.
Ngati muli ndi mafunso kapena zosowa za magazi athu opanikizika ndi zinthu za thermometer, chonde khalani omasuka kulumikizana nafe.
