Hitec Medical MDR kudzidziswa - UnyanzviDocumentationRmidziyo pasi peMDR(Chikamu 2)
Clinical evaluation zvinodiwa pasi peMDR
Clinical evaluation: Kuongororwa kwekiriniki ndiko kuunganidza, kuongorora, uye kuongororwa kwedata rekiriniki kuburikidza nenzira inoenderera uye inoshanda, uchishandisa data yakakwana yekiriniki kuti ione kutevedzera zvinodiwa neGSPR.
Clinical kuongorora: Ita ongororo yakarongeka yemasampuli evanhu kuti uongorore mashandiro uye kuchengetedzeka kwemidziyo yekurapa.
PMS: Kuongororwa kwemusika:Inoreva zviitiko zvese zvinoitwa nevagadziri uye vamwe vashandi vehupfumi mukubatana, nechinangwa chekumisikidza nekuchengetedza yazvino yakarongeka maitiro ekuunganidza nekupfupikisa zviitiko zvakawanikwa kubva kumidziyo yakatangwa uye iripo kana kushandiswa mumusika, uye uone kana matanho anodiwa ekugadzirisa uye ekudzivirira anoda kunzwisiswa.
PMCF: Kutevera musika wekiriniki yekutevera:Nzira uye maitiro ekushingairira kuunganidza uye kuongorora data rekiriniki nezvekuita kwechishandiso uye kuchengetedza.Sechikamu chezvinyorwa zvehunyanzvi, PMCF yakabatana uye inoshandiswa kugadzirisa chirongwa chePMS neCER.Inogona zvakare kushandiswa se template yePMCF mishumo.
MDR Chinyorwa 10:Vagadziri vachaita ongororo yekiriniki zvinoenderana nezvinodiwa zveChinyorwa 61 uye Appendix XIV, kusanganisira post market yekiriniki yekutevera PMCF.
MDR Chinyorwa 61: Simbiso yekutevedzera kuchengetedzwa kwekutanga uye kuita zvinodiwa kunofanirwa kuve kwakavakirwa padhata rekiriniki, pamwe nedata kubva pamusika wemusika wekutarisa PMS.Vagadziri vanofanira kuitisa kuongororwa kwekiriniki maererano nehurongwa uye fomu magwaro akanyorwa.
MDR Chinyorwa 54:Kune chaiwo Kirasi III uye IIb zvishandiso, mutumbi unoziviswa uchaita kiriniki yekuongorora yekubvunza maitiro:
Kirasi III inodyarwa michina
IIb inoshanda zvishandiso zvinobviswa kubva mumuviri wemunhu kana kupihwa kumuviri wemunhu nenzira ine njodzi.
Mamiriro anotevera haadi chirongwa chekuongorora kuongororwa kwekiriniki:
- Vandudza zvitupa zvinoenderana nemirau yeMDR;
- Kugadziriswa kwezvigadzirwa zvatova pamusika nemugadziri mumwe chete.Ichi chigadziriso hachikanganisa purofiti yengozi reshiyo yemudziyo;
- Kune akakodzera CS uye mutumbi wakaziviswa wakasimbisa kutevedzera chikamu chekiriniki kuongororwa muCS.
Nguva yekutumira: Jan-05-2024