Maphunziro a Hitec Medical MDR - Tanthauzo la Migwirizano ya MDR

Chida chachipatala

Zimatanthawuza chida chilichonse, zida, zida, mapulogalamu, implant, zopangira, zinthu, kapena chinthu china chilichonse chomwe chimagwiritsidwa ntchito pokhapokha kapena kuphatikiza ndi wopanga pa cholinga chimodzi kapena zingapo zachipatala m'thupi la munthu:

• Kuzindikira, kupewa, kuyang'anira, kulosera, kuneneratu, kuchiza kapena kukhululukidwa kwa matenda;
• Kuzindikira, kuyang'anira, chithandizo, chithandizo, ndi malipiro a kuvulala kapena kulumala;
• Kuphunzira, kulowetsa m'malo, ndikuwongolera machitidwe a anatomical, physiological, kapena pathological process;
• Perekani zidziwitso kudzera mu kuyesa kwa m'mimba kwa zitsanzo za thupi la munthu, kuphatikiza ziwalo, magazi, ndi minyewa yoperekedwa;
• Zomwe zimagwiritsidwa ntchito makamaka zimapezedwa mwakuthupi ndi njira zina, osati kudzera mu pharmacology, immunology, kapena metabolism, kapena ngakhale kuti njirazi zikukhudzidwa, zimangogwira ntchito yothandizira;
• Zipangizo zokhala ndi zowongolera kapena zothandizira
• Amagwiritsidwa ntchito mwapadera kuyeretsa, kuphera tizilombo toyambitsa matenda, kapena zida zoyezera.

Chipangizo chogwira ntchito

Chida chilichonse chomwe chimagwira ntchito ngati gwero lamphamvu kusiyapo kudalira thupi la munthu kapena mphamvu yokoka, ndipo chimagwira ntchito posintha kuchuluka kwa mphamvu kapena kutembenuza mphamvu.Zipangizo zomwe zimagwiritsidwa ntchito potumiza mphamvu, zinthu, kapena zinthu zina pakati pa zida zogwira ntchito ndi odwala popanda kusintha kwakukulu sizingaganizidwe ngati zida zogwira ntchito.

Chipangizo chosokoneza

Chida chilichonse chomwe chimadutsa m'thupi la munthu kudzera munjira zachilengedwe kapena malo.

Paketi ya ndondomeko

Kuphatikizika kwazinthu zophatikizidwa pamodzi ndikugulitsidwa pazifukwa zachipatala.

Wopanga

Munthu wachilengedwe kapena wovomerezeka yemwe amapanga kapena kukonzanso kwathunthu chipangizo chopangidwa, chopangidwa, kapena chokonzedwanso ndikugulitsa chipangizocho pansi pa dzina lake kapena chizindikiro chake.

Kukonzanso kwathunthu

Kutengera tanthauzo la wopanga, zikutanthauza kukonzanso kwathunthu kwa zida zomwe zidayikidwa pamsika kapena kugwiritsidwa ntchito, kapena kugwiritsa ntchito zida zomwe zidagwiritsidwa ntchito popanga zida zatsopano zomwe zimagwirizana ndi lamuloli ndikupatsanso zida zokonzedwanso moyo watsopano. 

Woyimira Wovomerezeka

Munthu aliyense wachilengedwe kapena wovomerezeka wodziwika mu EU yemwe amalandira ndikuvomera chilolezo cholembedwa kuchokera kwa wopanga yemwe ali kunja kwa EU kuti achitepo kanthu m'malo mwa wopanga molingana ndi zomwe zakhazikitsidwa ndi Lamuloli kwa wopanga.

Wolowetsa

Munthu aliyense wachilengedwe kapena wovomerezeka wodziwika mu European Union yemwe amayika zida zochokera kumayiko achitatu pamsika wa EU.

Ogawa

Munthu aliyense wachilengedwe kapena wovomerezeka mwa ogulitsa, kupatula wopanga kapena wotumiza kunja, akhoza kuyika chipangizocho pamsika mpaka chikagwiritsidwe ntchito.

Unique Device Identification (UDI)

Mndandanda wa zilembo za manambala kapena manambala opangidwa kudzera m'zidziwitso za zida zodziwika padziko lonse lapansi ndi miyezo yokhota, kulola kuti zidziwitso za zida zinazake pamsika.