Tababarka Hitec Medical MDR - Qeexida Shuruudaha MDR

Qalabka caafimaadka

Waxa loola jeedaa qalab kasta, qalab, qalab, software, implant, reagent, walxo, ama shay kasta oo loo isticmaalo kaligiis ama isku darka soo saaraha mid ama ka badan oo ujeedooyin caafimaad oo gaar ah ee jidhka bini'aadamka:

• ogaanshaha, ka hortagga, la socodka, saadaalinta, saadaasha, daaweynta ama cafiska cudurada;
• ogaanshaha, la socodka, daaweynta, gargaarka, iyo magdhowga dhaawacyada ama naafada;
• Daraasadda, beddelka, iyo habaynta hababka anatomical, physiological, ama pathological hababka ama gobolada;
• Ku bixi macluumaadka iyada oo loo marayo baadhista in vitro ee shaybaarada jidhka bini'aadamka, oo ay ku jiraan xubnaha, dhiigga, iyo unugyada la deeqay;
• Isticmaalkeeda waxaa inta badan lagu helaa qaab jireed iyo siyaabo kale, oo aan lagu helin farmasiyada, immunology, ama dheef-shiid kiimikaad, ama in kasta oo hababkan ay ku lug leeyihiin, kaliya waxay ciyaaraan door caawimo ah;
• Aaladaha leh kontoroolka ama ujeedooyinka taageerada
• Si gaar ah loo isticmaalo nadiifinta, jeermiska dila, ama qalabka jeermiska lagu nadiifiyo.

Aalad firfircoon

Qalab kasta oo u shaqeeya sida ilo tamar oo aan ahayn ku tiirsanaanta jidhka bini'aadamka ama cuf-jiidadka, oo u shaqeeya beddelka cufnaanta tamarta ama beddelka tamarta.Aaladaha loo isticmaalo gudbinta tamarta, walxaha, ama walxaha kale ee udhaxeeya aaladaha firfircoon iyo bukaanka iyada oo aan wax isbedel ah la taaban karin looma tixgelin doono qalab firfircoon.

Aalad soo galeysa

Qalab kasta oo jidhka bini'aadamka ka soo gala kanaalada dabiiciga ah ama dusha sare.

Xidhmada habraaca

Isku darka alaabooyinka la isku daray oo la suuq geeyey ujeedooyin caafimaad oo gaar ah.

Soo saaraha

Qofka dabiiciga ah ama sharciga ah ee soo saara ama si buuxda u dib u hagaajiya qalab ama qalab loogu talagalay, la sameeyay, ama si buuxda u cusboonaysiiyay oo ku iibiya aaladda magaciisa ama calaamadda ganacsiga.

Dib u habayn buuxda

Iyadoo lagu salaynayo qeexida soo saaraha, waxa ay tilmaamaysaa dib u habayn dhamaystiran oo lagu sameeyay agabka suuqa la galiyay ama la isticmaalay,ama adeegsiga aaladaha la isticmaalay si loo soo saaro aalado cusub oo u hogaansama xeerkan oo siiya aaladaha la dayactiray cimri cusub. 

Wakiil idman

Qof kasta oo dabiici ah ama sharci ah oo lagu aqoonsaday gudaha EU kaas oo ka qaata oo aqbala ogolaanshaha qoran ee soo saaraha ku yaal meel ka baxsan Midowga Yurub si uu u qaado dhammaan talaabooyinka isagoo matalaya soo saaraha si waafaqsan waajibaadka uu soo rogay Xeerkan soo saaraha.

Soodejiye

Qof kasta oo dabiici ah ama sharci ah oo lagu aqoonsaday gudaha Midowga Yurub kaasoo dhigaya aaladaha wadamada saddexaad suuqa EU.

Qaybiyayaal

Qof kasta oo dabiici ah ama sharci ah oo ka mid ah alaab-qeybiyaha, oo aan ahayn soo-saaraha ama soo-dejiye, waxa uu dhigi karaa aaladda suuqa ilaa inta la isticmaalayo.

Aqoonsiga Qalabka Gaarka ah (UDI)

Taxane xarfo tiro ama alifnumeric ah oo lagu sameeyay aqoonsiga aaladaha iyo heerarka koodka ee caalamiga ah, taasoo u oggolaanaysa in si cad loo aqoonsado aaladaha gaarka ah ee suuqa.