Joytech Medical EU Quality Management System Certificate (MDR) a TüVSüD SÜD de maeɛ wɔ April 28, 2022. Adansedie no dodoɔ bi ne: Wɔmaa dijitaal ɔhyew kyerɛwtohɔ, mogya mmoroso ho nhwehwɛmu, infrared aso thermometer, infrared moma so thermometer, multifunction moma so thermometer , anyinam ahoɔden nufu pɔmpɛ, nsaano nufu pɔmpɛ. Ɛyɛ nnwumakuw a wodii kan nyaa CE a wodi so adansedi krataa wɔ mmara foforo MDR ahwehwɛde ahorow ase no mu biako, na ɛyɛ MDR adansedi krataa a edi kan ma afie mu ɛlɛtrɔnik thermometers, infrared aso thermometers ne nufu pɔmpɛ.
Joytech Medical yɛ a
EU de nkakrankakra rekyekye ayɛ gua kɛse a wɔaka abom de ayi aguadi mu akwanside ahorow a ɛda aman a wɔka ho no ntam afi hɔ na wɔahwɛ ahu sɛ nnipa, nnwuma, kapital ne nneɛma (te sɛ nnuruyɛ mfiri) bɛkɔ baabiara a wontua hwee. Wɔ nnuruyɛ mfiri ho no, Europa Bagua no ayɛ EU akwankyerɛ abiɛsa a wɔde besi aman a wɔka ho no mu biara mfitiase nhyehyɛe a wɔde gye tom no ananmu, sɛnea ɛbɛyɛ a wobetumi ayɛ mmara a ɛfa nneɛma a ɛtete saa a wɔtɔn ho no ahyia.
EU MDR no kyerɛ Aduruyɛ Mfiri ho Mmara (MDR) a ɛyɛ aban de a EU de ama (Aduruyɛ Mfiri Mmara (EU) 2017/745), a egyina MDR no Ahyɛdeɛ 123 no ahwehwɛdeɛ so. MDR no hyɛɛ aseɛ yɛɛ adwuma wɔ May 26, 2017 na ɛde kan Aduruyɛ Mfiri Akwankyerɛ (MDD 93/42/EEC) ne Active Medical Device Directive (AEDD) si ananmu wɔ aban kwan so firi May 26, 2020 , Implantable Medical Devices Directive (AIMDD 90/385/EEC).
Sɛ wɔde toto Medical Device Directive (MDD) ho a, MDR no yɛ katee wɔ asiane a ɛfa nneɛma a wɔyɛ ho, nneɛma no adwumayɛ ne ahobammɔ gyinapɛn, ayaresabea nhwehwɛmu, ne ani a wɔhwɛ wɔ gua akyi ne nneɛma a wɔhwɛ so. Ɛsan nso yɛ asɛnnennen kɛse ma nea ɔyɛ no nhyehyɛe a wɔde hwɛ nneɛma pa so ne nneɛma a wɔyɛ no ahobammɔ a etu mpɔn no.
MDR adansedie a ɛdi mu no kyerɛ Joytech Medical nneɛma a ɛkorɔn ne ne su ne EU gua a wɔgye tom. Joytech Medical bɛfa MDR CE adansedie no sɛ nkɔsoɔ hokwan foforɔ a ɛbɛma wiase nyinaa gua nhyehyɛeɛ no akɔ akyiri na aboa wiase nyinaa aduruyɛ adwuma.
