Amahugurwa ya Hitec Medical MDR - Ibisabwa bya tekiniki bisabwa muri MDR (Igice cya 1)
| Ibigize | Ibirimo |
| Ibisobanuro byibikoresho, birimo software hamwe nibindi bikoresho | Ibisobanuro rusange byibicuruzwa, harimo kubikoresha no kubikoresha;UDI;ibimenyetso no kubirwanya;amabwiriza yo gukoresha;ibisabwa umukoresha;gutondekanya ibicuruzwa;urutonde rw'icyitegererezo;ibisobanuro bifatika;n'ibipimo ngenderwaho. |
| Amakuru yatanzwe nuwabikoze | Ibirango kubicuruzwa no kubipakira, amabwiriza yo gukoresha.(Koresha ururimi rwemewe n’ibihugu bigize Umuryango aho igikoresho kigenewe kugurishwa) |
| Gushushanya no gukora amakuru | Ibisobanuro byuzuye nibisobanuro kugirango usobanukirwe nicyiciro cyibishushanyo mbonera, uburyo bwo gukora no kwemeza, guhora ukurikirana no kugerageza ibicuruzwa byanyuma. Menya urubuga aho ibikorwa byo gushushanya no gukora bizabera, harimo naba rwiyemezamirimo. |
| Ibikorwa rusange byumutekano bisabwa GSPR | Ibisobanuro byerekana umutekano rusange nibisabwa mubikorwa kumugereka wa I;ikubiyemo gutsindishirizwa, kwemeza no kugenzura ibisubizo byemejwe kugirango byuzuze ibisabwa. |
| Isesengura ry'inyungu-nyungu no gucunga ibyago | Isesengura ry'inyungu n'ingaruka zo gucunga ibyago biri kumugereka I. |
| Kwemeza ibicuruzwa no kugenzura | Igomba kuba irimo ibisubizo nisesengura ryibanze ryigenzura no kwemeza ibizamini / ubushakashatsi bwakozwe |
Ibirango bisabwa muri MDR
Igihe cyo kohereza: Ukuboza-29-2023