Den nya medicintekniska förordningen (MDR) innebär att den regulatoriska kartan för mjukvaruprodukter ritas om. Regelverket ska tillämpas från och med den 26:e maj 2020 och får en påverkan på de flesta medicintekniska mjukvaruprodukter och nationella medicinska informationssystem. En ny vägledning för tillverkare har tagits fram av EU. Vägledningen är tänkt att fungera som en guide för klassificering och kvalificering av mjukvaruprodukter. Föreläsningen kommer att ge en inblick i hur en tillverkare med hjälp av vägledningen och regelverket kan besvara följande frågor: •Är min produkt en medicinteknisk produkt? •Vilken riskklass tillhör min produkt? •Vilken konsekvens får detta regulatoriskt för min produkt?
Senior Clinical Development Expert Symbioteq Kvalitet AB
Johanna har doktorsexamen från KTH och har en bred erfarenhet från life science-fältet bland annat från produktutveckling av in vitro diagnostiska produkter. Som konsult på Symbioteq har Johanna erfarenhet av att arbeta med tillverkare av medicinska informationssystem med teknisk dokumentation och kvalitetsledning och har också arbetat med tillverkning av högriskprodukter. I uppdragen har Johanna dessutom arbetat som QA / RA-chef för legala tillverkare samt hållit utbildningar inom kvalitetsledning och riskhantering.
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