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Medicinski pripomočki bodo odslej varnejši

Nove zahteve na več področjih
Za uporabnika bodo izdelki varnejši in bolj bo preverjeno njihovo delovanje, še pove Ana Pribaković Borštnik in doda, da bodo do 24. maja 2024 celotne postopke ponovnega certificiranja morali prestati vsi medicinski pripomočki, če jih bo proizvajalec še želel dajati na trg.« Velik poudarek je na dokazovanju učinkov delovanja, uredba dodaja tudi nove zahteve glede varnosti in učinkovitosti medicinskega pripomočka, poudarjena je varnost programske opreme. Uredba uvaja tudi zahteve glede kibernetske varnosti.«
Pooblaščene certifikatske agencije v ponovno imenovanje
Od 26. maja morajo vsi proizvajalci medicinskih pripomočkov ne glede na razred tveganja in ne glede na to, ali so certificirani po novi uredbi ali stari direktivi, izpolnjevati zahteve nove uredbe za vigilanco in poprodajno spremljanje, pojasnjuje Ana Pribaković Borštnik, pomočnica direktorja področja ocenjevanja sistemov vodenja za področje medicinskih pripo ....

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Jorge Levinson, directorul diviziei Bayer Pharmaceuticals România şi Moldova: Mulţi pacienţi s-au temut să iasă din casă pentru o vizită la medic, ceea ce a însemnat o aderenţă foarte scăzută la tratamentele medicale

Jorge Levinson, directorul diviziei Bayer Pharmaceuticals România şi Moldova: Mulţi pacienţi s-au temut să iasă din casă pentru o vizită la medic, ceea ce a însemnat o aderenţă foarte scăzută la tratamentele medicale
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Corona bei Maischberger: Spahn lässt wichtige Frage offen - Virologin und Siemens-Chef warnen drastisch

Corona bei Maischberger: Spahn lässt wichtige Frage offen - Virologin und Siemens-Chef warnen drastisch
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