Medicinski pripomočki

illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.

Medicinski pripomočki

STORITVE

  • Skladnost s smernicami sistema vigilance za medicinske pripomočke
  • Storitev osebe, ki je pristojna za skladnost z zakonodajo (PRRC)
  • Vzpostavitev sistema kakovosti ter usposabljanje osebja
  • Sistem nadzora po dajanju na trg
  • Ocena zapletov in dogodkov 
  • Poročanje o zapletih in drugih dogodkih
  • Priprava in poročanje varnostnih korektivnih ukrepov (FSCA)
  • Priprava obvestil o varnostnem korektivnem ukrepu (FSN)
  • Priprava rednih posodobljenih poročil o varnosti
  • Vzpostavitev ustreznih pogodbenih dogovorov ter nadzor
  • Presoje in svetovanje pred inšpekcijskimi nadzori
illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
medicine

I think it is quite remarkable how we as humans have improved in the pharmaceutical and medical fields in the last 100 years. I am sure that we will remain courageous and continue to innovate!

Martina

Božíková

MASTER'S in PHARMACY REGULATORY AFFAIRS & PHARMACOVIGILANCE OFFICER