Development Phase

  • Identification of quality and safety attributes (QbD)
  • Development, characterization and optimization of prototypes.
  • In vitro preclinical tests to perform an initial assessment of the efficacy and safety of the medical device
  • Development of in vivo preclinical testing (safety & efficacy assessment)
  • Optimization of the prototype and manufacturing process with the help of the in vitro assays
  • Identification of critical material & process attributes(QbD)