• 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)