Tipo di tesi
Tesi di laurea magistrale
Titolo
Study and implementation of market regulatory pathways for BellaSeno products and preliminary mechanical simulation studies on bone cage structures for bone regeneration
Dipartimento
INGEGNERIA DELL'INFORMAZIONE
Corso di studi
INGEGNERIA BIOMEDICA
Riassunto (Italiano)
This work of thesis could be divided into two main parts.
The first part concerns the documentation needed for the HUD/HDE (for the Pectus Scaffold) designation, with a particular focus on the population estimate, and the 510(k) (concerning a medical device for long bone defect) designation for the premarket submission on FDA.
In the second part, the software Rhino was used to generate a code (with the plug in Grasshopper) that allow to design automatically different size of Bone cage structures with diamond shape just setting the input parameters. A parametric study was performed with the software ANSYS with whom a simulated compression of 5 mm was applied on the structures designed.
Another code was used to generate structure with different external shape also.
