Testing strategie definition

• Quality control and stability studies

• Preclinical evaluation

• Management of in vitro and in vivo toxicological tests (GLP) according to ISO 10993

Bibliographic clinical evaluation

• Clinical evaluation plan (CEP)

• Clinical evaluation report (CER)

• Post-market clinical follow-up plan (PMCF Plan)

• ​Post-market clinical follow-up report (PMCF Report)