In recent years, the number of medical devices designed to be used  within a home environment has increased substantially; this is why it has been necessary the introduction of a

The evaluation of the cytotoxicity of a medical device based on ISO 10993 is one of the key milestone for the introduction of new devices on the market, thus

Introduction to Verification vs Validation Design verification and validation are critical components of the design process when developing a medical device. It is vital to have a clear understanding of

Introduction of 21 CFR Part 11 Requirements FDA 21 CFR Part 11 defines the requirements for the management of electronic records and electronic signatures. It is one among the best known

Biocompatibility evaluation according to ISO 10993-1 and the related biological risk assessment is one of the most important validation activities for medical device. It is an important process during the