Liquidweb and Assobiomedica for the process of software certification

Liquidweb and Assobiomedica for the process of software certification

The seminar, promoted by Liquidweb s.r.l. and Assobiomedica, was inspired by the rapid proliferation and increasing pervasiveness of software within the field of medical devices (personal computers, smartphones, apps and finally the so-called wearable devices ‘wearables’) and national health systems.

However, the current application of rules and controls is not always able to address the particular risks to health resulting from a software intended as medical device (SAMD) nor to ensure an appropriate balance between the protection of the patient / consumer and the promotion of public health, while facilitating innovation.
The meeting took place as a tool to support innovation and timely access to safe and effective software market as a global medical devices, providing the opportunity to identify operational similarities and develop a common approach to proper controls, so how to promote the convergence perspective and regulatory stability in the areas of innovative technologies.

“GdL Certification Software Risk SW Lifecicle” (pdf)

“Software 16 February 2016_file audio” (mp3)

 

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