11:40 am - 12:15 pm
Workshop Room 2
Labs

INSIDE THE TALK

AI-Powered SDLC Management for Compliant Healthcare Software

P4SaMD as Quality Assistant for a Medical Device Development

Quality Assistant is an AI-powered tool designed to address the complexities of software development in highly regulated industries. It streamlines the entire Software Development Life Cycle (SDLC), guiding teams from specification definition through controlled product release. The tool offers continuous, automatic detection of implementation against design, alongside comprehensive identification of dependencies and vulnerabilities. AI-powered evaluation features provide suggestions for achieving high-quality specifications and ensure maximum test coverage. Along with seamless integration of ALM, it simplifies traceability supporting compliance and providing the complete documentation set. Quality Assistant enables the manufacture of compliant, high-quality software, ultimately reducing time-to-market and development bottlenecks. It found its first application in the healthcare realm as Platform 4 Software as a Medical Device (P4SaMD), allowing the compliance with IEC 62304 and emerging AI regulations and guidelines (AI Act, FDA, IMDRF).
LANGUAGE
English
FORMAT
Live Demo

SPEAKERS

Speaker
Roberta Egoriti
Product Owner
@Mia-Care
Speaker
Davide Calabrò
Senior Tech Leader
@Mia-Care
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