Sylvain Fogola

Senior Software Project Manager @Avicenna.Ai

La Ciotat, FR

Expert in product lifecycle management and regulatory compliance for AI-enabled medical devices- Lead end-to-end product lifecycle management in compliance with ISO 14971, IEC 62304/82304, cybersecurity requirements and relevant regulatory standards- Collaborate closely with product management teams to conduct competitive analyses, define product specifications- Define project scope, goals, and deliverables, ensuring alignment with business objectives and regulatory frameworks- Develop and manage task and resource plans, optimizing team efficiency and meeting project milestones on time- Monitor progress through regular project follow-ups, ensuring timely issue resolution and continuous stakeholder communication- Author and maintain comprehensive technical documentation, ensuring compliance for both internal and external audits- Oversee clinical evaluation and software testing, ensuring global coherence of technical documentation- Lead successful FDA 510(k) and MDR (UE 2017/745) submissions, enabling timely product market entry- Manage partnerships by overseeing software integration projects from customer requirements gathering to final delivery across third-party platforms- Continuously monitor evolving regulatory standards in the U.S. and Europe to ensure compliance for AI-enabled medical devices

Polytech'Grenoble

Health Information Technology

GMED - LNE

SA14C/SA14 Medical device regulation in the USA and Canada

Université de Technologie de Compiègne

Medical devices and Regulatory Affairs : CE-marking

Université Grenoble Alpes

DEUG MIAS

Centre de résonance magnétique des sytèmes biologiques

Training to MR imaging (physics and sequences)

Université Grenoble Alpes

Master M2 - Artificial Intelligence for One Health

Nexialist

Usability and risk mangement for medical devices