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Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
RAPS Focus
RAPS Focus
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Networking Opportunity
Ticketed Event
Ticketed Event
Student Focus
Student Focus

Luigi Cipolleschi, Dott.

Quality Manager / RA Specialist
Biochemical Systems International S.p.A.
Arezzo, Toscana, Italy

Quality Assurance Manager with over eight years of experience in the biomedical and in vitro diagnostics (IVD) sector. Currently responsible for the management and continuous improvement of the Quality Management System in compliance with ISO 13485 and IVDR requirements.

Experienced in regulatory compliance, post-market surveillance, risk management, and technical documentation for in vitro diagnostic medical devices. Actively involved in MDR and IVDR transition activities, including gap analysis, performance evaluation planning, and interactions with notified bodies.

Skilled in quality audits, supplier management, complaint handling systems, and implementation of electronic Quality Management Systems (eQMS). Strong focus on regulatory strategy, product lifecycle management, and continuous professional development through specialized training in IVDR and medical device regulations.

Interested in regulatory affairs, quality systems optimization, and innovation in diagnostic technologies, with a long-term goal of supporting companies through regulatory and quality consulting in the medical device sector.

Presentation(s):

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