September 30: Round Table
Speeches by stakeholders (Regulatory Authorities, Notified Bodies and Agencies).
08:00 – 09:15 AM
Participant Registration & Networking
9:15 AM – 9:30 AM
Opening Remarks
9:30 AM – 10:30 AM
MDR Today and Tomorrow: Governance, Priorities and Next Steps
Armando Romaniello – Certiquality
Alessia Frabetti – KIWA Cermet Italia
Alessandra Basilisco – Ministero della Salute Italiana
Sarah Parrettini – IMQ
Linda Sanin – Promunidi
Federica Giovetti – Citieffe
10:30 – 11:00 AM
Questions, answers and discussion
11:00 AM – 11:30 AM
Coffee Break & Networking
11:30 AM – 12:30 PM
New Technologies, New Rules: AI and the Next Regulatory Frontier
Elisa Veronese – TÜV SÜD Italia
Massimiliano Testi – TÜV Rheinland Italia
Sara Crocetti – Bureau Veritas
Piet De Jong – Cosmo Health Confidence
Flavia Pirovano – MedTech Europe
Mario Federighi – Farmigea
12:30 PM – 1:00 PM
Questions, answers and discussion
h 13.00 – 14.30
Lunch & Networking
2:30 PM – 3:30 PM
IVDR Focus: Readiness, Evidence and Notified Body Expectations
Eva Camatini – IMQ
Angela Candido – Istituto Superiorire di Sanità (ISS)
Livio Riitto – DNV
Emily Malmberg – K2C
Sean O’Callaghan – BSI
3:30 PM – 4:00 PM
Questions, answers and discussion
4:00 PM – 4:30 PM
Coffee Break & Networking
September 30: Technical Sessions
in person or via live streaming
with the participation of Regulatory Authorities, Notified Bodies, service providers and industry
4:30 PM – 6:00 PM
SESSION A
Performance Evaluation under IVDR: From Data to Compliance
SESSION B
MDSAP: Building a Single QMS for Multiple Jurisdictions
8:00 PM – 11:00 PM
Networking Dinner
October 1: Technical Sessions
with the participation of Regulatory Authorities, Notified Bodies, service providers and industry
9:00 AM – 10:45 AM
SESSION A
Risk Management: Common Pitfalls and Best Practices
SESSION B
Market Access: Comparing EU and Extra-EU Documentation Pathways
10:45 AM – 11:15 AM
Coffee Break & Networking
11:15 AM – 1:00 PM
SESSION A
Communication & Claims in MedTech: Compliance and Enforcement
SESSION B
Testing Strategy: Regulatory Acceptance of Tests with a Global Perspective
End of event
