{"id":6524,"date":"2026-04-21T09:55:09","date_gmt":"2026-04-21T09:55:09","guid":{"rendered":"https:\/\/www.medgeneraction.it\/program\/"},"modified":"2026-07-30T16:25:42","modified_gmt":"2026-07-30T16:25:42","slug":"program","status":"publish","type":"page","link":"https:\/\/www.medgeneraction.it\/en\/program\/","title":{"rendered":"Program"},"content":{"rendered":"

September 30: <\/strong>Round Table<\/h2><\/div>

Speeches by stakeholders (Regulatory Authorities, Notified Bodies and Agencies).<\/h4><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
08:00 – 09:15 AM<\/h5><\/div><\/div><\/div>
Participant Registration & Networking<\/div><\/div><\/div><\/div><\/div><\/div>
9:15 AM – 9:30 AM<\/b><\/h5><\/div><\/div><\/div>
Opening Remarks<\/div><\/div><\/div><\/div><\/div><\/div>
9:30 AM – 10:30 AM<\/strong><\/h5><\/div><\/div><\/div>
MDR Today and Tomorrow: Governance, Priorities and Next Steps<\/div><\/div>

Armando Romaniello<\/strong> \u2013 Certiquality
Alessia Frabetti<\/strong> \u2013 KIWA Cermet Italia
Alessandra Basilisco<\/strong> \u2013 Ministero della Salute Italiana
Sarah Parrettini<\/strong> \u2013 IMQ
Linda Sanin<\/strong> \u2013 Promunidi
Federica Giovetti<\/strong> \u2013 Citieffe<\/p>\n<\/div>

<\/h4><\/div><\/div><\/div><\/div><\/div>
10:30 – 11:00 AM<\/strong><\/h5><\/div><\/div><\/div>
Questions, answers and discussion<\/div><\/div><\/div><\/div><\/div><\/div>
11:00 AM – 11:30 AM<\/strong><\/h5><\/div><\/div><\/div>
Coffee Break & Networking<\/div><\/div><\/div><\/div><\/div><\/div>
11:30 AM – 12:30 PM<\/strong><\/h5><\/div><\/div><\/div>
New Technologies, New Rules: AI and the Next Regulatory Frontier<\/span><\/div><\/div>

<\/h4><\/div>

Elisa Veronese<\/strong> \u2013 T\u00dcV S\u00dcD Italia
Massimiliano Testi<\/strong> \u2013 T\u00dcV Rheinland Italia 
Sara Crocetti<\/strong> \u2013 Bureau Veritas
Piet De Jong<\/strong> \u2013 Cosmo Health Confidence
Flavia Pirovano<\/strong> \u2013 MedTech Europe
Mario Federighi<\/strong> \u2013 Farmigea<\/p>\n<\/div><\/div><\/div><\/div><\/div>

12:30 PM – 1:00 PM<\/strong><\/h5><\/div><\/div><\/div>
Questions, answers and discussion<\/div><\/div><\/div><\/div><\/div><\/div>
h 13.00 – 14.30<\/strong><\/h5><\/div><\/div><\/div>
Lunch & Networking<\/div><\/div><\/div><\/div><\/div><\/div>
2:30 PM – 3:30 PM<\/strong><\/h5><\/div><\/div><\/div>
IVDR Focus: Readiness, Evidence and Notified Body Expectations<\/div><\/div>

<\/h4><\/div>

Eva Camatini<\/strong> \u2013 IMQ 
Angela Candido<\/strong> \u2013 Istituto Superiorire di Sanit\u00e0 (ISS)
Livio Riitto<\/strong> \u2013 DNV
Emily Malmberg<\/strong> \u2013 K2C
Sean O\u2019Callaghan<\/strong> \u2013 BSI<\/p>\n<\/div><\/div><\/div><\/div><\/div>

3:30 PM – 4:00 PM<\/strong><\/h5><\/div><\/div><\/div>
Questions, answers and discussion<\/div><\/div><\/div><\/div><\/div><\/div>
4:00 PM – 4:30 PM<\/strong><\/h5><\/div><\/div><\/div>
Coffee Break & Networking<\/div><\/div><\/div><\/div><\/div><\/div>

September 30: <\/strong>Technical Sessions<\/h2><\/div>
in person or via live streaming<\/h6>\n<\/div>

with the participation of Regulatory Authorities, Notified Bodies, service providers and industry<\/h4><\/h4><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
4:30 PM – 6:00 PM<\/strong><\/h5><\/div><\/div><\/div>
SESSION A<\/strong><\/h5><\/div>
Performance Evaluation under IVDR: From Data to Compliance<\/span><\/div><\/div><\/div><\/div>
SESSION B<\/strong><\/h5><\/div>
MDSAP: Building a Single QMS for Multiple Jurisdictions<\/span><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
8:00 PM – 11:00 PM<\/strong><\/h5><\/div><\/div><\/div>
Networking Dinner<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>

October 1: <\/strong>Technical Sessions<\/h2><\/div>

with the participation of Regulatory Authorities, Notified Bodies, service providers and industry<\/h4><\/h4><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
9:00 AM – 10:45 AM<\/strong><\/h5><\/div><\/div><\/div>
SESSION A <\/h5><\/div>
Risk Management: Common Pitfalls and Best Practices<\/span><\/div><\/div><\/div><\/div>
SESSION B<\/h5><\/div>
Market Access: Comparing EU and Extra-EU Documentation Pathways<\/span><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
10:45 AM – 11:15 AM<\/strong><\/h5><\/div><\/div><\/div>
Coffee Break & Networking<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
11:15 AM – 1:00 PM<\/strong><\/h5><\/div><\/div><\/div>
SESSION A<\/h5><\/div>
Communication & Claims in MedTech: Compliance and Enforcement<\/span><\/div><\/div><\/div><\/div>
SESSION B<\/h5><\/div>
Testing Strategy: Regulatory Acceptance of Tests with a Global Perspective<\/span><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>
End of event<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div>

Book your place at MDG Health Matters now<\/p><\/h4><\/div>

<\/h4><\/div><\/div><\/div>
Ticket<\/span><\/a><\/div><\/div><\/div>
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