Antti Valanne
Regulatory Manager
Sertio Oy
Finland
Education: PhD in biotechnology (in vitro diagnostics), clinical biochemist; Experience: Regulatory affairs work at an IVD manufacturer, sales and marketing at an IVD distributor; Current work: technical documentation assessor, auditor/lead auditor, internal clinician.
Aiheet
Notified body's perspective to IVD performance studies
Clinical Evidence Generation
IVD
5.2.2026 13:30 - 14:10 | Hall 209
Expectations and observations of a notified body in regards to (IVD) performance study activities.