Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications
Nebojsa Serafimovic
BASG - Austrian Federal Office…
Free
Competent Authority Expectations and Management of Device Clinical Study Applications Under the MDR
Tom Melvin
Health Products Regulatory Authority (HPRA),…
Free
Developing Clinical Investigation and Performance Study Plans That Meet Regulatory and Operational Requirements
Daniela Karrer
Donawa Lifescience, Italy
Free
Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance
Maria Donawa
Member of the Board, EAAR,…
Free
MDR Requirements for Sponsor GCP Inspections (audits) and How to Conduct Them
Maria Donawa
Member of the Board, EAAR,…
Free
Standards, Harmonisation Process and Common Specifications
Nils-Ã…ke Lindberg
Member of the Board, EAAR;…
Free
Software, Artificial Intelligence and Cybersecurity in the European Union
Robert Ginsberg
EAAR Member of the Board,…
Free
Issues Arising from the Implementation of the IVD-Regulations
Maurizio Suppo
Member of the Board, EAAR,…
Free