Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications
Nebojsa Serafimovic
BASG - Austrian Federal Office…
Free
Critical Considerations in Site Selection and Subject Enrollment in Device and IVD Clinical Studies
Matteo Mosso
Donawa Lifescience, Italy
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
General Data Protection Regulations in the EU
Danielle Giroud
MD-Clinicals SA, Switzerland
Free
Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance
Maria Donawa
Member of the Board, EAAR,…
Free
Standards, Harmonisation Process and Common Specifications
Nils-Ã…ke Lindberg
Member of the Board, EAAR;…
Free
General Safety and Performance Requirements under the Medical Devices
Claire Murphy
EAAR Member of the Board,…
Free
Issues Arising from the Implementation of the IVD-Regulations
Maurizio Suppo
Member of the Board, EAAR,…
Free
Clinical Evaluation, Investigations and PMCF under MDR
Helene Quie
Member of the Board, EAAR,…
Free
Major Regulatory Compliance Challenges for the Non-European Industry
Mindy Mc Caan
VP Regulatory Compliance, Qserve Group,…
Free
Benefit Risk Assessment
Helene Quie
Member of the Board, EAAR,…
Free