Picture Of Nebojsa Serafimovic
Nebojsa Serafimovic
Course Time 29 Min

Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications

Picture Of Matteo Mosso
Matteo Mosso
Course Time 34 Min

Critical Considerations in Site Selection and Subject Enrollment in Device and IVD Clinical Studies

Picture Of Tom Melvin
Tom Melvin
Course Time 22 Min

Competent Authority Expectations and Management of Device Clinical Study Applications Under the MDR

Picture Of Daniela Karrer
Daniela Karrer
Course Time 46 Min

Developing Clinical Investigation and Performance Study Plans That Meet Regulatory and Operational Requirements

Picture Of Maria Donawa
Maria Donawa
Course Time 29 Min

Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance

Picture Of Nils-Åke Lindberg
Nils-Åke Lindberg
Course Time 29 Min

Standards, Harmonisation Process and Common Specifications

Picture Of Claire Murphy
Claire Murphy
Course Time 29 Min

General Safety and Performance Requirements under the Medical Devices

Picture Of Maurizio Suppo
Maurizio Suppo
Course Time 28 Min

Issues Arising from the Implementation of the IVD-Regulations

Picture Of Helene Quie
Helene Quie
Course Time 33 Min

Clinical Evaluation, Investigations and PMCF under MDR

Picture Of Mindy Mc Caan
Mindy Mc Caan
Course Time 29 Min

Major Regulatory Compliance Challenges for the Non-European Industry

Picture Of Helene Quie
Helene Quie
Course Time 18 Min

Benefit Risk Assessment