Picture Of Nebojsa Serafimovic
Nebojsa Serafimovic
Course Time 29 Min

Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications

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 Maria Donawa
Maria Donawa
Course Time 45 Min

MDR Requirements for Sponsor GCP Inspections (audits) and How to Conduct Them

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

Standards, Harmonisation Process and Common Specifications

Picture Of Robert Ginsberg
Robert Ginsberg
Course Time 27 Min

Software, Artificial Intelligence and Cybersecurity in the European Union

Picture Of Maurizio Suppo
Maurizio Suppo
Course Time 28 Min

Issues Arising from the Implementation of the IVD-Regulations