Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications

Nebojsa Serafimovic
Nebojsa Serafimovic
BASG - Austrian Federal Office…
Course Time 29 Min
Lessons 1 Lesson

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

Matteo Mosso
Matteo Mosso
Donawa Lifescience, Italy
Course Time 34 Min
Lessons 1 Lesson

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

Tom Melvin
Tom Melvin
Health Products Regulatory Authority (HPRA),…
Course Time 22 Min
Lessons 1 Lesson

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

Daniela Karrer
Daniela Karrer
Donawa Lifescience, Italy
Course Time 46 Min
Lessons 1 Lesson

General Data Protection Regulations in the EU

Danielle Giroud
Danielle Giroud
MD-Clinicals SA, Switzerland
Course Time 27 Min
Lessons 1 Lesson

Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance

Maria Donawa
Maria Donawa
Member of the Board, EAAR,…
Course Time 29 Min
Lessons 1 Lesson

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

Maria Donawa
Maria Donawa
Member of the Board, EAAR,…
Course Time 45 Min
Lessons 1 Lesson

Standards, Harmonisation Process and Common Specifications

Nils-Åke Lindberg
Nils-Åke Lindberg
Member of the Board, EAAR;…
Course Time 29 Min
Lessons 1 Lesson

General Safety and Performance Requirements under the Medical Devices

Claire Murphy
Claire Murphy
EAAR Member of the Board,…
Course Time 29 Min
Lessons 1 Lesson

Software, Artificial Intelligence and Cybersecurity in the European Union

Robert Ginsberg
Robert Ginsberg
EAAR Member of the Board,…
Course Time 27 Min
Lessons 1 Lesson

Issues Arising from the Implementation of the IVD-Regulations

Maurizio Suppo
Maurizio Suppo
Member of the Board, EAAR,…
Course Time 28 Min
Lessons 1 Lesson

Clinical Evaluation, Investigations and PMCF under MDR

Helene Quie
Helene Quie
Member of the Board, EAAR,…
Course Time 33 Min
Lessons 1 Lesson

Major Regulatory Compliance Challenges for the Non-European Industry

Mindy Mc Caan
Mindy Mc Caan
VP Regulatory Compliance, Qserve Group,…
Course Time 29 Min
Lessons 1 Lesson

Benefit Risk Assessment

Helene Quie
Helene Quie
Member of the Board, EAAR,…
Course Time 18 Min
Lessons 1 Lesson