Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications
Nebojsa Serafimovic
BASG - Austrian Federal Office…
29 Min
1 Lesson
Free
Critical Considerations in Site Selection and Subject Enrollment in Device and IVD Clinical Studies
Matteo Mosso
Donawa Lifescience, Italy
34 Min
1 Lesson
Free
Competent Authority Expectations and Management of Device Clinical Study Applications Under the MDR
Tom Melvin
Health Products Regulatory Authority (HPRA),…
22 Min
1 Lesson
Free
Developing Clinical Investigation and Performance Study Plans That Meet Regulatory and Operational Requirements
Daniela Karrer
Donawa Lifescience, Italy
46 Min
1 Lesson
Free
General Data Protection Regulations in the EU
Danielle Giroud
MD-Clinicals SA, Switzerland
27 Min
1 Lesson
Free
Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance
Maria Donawa
Member of the Board, EAAR,…
29 Min
1 Lesson
Free
MDR Requirements for Sponsor GCP Inspections (audits) and How to Conduct Them
Maria Donawa
Member of the Board, EAAR,…
45 Min
1 Lesson
Free
Standards, Harmonisation Process and Common Specifications
Nils-Åke Lindberg
Member of the Board, EAAR;…
29 Min
1 Lesson
Free
General Safety and Performance Requirements under the Medical Devices
Claire Murphy
EAAR Member of the Board,…
29 Min
1 Lesson
Free
Software, Artificial Intelligence and Cybersecurity in the European Union
Robert Ginsberg
EAAR Member of the Board,…
27 Min
1 Lesson
Free
Issues Arising from the Implementation of the IVD-Regulations
Maurizio Suppo
Member of the Board, EAAR,…
28 Min
1 Lesson
Free
Clinical Evaluation, Investigations and PMCF under MDR
Helene Quie
Member of the Board, EAAR,…
33 Min
1 Lesson
Free
Major Regulatory Compliance Challenges for the Non-European Industry
Mindy Mc Caan
VP Regulatory Compliance, Qserve Group,…
29 Min
1 Lesson
Free
Benefit Risk Assessment
Helene Quie
Member of the Board, EAAR,…
18 Min
1 Lesson
Free
