Picture Of Anat Sakov
Anat Sakov
Course Hours 04 June 2024

Sample Size Selection in a Clinical Trial

Picture Of Johann Daniel Weyer
Johann Daniel Weyer
Course Hours 16 May 2024

Data Management for Non-Data Managers

Picture Of Joseph Tyler
Joseph Tyler
Course Hours 19 June 2024

Best Practices for CMC Section Preparation for IND’s and IMPD’s

Picture Of Ady Banin
Ady Banin
Course Hours 31 January 2024

Introduction to AI-integrated Medical Devices Regulatory Compliance

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 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 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