IVD Bio Courses – BioAcademy

Picture Of Ady Banin

31 January 2024

Introduction to AI-integrated Medical Devices Regulatory Compliance

live

LIVE

About the Course

Picture Of Nebojsa Serafimovic

Nebojsa Serafimovic

Course Time

29 Min

Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications

VOD

About the Course

Picture Of Matteo Mosso

Course Time

34 Min

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

VOD

About the Course

Picture Of Tom Melvin

Course Time

22 Min

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

VOD

About the Course

Picture Of Daniela Karrer

Course Time

46 Min

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

VOD

About the Course

Picture Of Maria Donawa

Course Time

29 Min

Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance

VOD

About the Course

Picture Of Maria Donawa

Course Time

45 Min

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

VOD

About the Course

Picture Of Nils-Åke Lindberg

Nils-Åke Lindberg

Course Time

29 Min

Standards, Harmonisation Process and Common Specifications

VOD

About the Course

Picture Of Claire Murphy

Course Time

29 Min

General Safety and Performance Requirements under the Medical Devices

VOD

About the Course

Picture Of Robert Ginsberg

Robert Ginsberg

Course Time

27 Min

Software, Artificial Intelligence and Cybersecurity in the European Union

VOD

About the Course

Picture Of Maurizio Suppo

Course Time

28 Min

Issues Arising from the Implementation of the IVD-Regulations

VOD

About the Course

Picture Of Helene Quie

Course Time

33 Min

Clinical Evaluation, Investigations and PMCF under MDR

VOD

About the Course

Picture Of Mindy Mc Caan

Course Time

29 Min

Major Regulatory Compliance Challenges for the Non-European Industry

VOD

About the Course

Picture Of Helene Quie

Course Time

18 Min

Benefit Risk Assessment

VOD

About the Course