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Online VOD

Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications

Nebojsa Serafimovic
Nebojsa Serafimovic
Duration 29 Min
About the Course

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

Matteo Mosso
Matteo Mosso
Duration 34 Min
About the Course

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

Tom Melvin
Tom Melvin
Duration 22 Min
About the Course

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

Daniela Karrer
Daniela Karrer
Duration 46 Min
About the Course

Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance

Maria Donawa
Maria Donawa
Duration 29 Min
About the Course

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

Maria Donawa
Maria Donawa
Duration 45 Min
About the Course

Standards, Harmonisation Process and Common Specifications

Nils-Åke Lindberg
Nils-Åke Lindberg
Duration 29 Min
About the Course

General Safety and Performance Requirements under the Medical Devices

Claire Murphy
Claire Murphy
Duration 29 Min
About the Course

Software, Artificial Intelligence and Cybersecurity in the European Union

Robert Ginsberg
Robert Ginsberg
Duration 27 Min
About the Course

Issues Arising from the Implementation of the IVD-Regulations

Maurizio Suppo
Maurizio Suppo
Duration 28 Min
About the Course

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