Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications

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

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

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

Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance

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

Standards, Harmonisation Process and Common Specifications

General Safety and Performance Requirements under the Medical Devices

Software, Artificial Intelligence and Cybersecurity in the European Union

Issues Arising from the Implementation of the IVD-Regulations