Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications
29 Min
1 Lesson
$80 Per person
Competent Authority Expectations and Management of Device Clinical Study Applications Under the MDR
22 Min
1 Lesson
$70 Per person
Developing Clinical Investigation and Performance Study Plans That Meet Regulatory and Operational Requirements
46 Min
1 Lesson
$75 Per person
Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance
29 Min
1 Lesson
$75 Per person
MDR Requirements for Sponsor GCP Inspections (audits) and How to Conduct Them
45 Min
1 Lesson
$70 Per person
Standards, Harmonisation Process and Common Specifications
29 Min
1 Lesson
$75 Per person
Software, Artificial Intelligence and Cybersecurity in the European Union
27 Min
1 Lesson
$75 Per person
Issues Arising from the Implementation of the IVD-Regulations
28 Min
1 Lesson
$80 Per person
