First Course
Nebojsa Serafimovic
16-17.06.23
1 Session
$100 Per person
Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications
29 Min
1 Lesson
$80 Per person
Critical Considerations in Site Selection and Subject Enrollment in Device and IVD Clinical Studies
34 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
General Data Protection Regulations in the EU
27 Min
1 Lesson
$80 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
General Safety and Performance Requirements under the Medical Devices
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
Clinical Evaluation, Investigations and PMCF under MDR
33 Min
1 Lesson
$75 Per person
Major Regulatory Compliance Challenges for the Non-European Industry
29 Min
1 Lesson
$75 Per person
Benefit Risk Assessment
18 Min
1 Lesson
$75 Per person
