First Course

Nebojsa Serafimovic
Nebojsa Serafimovic
Course Hours 16-17.06.23
Lessons 1 Session
$100 Per person

Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications

Course Time 29 Min
Lessons 1 Lesson
$80 Per person

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

Course Time 34 Min
Lessons 1 Lesson
$80 Per person

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

Course Time 22 Min
Lessons 1 Lesson
$70 Per person

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

Course Time 46 Min
Lessons 1 Lesson
$75 Per person

General Data Protection Regulations in the EU

Course Time 27 Min
Lessons 1 Lesson
$80 Per person

Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance

Course Time 29 Min
Lessons 1 Lesson
$75 Per person

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

Course Time 45 Min
Lessons 1 Lesson
$70 Per person

Standards, Harmonisation Process and Common Specifications

Course Time 29 Min
Lessons 1 Lesson
$75 Per person

General Safety and Performance Requirements under the Medical Devices

Course Time 29 Min
Lessons 1 Lesson
$75 Per person

Software, Artificial Intelligence and Cybersecurity in the European Union

Course Time 27 Min
Lessons 1 Lesson
$75 Per person

Issues Arising from the Implementation of the IVD-Regulations

Course Time 28 Min
Lessons 1 Lesson
$80 Per person

Clinical Evaluation, Investigations and PMCF under MDR

Course Time 33 Min
Lessons 1 Lesson
$75 Per person

Major Regulatory Compliance Challenges for the Non-European Industry

Course Time 29 Min
Lessons 1 Lesson
$75 Per person

Benefit Risk Assessment

Course Time 18 Min
Lessons 1 Lesson
$75 Per person