| Course | |||||
|---|---|---|---|---|---|
 | European Legal Framework Training objectives:
• Understand the basis of the US & EU Medical Device Regulation
• Understand differences between US and EU regulatory framework
Training content:
• Review of EU regulatory framework for medical devices
•... | ||||
 | European Legal Framework Training objectives:
• Understand MDR compliant technical documentation content and requirements
• Understand Medical Devices risk class impact
• Understand reviewer’s requirements
Training content:
• Introduction to... | ||||
 | Management systems / Public Training Duration: 6 hours
Speaker: Dr Lydie Moreau
Training objectives:
- Understand the QMS principles and the links between the different QMS processes
- Define a QMS architecture
- Establish a roll-out plan for leading the implementation... | ||||
 | Audit and Inspection CARAQA class on MDSAP Introduction
Speaker: Koushik Ayalasomayajula
Objectives:
- Creating awareness by understanding principles and approach of MDSAP program
- Explain the structure and scope of the Medical Device Single Audit... | ||||
 | Audit and Inspection 16 April 13:30-17:30 PM CEST
4h
Training Objectives:
• Learn basic methods on how to organize and conduct efficient internal and supplier audits
• Integrate an internal audit program into the Quality Management System
• Understand... | ||||
 | Clinical & scientific skills Agenda:
Part 1 – Good Clinical Practice and Regulatory Context
Part 2 – Planning and Design of Clinical Investigations
Part 3 – Roles and Responsibilities
Part 4 – Essential Documents
Part 5 – Conduct and Close-out of Clinical... | ||||
 | Clinical & scientific skills Content:
Part 1 – Good Clinical Practice and Regulatory Context
Part 2 – Planning and Design of Clinical Investigations
Part 3 – Roles and Responsibilities
Part 4 – Essential Documents
Part 5 – Conduct and Close-out of Clinical... | ||||
 | Clinical & scientific skills | ||||
 | Clinical & scientific skills 1. Introduction to General Approach and Strategy
2. Objective of Clinical Evaluation
3. How and Where to start?
4. Content of Clinical Evaluation Documents
5. Practical Approach
6. CER for Legacy Devices
7. Concept of Equivalence
8. Intro to... | ||||
 | Clinical & scientific skills Training outline:
Review of Excercise on clinical performance study design
PMS vs PMCF/PMPF
PMCF/PMPF: what and how?
PMCF/PMPF Plan
PMCF/PMPF activities
PMCF/PMPF report
SSCP/SSP
PMCF studies
CER/PER and... |
