Course
Regulatory approval (US vs EU) ((EPL15))
European Legal Framework
Regulatory approval (US vs EU) ((EPL15))
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 •...
Technical documentation (US vs EU) ((EPL17))
European Legal Framework
Technical documentation (US vs EU) ((EPL17))
Training objectives:  • Understand MDR compliant technical documentation content and requirements • Understand Medical Devices risk class impact • Understand reviewer’s requirements Training content: • Introduction to...
EN ISO 13485:2016 – Quality Management System (QMS) ((MS08))
Management systems
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Public Training
EN ISO 13485:2016 – Quality Management System (QMS) ((MS08))
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...
MDSAP Introduction (AI05)
Audit and Inspection
MDSAP Introduction (AI05)
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...
Internal and Supplier Audit (AI06)
Audit and Inspection
Internal and Supplier Audit (AI06)
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...
ISO 14155:2020 — Clinical Investigations — Good clinical practice (CSS01)
Clinical & scientific skills
ISO 14155:2020 — Clinical Investigations — Good clinical practice (CSS01)
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...
Study design (CSS06)
Clinical & scientific skills
Study design (CSS06)
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...
Literature Search (CSS11)
Clinical & scientific skills
Literature Search (CSS11)
CER - Clinical Evaluation (CSS12)
Clinical & scientific skills
CER - Clinical Evaluation (CSS12)
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...
PMCF and PMPF (CSS13)
Clinical & scientific skills
PMCF and PMPF (CSS13)
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...

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