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Contents
01.
Introduction to MDR
02.
Basic Requirements Of MDR
03.
Conformity Assessment Process
04.
Adapting to the MDR
MDR 2017/745
Let's Get to Know the Regulation Closer
01
Introduction to MDR
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Definition and purpose of MDR (Medical Device Regulation)
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Changes in transition from MDD (Medical Device Directive) to MDR
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Basic concepts and definitions of MDR
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The place of medical devices in EU legislation and the relationship of MDR with other regulations
03
Conformity Assessment Process
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Role and selection of notified bodies
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Conformity assessment procedures and modules
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Preparation and presentation of technical file
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Certification and certification process
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Audits and surveillance activities
02
Basic Requirements Of MDR
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Safety and performance requirements
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Clinical evaluation and evidence
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Risk management and risk analysis
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Technical documentation and its content
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Product tracking and traceability
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Market surveillance and complaint management
04
Adapting to the MDR
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Steps to comply with the new obligations of the MDR
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Creating a culture of MDR compliance within the company
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Create and implement an adaptation plan
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Risk assessment and risk management system
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Training and awareness raising activities
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Documentation and recording system
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Internal audit and review
Confused about the Medical Device Regulation (MDR)?
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EÄŸitim Takvimi
4 Temmuz
10-12 Piyasaya Arz Öncesi Süreç - Sınıflandırma
13-14 Piyasaya Arz Öncesi Süreç - Teknik Dokümantasyon
14-17 Piyasaya Arz Öncesi Süreç - Uygunluk DeÄŸerlendirme
5 Temmuz
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13-15 Tanımlama Ve İzlenebilirlik
15-17 Klinik Süreç
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