MDR Course
Applications for July 2024 Training Have Ended
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)?
If You Do Not Work in a Manufacturing Company, You Have to Pay 7500₺ for Sector Development
You can access the training content by clicking on the PDF file.
Join MDR Course To Get Answers To All Your Questions!
Each participant attending the course will have one question answered.
July 2024 MDR Training Calendar
July 4th
10-12 Pre-Marketing Process - Classification
13-14 Pre-Marketing Process - Technical Documentation
14-17 Pre-Marketing Process - Conformity Assessment
July 5th
10-12 Post-Marketing Process
13-15 Identification and Traceability
15-17 Clinical Process
Training will be provided via online platform.
