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Medical Device
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Medical Device
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Certificates
Certificates / EN ISO 13485 Quality Management System
Certificates / TS EN ISO / IEC 17025 General requirements for the competence of testing and calibration laboratories
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EN ISO 13485:2016/A11:2021 Medical Devices — Quality Management System
WEBINAR:From Planning to Reporting: MDR Clinical Evaluation – A Notified Body Perspective
Evaluation of the Threshold Value for Trend Analysis
Evaluation of Certain PMCF Activities: PMCF Surveys, Retrospective Studies, High-Quality Surveys
Basic UDI-DI Training
Technical File Review Reporting
Medical Devices for the Collection, Processing, Transportation, andor Storage of Biological Specimens such as Blood, Plasma, Serum, Cells, or Tissues - Including ISO 21973
Approach to Quantifying the Benefit-Risk Ratio
Risk Management: (EU) 2017/745 MDR vs ISO 14971:2019 Requirements
Transition Requirements within the Scope of MDR 120 (TR)-2023
Vigilance Under Regulation (EU)2017745 Training (Turkey)
FR.MED.96, FR.MED.197 Revised Form Training-2023
PSUR Evaluation (Turkey)
PMS & PSUR under Regulation (EU)2017745 training (Turkey)
Technical File Review Reporting and QMS audit reporting; Case Study -2024
Comprehensive Review and Assessment of Technical Documentation in Accordance with the MDR 2017-745
MDR 2017745 ANNEX II and III Technical Documentation Training
Hybrit Audit
ISO 14971 Risk Management in ISO 13485 Product Realization Activities
Material Analysis and Characterization Metal, Polymer and Ceramic
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