SZUTEST ACADEMY: Alle Kurse

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

ISO 14971 Risk Management in ISO 13485 Product Realization Activities

Material Analysis and Characterization Metal, Polymer and Ceramic