MDR Extension According to Regulation 2023/607
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends…
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends…
The definition of the Quality Policy of the organization is one of the essential tasks associated to the top management…
The quality manual is one of the most important documents for a company with a quality system in place, and…
Performing an investigation in case any type of deviation occurs is of fundamental importance nowadays and root-cause analysis methodologies play…
General Requirements It is important to demonstrate that top management reviews the suitability, adequacy and effectiveness of the organization’s quality…
There is no doubt that CAPA (Corrective and Preventive Actions) is one of the most important process of any Quality…
Design History File (DHF) for Medical Devices: Introduction This posts wants to provide an overview of the process of preparation…
Insights into the ISO 13485 certification process for Quality Management System. ISO 13485 certification is the process to certify that…
Eudamed is a database that will be used to monitor both the safety and performance of medical devices distributed in…
The use of statistic for activities related to quality management System is of great importance and both ISO 13485 and…
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